The Effect of Virtual Reality-Based Intervention on Anxiety, Stress, and Pain in Women Undergoing Colposcopy: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality-Based Intervention, 30 control group.
- Who it may be relevant to
- Registry conditions: Virtual Reality-Based Intervention, Anxiety, Stress, Colposcopy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Virtual Reality-Based Intervention
During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses - Other 30 control group
Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.
Primary outcome measures
- Primary Outcome Measure [Time frame: 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. [Time frame: 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 outcome measures (1)
- Secondary Outcome Measure [Time frame: 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.]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Çukurova University Hospital — Adana
Publications
- 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., Rei
Identifiers
NCT: NCT07650422 · E-58565088-100-275994