Abstract
Objective
Gynecologic examinations often provoke anxiety, embarrassment, and a perceived loss of control. Valid, patient‐focused tools that specifically quantify examination‐related anxiety remain limited. This study developed and validated the gynecologic examination anxiety scale (GEAS).
Methods
In a methodological study conducted in Turkey (October 1, 2023–April 1, 2024), women aged 18–65 years with prior gynecologic examination experience completed an online survey disseminated via social networks. Item generation yielded 44 candidates. Content validity was assessed by 17 experts using the Lawshe approach; four items were removed and minor edits followed a 10‐person cognitive pretest, producing a 40‐item draft. Psychometric evaluation comprised exploratory factor analysis and confirmatory factor analysis, plus reliability testing.
Results
Data from 400 participants were analyzed. Sampling adequacy was acceptable (Kaiser–Meyer–Olkin (KMO) = 0.835; Bartlett's test of sphericity p < 0.001). Iterative refinement produced a 20‐item, five‐factor solution‐healthcare personnel approach (4 items), healthcare personnel experience (5), negative experiences (5), hygiene concerns (3), and individual attitudes (3) explaining 60.18% of variance. Model fit was acceptable (chi‐square/degrees of freedom [χ2/df] = 2.722; goodness of fit index [GFI] = 0.903; adjusted goodness of fit index [AGFI] = 0.872; comparative fit index [CFI] = 0.905; Tucker‐Lewis index [TLI] = 0.908; root mean square error of approximation [RMSEA] = 0.066; standardized root mean square residual [SRMR] = 0.080). Internal consistency was good for the total scale (α = 0.867) and adequate across subscales (α = 0.685–0.818). Temporal stability was excellent (ICC = 0.897; n = 105 retested ≥2 weeks).
Conclusion
The GEAS is a brief, valid, and reliable instrument that captures anxiety specific to gynecologic examination and is suitable for clinic‐level screening/triage, tailoring of trauma‐informed care, and quality‐improvement efforts.
Keywords: anxiety, examination, gynecology, reliability, scale development, validity
1. INTRODUCTION
Pelvic (gynecologic) examinations are central to women's preventive care and diagnosis, yet a substantial proportion of women report fear, anxiety, embarrassment, pain, and loss of control before or during the examination, which can deter care‐seeking and compromise screening uptake. 1 , 2 , 3 Across systematic and narrative reviews, the prevalence of fear/embarrassment/anxiety associated with pelvic examinations ranges from approximately 10% to 80% (median; 34%), although study quality and measures vary. 4 , 5 Qualitative work consistently highlights drivers such as anticipated pain from the speculum, exposure of intimate body parts, privacy breaches, prior negative experiences, inadequate communication, and gender‐role expectations, all of which amplify psychological distress around the examination. 6 , 7
Anxiety related to pelvic examinations is clinically meaningful: it predicts delay or avoidance of routine gynecologic care and screening 1 and is frequently reported among women undergoing evaluation after abnormal cervical screening results. 6 , 8 As health systems expand options such as self‐collected human papillomavirus (HPV) testing, many patients cite improved comfort, privacy, and reduced embarrassment compared with speculum‐based smear testing underscoring how procedure‐related anxiety shapes preferences and adherence. 9 , 10
Despite its importance, research has largely relied on general anxiety scales (The State–Trait Anxiety Inventory [STAI], Hospital Anxiety and Depression Scale [HADS]) that do not capture situation‐specific cognitions and fears unique to the pelvic examination. 6 , 7 To our knowledge, the few procedure‐specific instruments target other populations or perspectives; for example, the fear of pelvic examination scale (F‐PEXS) was designed and validated for medical students' fear of performing pelvic examinations, not for patients' anxiety while undergoing the examination. 11 This underscores a persistent measurement gap: there is no widely adopted, psychometrically validated scale that comprehensively assesses women's anxiety specifically about undergoing gynecologic examination, including domains such as perceived privacy/dignity, clinician approach, anticipated pain, hygiene concerns, and prior negative experiences.
Developing a brief, valid, and reliable gynecologic examination anxiety scale (GEAS) could (i) enable accurate screening and stratification of examination‐related anxiety in clinical and public‐health settings; (ii) guide targeted interventions (trauma‐informed communication, chaperone/support person, positioning and speculum techniques) known to reduce distress 2 , 4 and (iii) facilitate evaluation of service innovations (self‐collection pathways) through a patient‐centered outcome lens. 7 , 12 In response to this need, the present methodological study aimed to develop and validate a patient‐focused instrument to measure anxiety during gynecologic examination.
2. MATERIALS AND METHODS
2.1. Study design and setting
This methodological scale‐development study was conducted between October 1, 2023 and April 1, 2024 using an online questionnaire administered via social networking platforms to women residing in different geographic regions of Turkey. As this study did not include an experimental design or intervention, no group assignment or randomization procedures were performed. All participants were included in a single analytical sample for psychometric evaluation.
2.2. Participants and eligibility
Inclusion criteria were women aged 18–65 years who had previously undergone a gynecologic examination, were literate, and provided electronic informed consent. Because several candidate items explicitly referenced speculum‐based experiences and sexuality‐related cognitions, the initial validation targeted sexually active women to maintain conceptual alignment during item calibration; this scope is acknowledged as a limitation for external validity and motivates future validation in non‐sexually active populations. Exclusion criteria comprised a first‐ever gynecologic examination and examinations performed under exceptional circumstances (harassment/rape).
2.3. Sampling and sample size
A non‐probability convenience approach with chain‐referral (snowball) recruitment was used: the survey link was posted on social networks and could be forwarded by respondents across their contacts. Probability (random) sampling was not employed; representativeness therefore cannot be assumed and generalizability is discussed in the limitations. Consistent with scale‐development guidance (5–10 participants per item), the content‐validated draft (40 items) informed a target of 10 participants per item; n = 400 complete responses were obtained for psychometric analyses. For temporal stability, the identical survey was readministered ≥2 weeks later, yielding 105 matched test–retest responses identified via a user‐defined nickname.
2.4. Data collection tools and measures
2.4.1. Descriptive information form
A researcher‐developed 10‐item form captured sociodemographic and contextual characteristics.
2.4.2. Gynecologic examination anxiety scale draft
An initial 44‐item pool was generated from literature and field observations to capture anxiety specific to gynecologic examination; items were scored on a five‐point Likert scale (1 = strongly disagree to 5 = strongly agree).
2.5. Content validity and cognitive pretest
Content validity was evaluated by 17 experts using the Lawshe content validity ratio (CVR) method. Four items below the minimum acceptable CVR threshold for 17 experts (CVR < 0.529) were removed, yielding a 40‐item draft. The scale‐level CVI (S‐CVI/Ave) for retained items was 0.76. Although several items had CVR values close to the minimum acceptable threshold (e.g., 0.53), they were retained based on theoretical relevance and expert consensus, and were further supported by satisfactory factor loadings in subsequent analyses. Expert feedback informed wording and cultural appropriateness revisions. A cognitive pretest with 10 women (outside the analytic sample) assessed clarity, comprehensibility, and response processes; minor editorial refinements were made prior to fielding the main survey.
Following the content validity analysis, items that did not meet the required CVR threshold were removed. Subsequently, the remaining items were renumbered before proceeding to exploratory and confirmatory factor analyses.
2.6. Data collection procedures
After reviewing study information and consenting online, participants completed the questionnaire on a secure web form. For the retest, the same link was redistributed ≥2 weeks later; participants re‐entered their predefined nickname to enable matching.
2.7. Statistical analysis
Statistical analyses were conducted using IBM SPSS Statistics (version 26.0; IBM Corporation, Armonk, New York, USA) for exploratory data analysis, descriptive statistics, and reliability testing. Confirmatory factor analysis (CFA) and structural equation modeling (SEM) were performed using IBM SPSS AMOS (version 21.0; IBM Corporation). All structural models were estimated using the maximum likelihood method, and the model fit was evaluated based on standard indices, including the comparative fit index (CFI), the root mean square error of approximation (RMSEA), and the standardized root mean square residual (SRMR).
Exploratory factor analysis (EFA) was conducted on the 40‐item draft using principal component analysis (PCA) with varimax rotation to examine dimensionality and refine the item pool. Sampling adequacy and sphericity were assessed using the Kaiser–Meyer–Olkin (KMO) measure and Bartlett's test of sphericity. Items with problematic cross‐loadings, forming singleton factors, or undermining interpretability were iteratively removed, resulting in a 20‐item, five‐factor solution explaining 60.18% of the total variance. Although varimax (orthogonal) rotation was applied, interfactor correlations were examined and found to be within acceptable limits, supporting the interpretability of the factor structure.
CFA tested the EFA‐derived model using standard fit indices (chi‐square/degrees of freedom [χ2/df], goodness of fit index [GFI]/adjusted goodness of fit index [AGFI], CFI/Tucker Lewis index [TLI], RMSEA, SRMR) and inspected standardized loadings.
Reliability was assessed via Cronbach's alpha for the total scale and subdimensions, and test–retest stability using intraclass correlation coefficients (ICC) on the 105‐participant subset; statistical significance was set at α = 0.05.
2.8. Ethical aspects of the research
Before the research, an application was made to Istanbul Gedik University Ethics Committee and ethics committee approval was obtained at the meeting dated September 14, 2023 and numbered 2023/9. Before the data collection form, the researchers were asked to confirm their voluntary participation in the section in the questionnaire form. Those who confirmed their participation in the study were included in the study.
2.9. Methodological considerations and limitations
Online snowball recruitment may introduce selection biases (the observed concentration of university‐educated and married participants), which can limit generalizability; these patterns are described in the sample characteristics and considered in interpretation. The cognitive pretest (n = 10) was designed to assess clarity and response process, not to estimate psychometric properties; evidence for internal structure and stability is provided by the main‐study EFA/CFA and test–retest analyses. The initial restriction to sexually active women narrows the intended population. Future validation should examine measurement invariance and performance in non‐sexually active women.
3. RESULTS
The overall process of scale development and validation is presented in Figure 1. Among the women who participated in the study, 39.5% were in the 30–39 age group, and the mean age was 34.78 ± 8.71 years. Of the participants, 81.3% were married, 76.3% were employed, 85% had a university degree, and 64% reported an income equal to their expenses. Additionally, 57.3% of the women stated they lived in the western regions of Turkey (Marmara, Aegean), 78.8% indicated they never or rarely underwent an annual gynecologic examination, 50.2% preferred private hospitals for these examinations, and 78.5% reported no gynecologic conditions requiring regular check‐ups (Table 1).
FIGURE 1.
Flow diagram of the scale development and validation process.
TABLE 1.
Distribution of descriptive characteristics.
| Variables | Number | Percentage |
|---|---|---|
| Age, mean ± SD = 34.78 ± 8.71 (min: 19, max: 65) | ||
| Age groups | ||
| 19–29 years old | 115 | 28.7 |
| 30–39 years | 158 | 39.5 |
| 40 years and older | 127 | 31.8 |
| Marital status | ||
| Single | 75 | 18.7 |
| Married | 325 | 81.3 |
| Employment status | ||
| Working | 305 | 76.3 |
| Not working | 95 | 23.7 |
| Education status | ||
| High school and below | 60 | 15.0 |
| University and above | 340 | 85.0 |
| Income status | ||
| Income less than expenditure | 60 | 15.0 |
| Income more than expenditure | 84 | 21.0 |
| Income matches expenditure | 256 | 64.0 |
| Region of residence | ||
| West (Marmara, Aegean) | 229 | 57.2 |
| East (Eastern Anatolia, South Eastern Anatolia) | 37 | 9.3 |
| In the middle (Black Sea, Central Anatolia, Mediterranean) | 134 | 33.5 |
| Previous childbirth status | ||
| Yes | 249 | 62.3 |
| No. | 151 | 37.7 |
| Annual frequency of gynecologic examination | ||
| 2–4 times | 74 | 18.5 |
| 5 times or more | 11 | 2.7 |
| Never or once | 315 | 78.8 |
| Hospital preference for gynecologic examination | ||
| State hospital | 148 | 37.0 |
| Private hospital | 201 | 50.2 |
| Private practice | 51 | 12.8 |
| Presence of gynecologic diseases requiring continuous examination | ||
| There is | 86 | 21.5 |
| There is not | 314 | 78.5 |
Note: Mean: Average, SD.
Abbreviations: max, maximum; min, minimum; SD, standard deviation.
Table 2 shows that CVRs were calculated for 44 items based on responses from 17 experts. Items 3, 9, 14, and 18 were excluded from the scale because their CVR values were below the minimum acceptable threshold for 17 experts (CVR < 0.529). After these items were removed, the scale‐level content validity index (CVI) was calculated as the average of the retained items and found to be 0.76, indicating acceptable content validity.
TABLE 2.
Scale CVR values according to expert opinions.
| Item no | Unnecessary | Useful/inadequate | Required | CVR |
|---|---|---|---|---|
| 1 | 0 | 0 | 17 | 1.00 |
| 2 | 0 | 1 | 16 | 0.88 |
| 3 | 2 | 3 | 12 | 0.41 |
| 4 | 1 | 1 | 15 | 0.76 |
| 5 | 2 | 1 | 14 | 0.65 |
| 6 | 0 | 0 | 17 | 1.00 |
| 7 | 1 | 0 | 16 | 0.88 |
| 8 | 0 | 0 | 17 | 1.00 |
| 9 | 1 | 4 | 12 | 0.41 |
| 10 | 0 | 1 | 16 | 0.88 |
| 11 | 1 | 1 | 15 | 0.76 |
| 12 | 0 | 2 | 15 | 0.76 |
| 13 | 0 | 3 | 14 | 0.65 |
| 14 | 2 | 4 | 11 | 0.29 |
| 15 | 1 | 3 | 13 | 0.53 |
| 16 | 0 | 4 | 13 | 0.53 |
| 17 | 3 | 1 | 13 | 0.53 |
| 18 | 2 | 3 | 12 | 0.41 |
| 19 | 2 | 1 | 14 | 0.65 |
| 20 | 0 | 1 | 16 | 0.88 |
| 21 | 0 | 0 | 17 | 1.00 |
| 22 | 0 | 1 | 16 | 0.88 |
| 23 | 2 | 2 | 13 | 0.53 |
| 24 | 0 | 1 | 16 | 0.88 |
| 25 | 4 | 0 | 13 | 0.53 |
| 26 | 1 | 3 | 13 | 0.53 |
| 27 | 0 | 3 | 14 | 0.65 |
| 28 | 1 | 1 | 15 | 0.76 |
| 29 | 2 | 1 | 14 | 0.65 |
| 30 | 2 | 1 | 14 | 0.65 |
| 31 | 1 | 1 | 15 | 0.76 |
| 32 | 1 | 0 | 16 | 0.88 |
| 33 | 4 | 0 | 13 | 0.53 |
| 34 | 0 | 1 | 16 | 0.88 |
| 35 | 2 | 0 | 15 | 0.76 |
| 36 | 1 | 0 | 16 | 0.88 |
| 37 | 2 | 0 | 15 | 0.76 |
| 38 | 2 | 0 | 15 | 0.76 |
| 39 | 2 | 2 | 13 | 0.53 |
| 40 | 0 | 2 | 15 | 0.76 |
| 41 | 1 | 0 | 16 | 0.88 |
| 42 | 1 | 0 | 16 | 0.88 |
| 43 | 0 | 3 | 14 | 0.65 |
| 44 | 1 | 0 | 16 | 0.88 |
Note: Bold values indicate items excluded from the scale because their CVR values were below the minimum acceptable threshold for 17 experts (CVR < 0.529).
Abbreviation: CVR, content validity ratio.
Table 3 shows a KMO value of 0.835. As this value lies between 0 and 1 and is closer to 1, it indicates the data's suitability for factor analysis and a reliable factor structure. Bartlett's test of sphericity results also confirmed strong intervariable relationships, suggesting that the dataset was appropriate for factor analysis (p < 0.001).
TABLE 3.
KMO value and Bartlett's test of sphericity results of GEAS.
| KMO | 0.835 | |
| Bartlett's test of sphericity | X2 | 3041.809 |
| SD | 190 | |
| p: level of significance | 0.000*** | |
Note: ***p < 0.001. Bold values indicate statistically significant results.
Abbreviations: χ2, chi‐square; GEAS, gynecologic examination anxiety scale; KMO, Kaiser Meyer Olkin; SD, standard deviation.
Table 4 outlines the presence of five factors with eigenvalues greater than 1. These factors are determined using the eigenvalue method, with eigenvalues above 1 signifying factor structures. Furthermore, the explained variance ratio illustrates the strength of the factor structure. Factor 1 (4 items) accounts for 13.939% of the total variance, factor 2 (5 items) for 13.742%, factor 3 (5 items) for 11.675%, factor 4 (3 items) for 10.774%, and factor 5 (3 items) for 10.050%. Collectively, these five factors with 20 items explain 60.180% of the total variance.
TABLE 4.
Variance explanation table of the GEAS.
| Factor | Results without rotation | Results with varimax rotation | ||||
|---|---|---|---|---|---|---|
| Core value | Explained variance % | Cumulative % | Core value | Explained variance % | Cumulative % | |
| Factor 1 | 5855 | 29 276 | 29 276 | 2788 | 13 939 | 13 939 |
| Factor 2 | 2265 | 11 326 | 40 602 | 2748 | 13 742 | 27 681 |
| Factor 3 | 1424 | 7121 | 47 722 | 2335 | 11 675 | 39 355 |
| Factor 4 | 1311 | 6553 | 54 276 | 2155 | 10 774 | 50 129 |
| Factor 5 | 1181 | 5904 | 60 180 | 2010 | 10 050 | 60 180 |
Abbreviation: GEAS, gynecologic examination anxiety scale.
Table 5 indicates that the CFA results for the GEAS demonstrated acceptable model fit across all indices.
TABLE 5.
Fit index values and good fit values of the measurement model of the GEAS.
| Model fit index values | Good fit values (acceptable compliance) | |
|---|---|---|
| χ2/DF | 2.722 | ≤3 (4–5) |
| GFI | 0.903 | ≥ 0.90 (0.89–0.85) |
| AGFI | 0.872 | ≥ 0.90 (0.89–0.85) |
| IFI | 0.906 | ≥ 0.95 (0.94–0.90) |
| TLI (NNFI) | 0.908 | ≥ 0.95 (0.94–0.90) |
| CFI | 0.905 | ≥ 0.95 (0.94–0.90) |
| RMSEA | 0.066 | ≤ 0.05 (0.06–0.08) |
| SRMR | 0.080 | ≤ 0.05 (0.06–0.08) |
Abbreviations: AGFI, adjusted goodness of fit index; CFI, comparative fit index; χ2/DF, chi‐square/degrees of freedom; GEAS, gynecologic examination anxiety scale; GFI, goodness of fit index; IFI, incremental fit index; RMSEA, root mean square error of approximation; SRMR, standardized root mean square residual; TLI (NNFI), Tucker‐Lewis index/non‐normed fit index.
Table 6 shows that the factor loadings for all items on the GEAS exceeded 0.500.
TABLE 6.
Factor loadings of the GEAS (renumbered items) after CFA.
| Items | Factor 1 | Factor 2 | Factor 3 | Factor 4 | Factor 5 |
|---|---|---|---|---|---|
| Item_13 | 0.508 | ||||
| Item _15 | 0.525 | ||||
| Item _12 | 0.941 | ||||
| Item _11 | 0.917 | ||||
| Item _10 | 0.559 | ||||
| Item_28 | 0.545 | ||||
| Item _16 | 0.780 | ||||
| Item _17 | 0.748 | ||||
| Item _39 | 0.513 | ||||
| Item_40 | 0.554 | ||||
| Item_23 | 0.692 | ||||
| Item_18 | 0.571 | ||||
| Item _22 | 0.618 | ||||
| Item_21 | 0.552 | ||||
| Item_3 | 0.544 | ||||
| Item _6 | 0.877 | ||||
| Item _5 | 0.891 | ||||
| Item _26 | 0.578 | ||||
| Item _24 | 0.626 | ||||
| Item_25 | 0.759 |
Note: Item numbers represent the renumbered items after removal based on content validity analysis.
Abbreviations: CFA, confirmatory factor analysis; GEAS, gynecologic examination anxiety scale.
Table 7 highlights that the 20‐item GEAS achieved high reliability (α = 0.867). Reliability scores for individual factors were also high: Factor 1 (healthcare personnel approach; 4 items, α = 0.818), factor 2 (healthcare personnel experience; 5 items, α = 0.726), factor 3 (negative experiences; 5 items, α = 0.737), factor 4 (hygiene concerns; 3 items, α = 0.805), and factor 5 (individual attitudes; 3 items, α = 0.685).
TABLE 7.
Reliability analysis results of the GEAS.
| Number of items | Cronbach's alpha (α) | Reliability level | |
|---|---|---|---|
| GEAS | 20 | 0.867 | Good |
| Factor 1: Approach of health personnel | 4 | 0.818 | Good |
| Factor 2: Experience of health personnel | 5 | 0.726 | Acceptable |
| Factor 3: Negative experiences | 5 | 0.737 | Acceptable |
| Factor 4: Hygienic reasons | 3 | 0.805 | Good |
| Factor 5: Individual attitudes | 3 | 0.685 | Questionable |
Abbreviation: GEAS, gynecologic examination anxiety scale.
Table 8 presents the ICC results for 105 participants, which assessed the scale's invariance over time. A strong agreement was observed between scores from the first and second applications, confirming the scale's reliability (p < 0.001). The high consistency between the two administrations indicates that the scale is stable and reliable over time. Test–retest reliability was assessed using a two‐way mixed‐effects model with absolute agreement. Single‐measure ICC values and 95% confidence intervals (CIs) were calculated.
TABLE 8.
Intraclass correlation coefficient between test–retest scores of the GEAS.
| ICC | p value | |
|---|---|---|
| GEAS | 0.897 | 0.000* |
| Factor 1: Approach of health personnel | 0.754 | 0.000* |
| Factor 2: Experience of health personnel | 0.752 | 0.000* |
| Factor 3: Negative experiences | 0.835 | 0.000* |
| Factor 4: Hygienic reasons | 0.777 | 0.000* |
| Factor 5: Individual attitudes | 0.857 | 0.000* |
Note: p = significance level, *p < 0.001. Bold values indicate statistically significant results.
Abbreviations: GEAS, gynecologic examination anxiety scale; ICC, intraclass correlation coefficients.
4. DISCUSSION
We developed and validated a 20‐item, five‐factor instrument that specifically assesses anxiety related to gynecologic examination. The scale showed acceptable fit in CFA (χ2/df = 2.72; GFI = 0.903; AGFI = 0.872; CFI = 0.905; TLI = 0.908; RMSEA = 0.066; SRMR = 0.080), strong internal consistency (α = 0.867) and excellent test–retest reliability (ICC = 0.897). After the content validity phase, item removal and renumbering were performed, which may explain differences in item numbering across analysis stages. Items with borderline CVR values were retained based on theoretical considerations and were supported by acceptable factor loadings, which supports their inclusion in the final scale. The scale‐level CVI (0.76) was below commonly recommended thresholds, which should be considered when interpreting the content validity of the instrument.
These indices meet commonly used thresholds for model fit and reliability in health measurement. 13 , 14 , 15 The factor content, clinician approach/experience, prior negative experiences, hygiene/privacy concerns, and individual attitudes, maps onto determinants repeatedly described in qualitative and review literature on pelvic‐examination distress, suggesting good content and construct representation. 6
Anxiety, embarrassment, anticipated pain, and perceived loss of control are common around pelvic examinations and can deter preventive care and follow‐up. 16 , 17 Prior studies typically relied on general anxiety measures (STAI/HADS) that do not fully capture procedure‐specific fears (communication quality, exposure/draping, speculum discomfort). Our instrument addresses this measurement gap, complementing existing tools that assess other perspectives. 18
Beyond measurement, policy and service innovations heighten the clinical value of an examination‐specific anxiety scale. The United States Preventive Services Task Force (USPSTF's) 2024 draft explicitly includes self‐collected HPV testing as an option for primary screening in ages 30–65, reflecting growing evidence that self‐collection is accurate with PCR‐based assays and may enhance acceptability for some patients. 19 , 20 , 21 Our scale provides a patient‐reported outcome to quantify whether such pathway changes (offering self‐collection in clinic) translate into lower examination‐related anxiety and improved experiences.
Routine administration at intake can identify high‐anxiety patients who may benefit from additional preparation, choice, and supportive presence. 22 Scores can inform trauma‐informed care workflows: anticipatory guidance, explicit consent and pause options, preference‐sensitive speculum choice, gender‐concordant chaperone, and attention to triggers.
Randomized evidence indicates that no‐stirrups positioning reduces perceived vulnerability and discomfort during speculum examinations 23 and multiple RCTs show that small amounts of water‐based gel reduce insertion pain without compromising cytology adequacy when carbomer‐containing gels are avoided. 24 , 25 , 26 Our scale can serve as a responsive patient‐reported outcome measure (PROM) to monitor the impact of implementing such low‐cost changes in clinics.
For under‐screened groups who cite embarrassment, exposure and discomfort as key barriers, discussing self‐collection (where guideline‐concordant) alongside strategies to improve the in‐clinic experience may increase participation. Tracking our scale alongside uptake and completion enables continuous quality improvement. 17
4.1. Strengths and limitations
Strengths include rigorous content validation with 17 experts (Lawshe CVR/CVI), EFA–CFA‐based structural evaluation, and test–retest assessment of temporal stability. Reporting aligns with COnsensus‐based Standards for the selection of health Measurement INstruments (COSMIN) guidance on PROM development and content validity. 27
Several limitations should be considered. First, online snowball recruitment is subject to coverage and self‐selection bias, which likely contributed to the over‐representation of married and highly educated participants, thereby limiting generalizability. 28 Second, the initial validation focused on sexually active women to align with item content (e.g., speculum‐related experiences), which may restrict applicability to broader populations; future studies should examine measurement invariance across sexual activity status, age, parity, and marital status. 15 Third, the cross‐sectional, self‐report design introduces the possibility of common‐method bias.
A further methodological limitation is that both EFA and CFA were conducted on the same dataset, which may increase the risk of model overfitting and inflated fit indices; therefore, findings should be interpreted with caution, and future studies should validate the factor structure in independent samples.
In addition, construct validity was not assessed through convergent or known‐groups analyses, which represents an important limitation. Therefore, the validity of the scale is currently limited to structural validity and reliability, and further studies are required to establish its construct validity.
Finally, the scale‐level CVI (0.76) was below commonly recommended thresholds, which should be considered when interpreting the content validity of the instrument.
5. CONCLUSION
We developed and psychometrically validated a 20‐item, five‐factor instrument to assess anxiety specifically related to gynecologic examination. The scale demonstrated acceptable structural fit, good internal consistency, and excellent test–retest stability, indicating that it captures examination‐specific cognitions and emotions that are not fully measured by generic anxiety tools. As a brief, patient‐reported outcome, it is suitable for screening and triage, tailoring trauma‐informed clinical care, and quality improvement including evaluation of workflow and technique modifications or service innovations such as HPV self‐collection.
This initial validation has limitations, including non‐probability online recruitment and a sample restricted to sexually active women, which may limit generalizability. Future research should establish convergent/discriminant validity, determine measurement invariance across key subgroups, examine responsiveness to targeted interventions, and conduct cross‐cultural adaptation. With these steps, the scale can serve as a robust, patient‐centered measure to inform clinical practice and implementation efforts aimed at reducing procedure‐related anxiety and improving participation in preventive gynecologic care.
AUTHOR CONTRIBUTIONS
Hacer Demirtop: Conceptualization, data curation, methodology, formal analysis, software, supervision, visualization, investigation, writing–review and editing. Kerime Derya Beydağ: Conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing–original draft, writing–review and editing. Aysu Yıldız Karaahmet: Conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing–original draft, writing–review and editing.
FUNDING INFORMATION
The authors received no financial support for the research, authorship, and/or publication of this article.
CONFLICT OF INTEREST STATEMENT
The authors declare that they have no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
REFERENCES
- 1. O'Laughlin DJ, Strelow B, Fellows N, et al. Addressing anxiety and fear during the female pelvic examination. J Prim Care Community Health. 2021;12:2150132721992195. doi: 10.1177/2150132721992195 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2. U.S. Department of Veterans Affairs, Health Services Research & Development . Screening pelvic examinations in asymptomatic, average‐risk adult women: Evidence brief. 2025. https://www.hsrd.research.va.gov/publications/management_briefs/ [PubMed]
- 3. Peinado M, Rivas C, Araya AX, et al. Women's critical experiences with the pap smear: a qualitative synthesis. Int J Equity Health. 2023;22:76. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10018556/ [Google Scholar]
- 4. Kinsinger LS. Screening pelvic examinations in asymptomatic, average‐risk adult women (Management eBrief). VA HSR&D; 2025. https://www.hsrd.research.va.gov/publications/management_briefs/ [Google Scholar]
- 5. Guirguis‐Blake JM, Henderson JT, Perdue LA, et al. Screening for gynecologic conditions with pelvic examination. (Evidence Syntheses No. 159). Agency for Healthcare Research and Quality; 2017. https://www.ncbi.nlm.nih.gov/books/NBK442153/ [PubMed] [Google Scholar]
- 6. Yanikkerem E, Özdemir M, Bingol H, Tatar A, Karadeniz G. Women's attitudes and expectations regarding gynaecological examination. Midwifery. 2009;25(5):500‐508. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7. Gustafson LW, Lidegaard Ø, Hansen BT, et al. Validity and reliability of the state‐trait anxiety inventory in women with abnormal cervical screening results. Eur J Obstet Gynecol Reprod Biol. 2020;252:535‐541. [Google Scholar]
- 8. Ilić I, Stojanović N, Grujičić J. Internal consistency and validity of the hospital anxiety and depression scale among women with abnormal pap smears. Women Health. 2021;61(5):451‐462. doi: 10.1080/03630242.2021.1893244 [DOI] [PubMed] [Google Scholar]
- 9. Burnham M, Gilkey MB, Valencia CI, et al. VA patient and staff perspectives on self‐collected HPV testing. Prev Med Rep. 2024;37:102493. doi: 10.1016/j.pmedr.2024.102493 [DOI] [Google Scholar]
- 10. Silver MI, Khan MJ, Rositch AF, Perkins RB, Fuzzell LN. Barriers to cervical cancer screening and satisfaction with self‐collection: a review. Cancers (Basel). 2024;16(7):1342. doi: 10.3390/cancers16071342 [DOI] [Google Scholar]
- 11. Siwe K, Wijma K, Stjernquist M, Wijma B. Validation of the fear of pelvic examination scale (F‐PEXS): measuring students' fear of performing a pelvic examination. J Psychosom Obstet Gynaecol. 2015;36(1):23‐28. doi: 10.3109/0167482X.2014.995461 [DOI] [PubMed] [Google Scholar]
- 12. Seehusen DA, Johnson DR, Earwood JS. Improving women's experience during speculum examinations at routine gynaecological visits: randomized clinical trial. J Am Board Fam Med. 2006;19(4):393‐399. doi: 10.3122/jabfm.19.4.393 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13. Hu L, Bentler PM. Cutoff criteria for fit indexes in covariance structure analysis. Struct Equ Modeling. 1999;6(1):1‐55. doi: 10.1080/10705519909540118 [DOI] [Google Scholar]
- 14. Kline RB. Principles and Practice of Structural Equation Modeling. 4th ed. Guilford Press; 2016. [Google Scholar]
- 15. Terwee CB, Prinsen CAC, Chiarotto A, et al. COSMIN methodology for evaluating the content validity of patient‐reported outcome measures: a Delphi study. Qual Life Res. 2018;27(5):1159‐1170. doi: 10.1007/s11136-018-1829-0 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16. U.S. Preventive Services Task Force . Draft recommendation statement: Cervical cancer screening. 2024. https://www.uspreventiveservicestaskforce.org/uspstf/draft‐recommendation/cervical‐cancer‐screening‐adults‐adolescents
- 17. Arbyn M, Peeters E, Benoy I, et al. Agreement between human papillomavirus testing of self‐collected versus clinician‐collected samples: a meta‐analysis. Int J Cancer. 2022;151(3):481‐487. doi: 10.1002/ijc.34035 [DOI] [Google Scholar]
- 18. Wentzensen N, Massad LS, Clarke MA, et al. Self‐collected vaginal specimens for HPV testing: evidence summary and performance considerations. J Low Genit Tract Dis. 2025;29(2):73‐84. https://journals.lww.com/jlgtd/Fulltext/2025/04000/self_collected_vaginal_specimens_for_hpv_testing_.6.aspx [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19. American College of Obstetricians and Gynecologists . Caring for patients who have experienced trauma. Committee Opinion. 2021. https://www.acog.org/clinical/clinical‐guidance/committee‐opinion/articles/2021/04/caring‐for‐patients‐who‐have‐experienced‐trauma
- 20. Hill DA, Crowell M, Kivlahan C, Szpunar S. Effect of lubricating gel on patient comfort during vaginal speculum insertion: a randomized controlled trial. Obstet Gynecol. 2012;119(2 Pt 1):227‐233. doi: 10.1097/AOG.0b013e318242fdc2 [DOI] [PubMed] [Google Scholar]
- 21. Lin SN, Taylor J, Alperstein S, Hoda R, Holcomb K. Does speculum lubricant affect liquid‐based Papanicolaou test adequacy? Cancer Cytopathol. 2014;122(3):221‐226. doi: 10.1002/cncy.21369 [DOI] [PubMed] [Google Scholar]
- 22. Ilika CP, Ezegwui HU, Eke AC, et al. Effects of speculum lubrication on cervical smears and pain during pap testing: randomized controlled study. PLoS One. 2024;19(10):e0292207. doi: 10.1371/journal.pone.0292207 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23. Mokkink LB, Prinsen CAC, Patrick DL, et al. COSMIN guideline for systematic reviews of patient‐reported outcome measures (updated). Qual Life Res. 2024;33(Supp l):1‐18. doi: 10.1007/s11136-024-03761-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24. Bethlehem J. Selection bias in web surveys. Int Stat Rev. 2010;78(2):161‐188. doi: 10.1111/j.1751-5823.2010.00112.x [DOI] [Google Scholar]
- 25. Putnick DL, Bornstein MH. Measurement invariance conventions and reporting: the state of the art and future directions for psychological research. Dev Rev. 2016;41:71‐90. doi: 10.1016/j.dr.2016.06.004 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26. Sousa V, Rojjanasrirat W. Translation, adaptation, and validation of instruments or questionnaires for use in cross‐cultural health care research: a clear and user‐friendly guideline. J Eval Clin Pract. 2011;17(2):268‐274. doi: 10.1111/j.1365-2753.2010.01434.x [DOI] [PubMed] [Google Scholar]
- 27. Sürücü L, Maslakçı A. Validity and reliability in quantitative research. Bus Manag Stud Inter J. 2020;8(3):2694‐2726. [Google Scholar]
- 28. Tavşancıl E. Measurement of Attitudes and Data Analysis with SPSS. 6th ed. Nobel Academic Publishing; 2019. [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.