The Effect of Virtual Reality-Based Intervention on Anxiety, Stress, and Pain in Women Undergoing Colposcopy: A Randomized Controlled Trial (Colposcopy)
2026年6月10日 更新者：Çiler ÇOKAN DÖNMEZ、Osmaniye Korkut Ata University
Due to its invasive nature, the colposcopy procedure can cause high levels of anxiety, stress, pain, and nausea in women.
The uncertainty surrounding the condition to be diagnosed, combined with the discomfort caused by the procedure itself, creates significant psychological stress in women and can negatively impact their compliance with diagnosis and treatment.
Therefore, it is believed that applying Virtual Reality (VR) technology-one of the distraction techniques-as a non-pharmacological method for women undergoing colposcopy could be effective in reducing pain and anxiety by diverting their cognitive attention away from the procedure's negative stimuli.
Although there are many studies in the literature using VR technology, no study has been found that examines the effect of VR-based interventions on anxiety, stress, and pain levels in women undergoing colposcopy.
Therefore, this study will be one of the first randomized controlled trials to examine the multidimensional effects of virtual reality (anxiety, stress, pain) in women undergoing colposcopy.
The findings will contribute to the widespread adoption of non-pharmacological nursing interventions in clinical practice.
The aim of this study is to comprehensively evaluate the effect of a virtual reality (VR)-based intervention on anxiety, stress, and pain levels in women undergoing colposcopy and to determine its efficacy compared to standard care.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：ÇİLER ÇOKAN DÖNMEZ, PhD
- 电话号码：+903443001000
- 邮箱：cilerdonmez@hotmail.com
学习地点
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Adana
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Adana、Adana、土耳其（türkiye）、01250
- 招聘中
- Çukurova University Hospital
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接触：
- Cukurova Üniversitesi Hastanesi Balcalı Hastanesi
- 电话号码：03223386060
- 邮箱：ghanim.khatib@gmail.com
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副研究员：
- Esra Ünal, PhD
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副研究员：
- Ganim Khatip, Medical Doctor Prof
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Be 18 years of age or older, Have colposcopy scheduled due to a cervical cytology result of LSIL, HSIL, ASC-US, or HPV positivity, Be able to read and understand Turkish, Provide voluntary written informed consent -
Exclusion Criteria:
Diagnosis of a mental disorder Severe visual impairment, claustrophobia, cognitive impairment History of severe motion sickness (cybersickness) associated with virtual reality use Use of anxiolytic/analgesic medication prior to the procedure Individuals with severe cognitive impairment or communication difficulties
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学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：30 control group
The control group will receive standard care.No intervention will be performed on the control group.
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Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.
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实验性的：30 Intervention group
During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses
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During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary Outcome Measure
大体时间：From before the colposcopy procedure begins until after it is completed
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The Perceived Stress Scale consists of 10 items on a 5-point Likert scale and two dimensions.
In our study, we used the 10-item version of the Perceived Stress Scale.
Scores on the Perceived Stress Scale range from 0 to 40.
A high score on the scale indicates a high level of stress
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From before the colposcopy procedure begins until after it is completed
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In this study, anxiety (DSKE-KF), perceived stress (PSS-10), and pain (VAS) were identified as co-primary outcome measures.
大体时间：The virtual reality headset application will be launched immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finish
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The State-Trait Anxiety Inventory (STAI), developed by Spielberger and colleagues in 1970 and adapted to the Turkish population by Öner and Le Compte in 1985, was revised by Zsido et al. (2020) to create a short form of the inventory by reducing the number of items.
The short form is a 4-point Likert-type inventory consisting of a total of 10 items-5 for state anxiety and 5 for trait anxiety (Zsido et al., 2020; Öner and Le Compte, 1983).
Individuals scoring 10 or higher on the DKE-KF and 14 or higher on the SKE-KF are considered clinically anxious.
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The virtual reality headset application will be launched immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finish
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Secondary Outcome Measure
大体时间：The SG application will be initiated immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finished.
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The Visual Analog Scale (VAS) is a safe, easy-to-use measurement tool developed to determine the intensity of an individual's pain.
The VAS consists of a 10-centimeter line with subjective descriptive labels at each end of the scale (0 cm = no pain and 10 cm = unbearable pain).
The individual marks the point on this 10-cm line that corresponds to their own pain level.
A low score on the VAS indicates that the individual's pain intensity is low or mild, while a high score indicates that the pain intensity is high or severe.
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The SG application will be initiated immediately before the procedure begins, once the participant has been seated in the colposcopy chair and the preparation process has been completed, and will continue until the procedure is finished.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 1. Baradwan, S., Alshahrani, M. S., AlSghan, R., Alyafi, M., Elsayed, R. E., Abdel-Hakam, F. A. A. M., ... & Badran, H. (2024). The effect of virtual reality on pain and anxiety management during outpatient hysteroscopy: a systematic review and meta-analysis of randomized controlled trials. Archives of Gynecology and Obstetrics, 309(5), 1267-1280. DOI: 10.1007/s00404-023-07319-8 2. Dascal, J., Reid, M., IsHak, W. W., Spiegel, B., & Tanner, V. (2017). Virtual reality and medical inpatients: a systematic review of randomized, controlled trials. Innovations in clinical neuroscience, 14(1-2), 14-21. PMC (Tam Metin): https://pmc.ncbi.nlm.nih.gov/articles/PMC5373791/ 3. Deo, N., Khan, K. S., Mak, J., Allotey, J., Gonzalez Carreras, F. J., Fusari, G., & Benn, J. (2020). Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 127(11), 1361-1370. DOI: 10.1111/1471-0528.16377 4. Hecken, J. M., Halagiera, P., Rehman, S., Tempfer, C. B., & Rezniczek, G. A. (2021). Virtual Reality for Anxiety Reduction in Women Undergoing Colposcopy: A Randomized Controlled Trial. The Journal of Minimally Invasive Gynecology, 28(8), 1445-1451. DOI: 10.1016/j.jmig.2021.01.016 5. Öner, N., & Le Compte, A. (1983). Durumluk-Sürekli Kaygı Envanteri El Kitabı. Boğaziçi Üniversitesi Yayınları. 6. Cohen, S. Kamarck, T. ve Mermelstein, R. (1983). A global measure of perceived stress. Journal Of Health And Social Behavior, 85-396. 7. Eskin, M. Harlak, H. Demirkıran, F. ve Dereboy, Ç. (2013). Algılanan Stres Ölçeğinin Türkçeye Uyarlanması. New Symposium Journal, 51(1). 8. Wewers, M. E., Lowe, N. K. (1990). A critical review of visual analogue scales in the measurement of clinical phenomena. Research in Nursing & Health 13, 227-236. 9. Larroy, C. (2002). Comparing visual-analog and numeric scales for assessing menstrual pain. Behavioral Medicine, 27(4), 179-181. 10. Pelazas-Hernández, J. A., Varillas-Delgado, D., G
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年2月1日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年10月1日
研究注册日期
首次提交
2026年6月10日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月10日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- E-58565088-100-275994
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Due to data privacy requirements, individual patient information is not disclosed.
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研究美国 FDA 监管的设备产品
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