The Role of the Setting in Controlling Anxiety and Pain During Outpatient Operative Hysteroscopy: The Experience of a Hysteroscopy Unit in North Italy

Abstract

Background/Objectives: Outpatient operative hysteroscopy is a cornerstone in the management of intrauterine pathologies within reproductive medicine. However, procedural pain and anxiety remain key barriers leading to failed procedures and referrals for surgery under general anesthesia. This study aimed to assess whether a comfort-enhanced procedural environment could reduce perceived pain and increase procedural success rates. Methods: Analysis of 970 consecutive patients who underwent outpatient operative hysteroscopy at the Hysteroscopy Unit of “Degli Infermi” Hospital (Biella, Italy): 470 in 2023 under standard conditions, 500 in 2024 with an enhanced setting. Surgical technique, analgesic/sedation policies and operators were unchanged. The primary outcome was referral to the OR for completion of the procedure. Secondary outcomes included patient-reported pain assessed by Visual Analog Scale (VAS) in a consecutive subsample. Differences between years were evaluated with appropriate parametric/non-parametric tests. Results: Implementation of the enhanced environment was associated with a lower OR referral rate in 2023 versus 2024. Post hoc power for this comparison was approximately 60%. Mean VAS scores also decreased in 2024, with post hoc power >99%. No adverse events were recorded. Conclusions: Environmental and interpersonal modifications were associated with meaningful decline in reported pain and OR referrals. Prospective studies incorporating systematic case-mix and validated anxiety measures are warranted to confirm these results.

1. Introduction

Operative hysteroscopy is a well-established diagnostic and therapeutic technique widely used in gynecology to treat numerous intrauterine pathologies, such as endometrial polyps, submucosal fibroids, intrauterine adhesions, and uterine septa [1,2]. Hysteroscopy has undergone a revolutionary transformation over the past three decades, moving from the confines of the operating room into the outpatient setting. While traditionally considered as a surgically intrusive procedure, usually requiring general anesthesia and hospital admission, nowadays hysteroscopy has evolved into a slightly intrusive, office-based intervention widely used for both diagnostic and therapeutic purposes. Hence, due to its technical and practical advantages, this approach is helpful in minimizing the risks typically associated with conventional surgery. More specifically, the key to this evolution lies in the miniaturization of hysteroscopic equipment, with the introduction of smaller-diameter hysteroscopes, bipolar electrosurgical systems compatible with isotonic saline irrigation. Moreover, the development of other operative instruments such as hysteroscopic morcellators and scissors has allowed gynecologists to perform increasingly complex intrauterine interventions in a safe, efficient, and tolerable manner while performing them on an outpatient basis. In addition, as specified earlier, this innovative approach offers multiple benefits, including faster recovery times, lower complication rates, significant reduction in healthcare costs, and improved quality of life for patients [2]. Amid ongoing budget constraints, extended waiting lists for major surgical procedures, and concerns regarding adequate surgical training for trainees, outpatient hysteroscopy is increasingly recognized as a far more efficient and preferable alternative to traditional, invasive, theatre-based hysteroscopy. Beyond its logistical and clinical benefits, it has also demonstrated a significantly budget-friendly nature and greater cost-effectiveness, with multiple studies demonstrating substantially lower overall expenses compared to procedures conducted in the operating room [3,4,5].

As early as the 1990s, studies began to document the feasibility of office-based hysteroscopic procedures for the management of polyps, fibroids, and retained products of conception (RPOC), establishing the foundation for modern ambulatory gynecological surgery.

Outpatient Operative Hysteroscopy (OOH) is now an essential component of routine gynecological practice. Its primary indications include the evaluation and treatment of abnormal uterine bleeding (AUB), infertility and subfertility workups, endometrial polyps, submucosal fibroids, uterine synechiae, and retained intrauterine devices (IUDs). The ability to perform “see-and-treat” hysteroscopy—where diagnosis and treatment occur in the same session—has increased clinical efficiency and reduced the need for repeat hospital visits. According to a systematic review, outpatient hysteroscopy significantly improves patient access to care and decreases the time from diagnosis to treatment, particularly for endometrial polyps and fibroids less than 2 cm in diameter.

The patient-centered nature of OOH is one of its most important advantages. Unlike traditional hysteroscopic procedures that require anesthesia and prolonged recovery, outpatient procedures are typically performed without sedation or general anesthesia. The vaginoscopic (no-touch) technique, in particular, has been associated with reduced pain, higher tolerability, and decreased procedural times. Furthermore, the avoidance of cervical instrumentation in many cases reduces the incidence of vasovagal reactions and uterine perforations. A large retrospective study by, involving over 5000 patients, reported a success rate of over 95% for outpatient hysteroscopic procedures, with complication rates below 1%. Moreover, OOH plays an important role in the evaluation of infertility. The uterus is a key anatomical component in successful implantation and pregnancy maintenance, and subtle intrauterine abnormalities—often undetectable by ultrasound—can compromise reproductive outcomes. It has been found, that performing hysteroscopy before assisted reproductive techniques (ART) in women with unexplained infertility led to significant improvements in clinical pregnancy and live birth rates. These findings reinforce the utility of hysteroscopy as both a diagnostic and therapeutic tool in reproductive medicine.

The widespread adoption of OOH has also prompted the development of clinical guidelines and training protocols. Leading professional bodies, including the Royal College of Obstetricians and Gynaecologists (RCOG) and the American College of Obstetricians and Gynecologists (ACOG), have published recommendations endorsing office-based hysteroscopy as a standard of care for selected patients. Guidelines emphasize the importance of operator training, appropriate patient selection, informed consent, and adherence to safety protocols, particularly concerning fluid management and the use of electrosurgical energy (RCOG, 2024).

Training in OOH is increasingly incorporated into gynecological residency programs, with simulation-based education and hands-on workshops improving competency. Importantly, procedural success does not appear to be significantly influenced by operator seniority. Studies demonstrated that junior clinicians achieved success rates comparable to those of senior surgeons when supervised appropriately, suggesting that OOH can be effectively taught and safely performed early in clinical training.

Despite these clinical and economic advantages, outpatient hysteroscopy could also have potential delicate elements. The main concern regards how this procedure is actually experienced by the patients. In many cases, it could be perceived as a heavily distressing and potentially traumatic experience [6,7]. Hence, pain and anxiety during the procedure remain important concerns that influence patient satisfaction and the likelihood of successful completion. Several studies have examined the predictors of procedural pain and failure, identifying factors such as cervical stenosis, nulliparity, and high baseline anxiety as significant contributors. The State-Trait Anxiety Inventory (STAI) has been used extensively to evaluate pre-procedural anxiety, with mean scores indicating moderate to high anxiety levels among patients undergoing office hysteroscopy. Managing intra-procedural pain and the accompanying emotional burden remains one of the primary challenges. Pain perception during the procedure varies greatly and is influenced not only by physiological factors, such as cervical length, history of vaginal delivery and the surgeon’s experience, but also by psychological components, including anxiety, fear, prolonged waiting times and previous negative experiences with gynecological examinations [8,9,10,11,12]. In particular, anticipated pain—the level of pain a patient expects or predicts they will experience before undergoing the procedure—may influence actual pain perception during outpatient hysteroscopy, supporting the hypothesis that pre-procedural expectations can modulate the actual pain experience [13,14].

A clear correlation has been established between pre-procedural anxiety levels and intraoperative discomfort, underscoring the importance of comprehensive strategies to enhance the overall patient experience [15]. Both pain and anxiety significantly impact patient tolerance of outpatient hysteroscopy, with elevated anxiety levels—particularly related to anticipated pain—being linked to a preference for future procedures under general anesthesia or even procedural failure [16,17,18]. Such cases not only undermine the efficacy and efficiency of outpatient services but also expose patients to additional risks and prolong the diagnostic or therapeutic process.

Pain management during office hysteroscopy involves various pharmacological and non-pharmacological strategies tailored to patient and procedure characteristics. Some authors confirmed the effectiveness of both approaches with personalized protocols [19], while others identified oral NSAIDs as the safest and most effective analgesics, recommending TENS as an alternative [20]. Furthermore, case-based evidence has demonstrated that complex procedures—such as the hysteroscopic treatment of uterine arteriovenous malformations—can be performed safely, feasibly, and with good patient tolerance in an outpatient setting under local anesthesia, further emphasizing the importance of effective analgesic protocols in enabling minimally invasive care pathways [21]. Outpatient operative hysteroscopy represents a significant advancement in modern gynecological care. Its development has been driven by innovations in technology, a growing emphasis on patient-centered care, and robust evidence supporting its safety, efficacy, and cost-effectiveness. As the field continues to evolve, there is a growing need for continued research, guideline refinement, and equitable access to training and equipment. Outpatient hysteroscopy is not merely a procedural innovation—it is a cornerstone of minimally invasive gynecology and a model of how clinical care can be restructured to better serve both patients and providers. Taken together, these studies support the use of individualized, multimodal pain management strategies to optimize outcomes in office hysteroscopy.

Given these considerations, the emphasis has gradually moved from solely the technical performance of the procedure to a more comprehensive approach that prioritizes the patient’s emotional and psychological well-being at the core of clinical care.

This paradigm shift reflects the wider trend toward patient-centered medicine, which highlights the importance of empathy, communication, and individualized care as essential elements of high-quality healthcare [22].

In this context, the physical characteristics of the healthcare environment (such as lighting, soundscape, access to natural views, and the presence of calming visual or auditory stimuli) are increasingly recognized as influential factors in patient and staff well-being.

Interventions designed to include these elements have been linked to greater patient satisfaction, decreased stress, and better healing outcomes [23,24], just as the communication style and demeanor of healthcare providers can influence patients’ perception of pain [25,26]. A supportive and carefully curated environment—featuring aromatherapy, relaxing background music, a tranquil acoustic setting, and a welcoming ambiance, or even the use of virtual reality technology—has been shown to reduce perceived anxiety, modulate physiological stress responses and pain, and improve tolerance during hysteroscopy as well as other invasive gynecological procedures [24,27,28,29,30,31].

Within this framework, in 2024 the Hysteroscopy Unit of “Degli Infermi” Hospital in Biella (Italy) undertook a substantial environmental redesign aimed at enhancing the outpatient hysteroscopy experience. This transformation involved the integration of multiple sensory and relational elements, including the use of background music, dim and warm ambient lighting, white noise to mask disruptive sounds, and continuous reassuring verbal interaction between healthcare personnel and patients. The underlying objective was to mitigate the neurovegetative activation typically triggered by anxiety and procedural anticipation, thereby improving both the subjective tolerability and the objective success of the intervention.

This study aims to evaluate the impact of this environmental strategy by comparing the referral rate to the operating room in two consecutive years: 2023, during which standard procedural settings were maintained, and 2024, following the introduction of the enhanced setting. The central hypothesis is that a purposefully designed, empathetic environment may serve as a non-pharmacological modulator of anxiety and pain, ultimately increasing the likelihood of completing operative hysteroscopies within the outpatient context.

2. Materials and Methods

A retrospective observational study was conducted at the Hysteroscopy Unit of “Degli Infermi” Hospital in Biella to assess the impact of the procedural setting on patient tolerance during outpatient operative hysteroscopy. A comparison was made between two cohorts who underwent the same procedure during two consecutive years: 2023 (standard environment) and 2024 (comfort-enhanced environment).

Sample

The study included all patients who underwent outpatient operative hysteroscopy between January 2023 and December 2024. The sample consisted of 470 patients in 2023 and 500 patients in 2024.

Detailed case-mix variables such as parity, presence of cervical stenosis, and lesion size/type were not systematically recorded in the clinical dataset underpinning this retrospective analysis and are therefore not available.

To minimize variability, all procedures were performed by the same experienced team following standardized protocols, which helps reduce, but cannot entirely abolish, operator-related variability. The team’s level of experience and role assignments, even if not formally quantified or controlled, did not change across the study periods except for the potential evolution of operator experience.

Inclusion criteria

• Age over 18 years
• Clinical indication for operative hysteroscopy (e.g., endometrial polyps, submucosal fibroids, intrauterine adhesions, uterine septa)
  Exclusion criteria
• Contraindications for outpatient hysteroscopy
• Need for general anesthesia due to clinical reasons

Procedure

In both years, hysteroscopies were performed using miniaturized instruments (≤5 mm in diameter) and saline solution for uterine distension, according to current guidelines aimed at minimizing pain and improving procedural tolerance. Analgesic and sedation practices remained unchanged between 2023 and 2024. Pre-procedure NSAID use, local anaesthetic techniques, and institutional sedation policies were identical across the two periods.

In 2023, procedures were performed in a standard environment, without specific comfort measures.

In 2024, the setting was modified with the following features:

• Soft lighting
• Background relaxing music
• Reduced environmental noise
• Presence of a healthcare assistant dedicated to emotional support

These elements were implemented to create a more comfortable environment and to reduce pre-procedural anxiety, a known factor that negatively influences pain perception during hysteroscopy [13,14].

No staffing changes, protocol modifications relevant to outpatient hysteroscopy, or equipment upgrades affecting clinical practice occurred between the two study years.

Outcomes

Primary outcome

• Referral rate to the operating room (OR) to complete the procedure, considered as an indicator of outpatient hysteroscopy failure
  Secondary outcome
• Perceived pain assessed using the Visual Analog Scale (VAS) in a representative subgroup of 200 patients per year. Visual analogue scale (VAS) scores were recorded for consecutive patients during each study year; the VAS subsample therefore represents an unselected, consecutive series of routine clinical cases.
  Statistical Analysis
  The collected data were analyzed using appropriate statistical software.
  Analysis of categorical variables
  To compare the referral rate to the operating room between 2023 and 2024:
• A Chi-square (χ²) test was used when cell counts met the assumptions for the test
• Fisher’s exact test was applied in case of expected frequencies below 5 (though, with 52/470 vs. 35/500, the chi-square test was appropriate)
  Analysis of continuous variables
  To compare mean VAS pain scores (continuous variables) between groups:
• Normality of data distribution was assessed using the Shapiro–Wilk test or graphical methods (histograms, Q-Q plots)
• If data were normally distributed: Student’s t-test for independent samples was used
• If not normally distributed: Mann–Whitney U test was applied

In this study, the comparison of VAS scores (5.9 ± 1.8 in 2023 vs. 4.1 ± 1.4 in 2024) revealed a statistically significant difference (p < 0.01), indicating a clinically meaningful reduction in perceived pain. Because several case-mix variables were not available for the full cohort, formal statistical comparisons between the VAS subsample and the entire cohort for those variables could not be performed.

Significance threshold

A two-tailed p-value < 0.05 was considered statistically significant for all analyses. Statistical tests were chosen based on the nature of the variables and the characteristics of the sample.

We computed 95% confidence intervals (CIs) for differences in proportions using the Wald approximation and for differences in means using the normal approximation for two independent samples. Post hoc power calculations were performed using standard effect-size metrics (Cohen’s h for proportions and Cohen’s d for means).

3. Results

3.1. Participants’ Characteristics

A total of 970 patients underwent outpatient operative hysteroscopy during the study period: 470 in 2023 and 500 in 2024. The two cohorts were comparable with respect to routinely recorded demographic and clinical variables. The mean age was 44.8 ± 9.2 years in 2023 and 45.1 ± 9.0 years in 2024 (p = 0.62). The distribution of recorded clinical indications (endometrial polyps, submucosal fibroids, intrauterine adhesions and uterine septa) did not differ significantly between the two years (all p > 0.05). Operator assignments and the types of interventions performed were stable across the study periods. We note, however, that several detailed case-mix variables (including parity, presence of cervical stenosis, and lesion size/type) were not systematically recorded in the source dataset and therefore are not available for comparison; this limitation is addressed below.

3.2. Primary Outcome: Referral to Operating Room

Referral to the operating room (OR) for completion of the procedure occurred in 52/470 patients (11.1%) in 2023 and in 35/500 patients (7.0%) in 2024. The absolute difference was −4.06% (95% CI −7.68% to −0.45%), χ² = 4.36, p = 0.037. This represents a relative reduction of 36.9% in OR referrals after implementation of the comfort-enhanced environment and corresponds approximately to a number-needed-to-treat (NNT) of ~25 to prevent one OR referral. Post hoc power to detect the observed difference in referral rates (α = 0.05, two-sided) was approximately 60%, indicating moderate but suboptimal power for this endpoint; consequently the estimate should be interpreted with caution.

3.3. Secondary Outcome: Perceived Pain

Perceived pain was assessed by VAS in a representative subsample of consecutive patients (n = 200 per year). Mean VAS decreased from 5.9 ± 1.8 in 2023 to 4.1 ± 1.4 in 2024 (mean difference −1.8; 95% CI −2.12 to −1.48; t = 12.1, p < 0.001). The post hoc power for the VAS comparison was >99%, indicating the study was highly powered to detect the observed difference. No adverse events related to the procedure or the environmental modifications were reported in either year.

3.4. Summary of Findings

Figure 1 summarizes these findings. Implementation of a comfort-enhanced procedural environment in 2024, characterised by soft lighting, relaxing background music, reduced environmental noise and the availability of a dedicated emotional support assistance, was associated with a clinically meaningful and statistically robust reduction in patient-reported pain (mean VAS reduction −1.8 points, 95% CI −2.12 to −1.48; post hoc power > 99%). A concurrent reduction in OR referral rates was observed (absolute difference −4.06%; 95% CI −7.68% to −0.45%; p = 0.037), corresponding to an approximate NNT of 25; however, this endpoint had only moderate post hoc power and should therefore be considered suggestive rather than definitive. The absence of systematically recorded case-mix details (parity, cervical stenosis, lesion size/type) is a limitation that could contribute to residual confounding and is further discussed in the Limitations section.

4. Discussion

This study provides robust evidence that the procedural environment significantly impacts the outcomes of outpatient operative hysteroscopy. The implementation of an enhanced setting in 2024 was associated with decreased pre-procedural anxiety and improved pain perception by the women. Furthermore, it was correlated with a statistically significant reduction in referrals to the operating room, findings that underscore the importance of environmental and interpersonal factors in optimizing patient experience and procedural success. However, while the VAS reduction is statistically robust and likely clinically meaningful, the observed decrease in OR referrals should be interpreted with caution because its confidence interval includes values compatible with no effect, and the post hoc power for this endpoint is limited.

Stress and anxiety in the preoperative setting have been shown to significantly lower pain thresholds and tolerance [9,32]. Even minimally invasive procedures such as hysteroscopy may elicit significant emotional and physiological stress responses, particularly in patients with a history of negative gynecological experiences. This is consistent with evidence showing that perceived threat, even in the absence of overt pain, can activate the hypothalamic–pituitary–adrenal axis and sympathetic nervous system, leading to heightened cortisol secretion and sensitized stress response [33]. These responses may lead to involuntary pelvic muscle contractions, reduced patient cooperation, and premature termination of the procedure, thus compromising clinical outcomes [34]. This evidence reflects recent physiological models in which psychoneuroendocrine responses have a fundamental role in procedural tolerance, proposing that any interventions aimed at reducing sympathetic arousal could potentially influence the patient’s pain experience and clinical outcome [35]. In this contest the dedicated studio was implemented by several environmental modifications such as soft and warm lighting, soothing background music and the presence of a healthcare assistant dedicated to emotional support was guaranteed. Those non-pharmacological interventions to reduce anxiety during hysteroscopy, promoting relaxation and improving procedural tolerability showed excellent results supported by several randomized controlled trials (RCTs) [9,31,36,37].

More recently, virtual reality (VR) has emerged as a highly effective immersive technique for modulating procedural anxiety. Indeed, in support of this claim, a randomized, controlled trial conducted in 2023 demonstrates that VR is able to dramatically and significantly reduce pre-procedural anxiety scores (NRS 3.29 vs. 4.73, p = 0.03) [35], while a comprehensive meta-analysis conducted in 2024 confirmed substantial reductions through the use of VR interventions in both pain and anxiety in outpatient hysteroscopic procedures [30]. These interventions can also change the neurohormonal and immune stress response to the invasive procedure [38]. Our findings are consistent with prior research demonstrating that the women report a significant reduction in pain during outpatient gynecologic procedures when multisensory environmental adjustments are applied [28,29]. Furthermore, our experience strengthened the importance of incorporating empathetic communication and continuous verbal reassurance from healthcare staff. Those verbal relaxing techniques help to reduce anxiety and positively influence pain perception, underscoring the vital role of relational dynamics in the care environment [39,40]. Such implementations in our daily clinical practice stem from the knowledge drawn from numerous industry studies. This evidence points out that empathic caregiver behaviour, such as maintaining eye contact with the patient, using a calm, quiet tone of voice, and verbal encouragement is directly associated with lower outcomes in pain scores and significantly improved satisfaction [9]. From a healthcare system perspective, reducing the frequency of referrals to the operating room carries significant benefits. It translates into decreased healthcare costs, minimizes anesthesia-associated risks, and enables more efficient use of surgical resources by reserving operating rooms for cases that require general anesthesia or more complex procedures [3,4,5]. In fact, although the outcome of the outpatient procedure reaches or even improves on the level of procedures completed in the operating room, the implementation of such an outpatient regimen allows enormous and efficient cost containment (up to about 65 percent) compared to their inpatient counterparts [41].

Despite these encouraging results, this study has inherent limitations. Its retrospective, single-center design limits the ability to establish causality and reduces generalizability. Additionally, potential confounding variables—such as patient psychological profiles and procedural technique variability—were not controlled for and may have influenced outcomes. Objective measures of long-term patient satisfaction and functional outcomes were not collected, representing a critical area for future research. The absence of systematically collected case-mix variables (e.g., parity, cervical stenosis, lesion size/type) represents another limitation and may contribute to residual confounding that we were unable to adjust for.

Although pre-procedural anxiety was central to our conceptual model, no validated anxiety instrument was incorporated into routine data collection because this study was a retrospective analysis of clinical records and standardized questionnaires were not part of the clinical workflow; consequently, validated anxiety scores are unavailable, which limits our ability to assess anxiety as a mediator of pain or procedural outcomes.

In the next future, the research developments should include prospective, multicenter RCTs that incorporate both clinical outcomes and also patient-reported experience measures (PREMs), cortisol biomarkers, and real-time physiologic monitoring to understand the full scope and the role of psychophysiological responses. Prospective studies should incorporate also validated measures of anxiety (e.g., STAI, HADS-anxiety subscale, or GAD-7) to allow formal mediation analyses and better characterize the psychological mechanisms underlying changes in patient-reported pain, as well as long-term patient satisfaction, return to daily activities capability, and psychological well-being. Incorporating patient-reported experience measures (PREMs) and qualitative analyses could deepen understanding of the subjective impact of environmental and communication strategies. Stratification by demographic and psychological factors may enable tailored, patient-centred approaches that maximize procedural tolerance and satisfaction.

In summary, this study supports the adoption of thoughtfully designed environmental and relational interventions as effective, low-cost adjuncts to enhance outpatient operative hysteroscopy. Emphasizing both physical comfort and emotional support aligns with evolving patient-centred care models and represents a promising avenue for humanizing gynecological practice while improving clinical outcomes.

5. Conclusions

This study conducted at the Hysteroscopy Unit of “Degli Infermi” Hospital in Biella demonstrates that an optimized procedural environment significantly enhances patient outcomes during outpatient operative hysteroscopy. By minimizing anxiety-provoking stimuli and fostering an empathetic patient-provider relationship, the enhanced setting improved procedure tolerability, evidenced by a marked reduction in referrals for general anesthesia and better self-reported pain and anxiety scores.

These findings reinforce the pivotal influence of environmental factors in shaping the patient’s experience and procedural success. The interventions implemented were cost-effective, straightforward, and readily applicable, offering a practical model to elevate outpatient surgical care consistent with contemporary patient-centered and humanized healthcare paradigms.

The continuous effort in research and innovation, together with the exploration of immersive techniques such as VR, integration of wearable physiological monitoring, and inclusion of PREMs in clinical workflows, could lead to a drastic but fundamental revolution in the outpatient gynecologic practice. Nonetheless, limitations such as the retrospective, single-center design restrict the generalizability of these findings. Further prospective, multicenter studies with larger patient cohorts are needed to validate these results and to better understand the underlying psychophysiological mechanisms through which environmental modifications influence pain and anxiety during hysteroscopy. Gaining such insights would support the development of standardized, evidence-based protocols aimed at optimizing outpatient hysteroscopic care and significantly improving patient satisfaction.