The Effect of Virtual Reality-Based Intervention on Anxiety, Stress, and Pain in Women Undergoing Colposcopy: A Randomized Controlled Trial

NCT07650422 | Recruiting

• 1 other identifier: E-58565088-100-275994
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Virtual Reality-Based Intervention; Anxiety; Stress; Colposcopy; Women

Keywords

Women; Colposcopy; Virtual Reality-Based Intervention; Anxiety; Stress; Pain

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Measure

  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

  From before the colposcopy procedure begins until after it is completed

• In this study, anxiety (DSKE-KF), perceived stress (PSS-10), and pain (VAS) were identified as co-primary outcome measures.

  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.

  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

Secondary Outcomes (1)

• Secondary Outcome Measure

  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.

Study Arms (2)

30 control group

ACTIVE COMPARATOR

The control group will receive standard care.No intervention will be performed on the control group.

Other: 30 control group

30 Intervention group

EXPERIMENTAL

During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses

Other: Virtual Reality-Based Intervention

Interventions

Virtual Reality-Based Intervention OTHER

During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses

30 Intervention group

30 control group OTHER

Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.

30 control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Osmaniye Korkut Ata University: lead

Study Sites (1)

Çukurova University Hospital

Adana, Adana, 01250, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ÇİLER ÇOKAN DÖNMEZ, PhD

CONTACT

+903443001000; cilerdonmez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinding: The study will be conducted as evaluator-blind (single-blind). The researcher collecting data and performing measurements will not know which group the participants are in. The virtual reality application will be administered by a staff member who is not part of the research team and is not involved in the data collection process.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: This study is a single-center, two-group (1:1), randomized controlled, assessor-blinded experimental study designed to evaluate the effect of a virtual reality (VR)-based intervention on anxiety, perceived stress, and pain in women undergoing colposcopy. The intervention group will receive VR during colposcopy, while the control group will receive standard care.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)