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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：ÇİLER ÇOKAN DÖNMEZ, PhD
- 電話番号：+903443001000
- メール：cilerdonmez@hotmail.com
研究場所
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Adana
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Adana、Adana、トルコ（Türkiye）、01250
- 募集
- Çukurova University Hospital
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コンタクト：
- Cukurova Üniversitesi Hastanesi Balcalı Hastanesi
- 電話番号：03223386060
- メール：ghanim.khatib@gmail.com
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副調査官：
- Esra Ünal, PhD
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副調査官：
- Ganim Khatip, Medical Doctor Prof
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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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研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Primary Outcome Measure
時間枠：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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Secondary Outcome Measure
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年2月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年10月1日
試験登録日
最初に提出
2026年6月10日
QC基準を満たした最初の提出物
2026年6月10日
最初の投稿 (実際)
2026年6月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月16日
QC基準を満たした最後の更新が送信されました
2026年6月10日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- E-58565088-100-275994
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Due to data privacy requirements, individual patient information is not disclosed.
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