An interventional study of Virtual Reality-Based Intervention and 30 control group in Virtual Reality-Based Intervention, Anxiety and Stress, sponsored by Osmaniye Korkut Ata University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Osmaniye Korkut Ata University · Not applicable, Interventional, and Supportive care
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Osmaniye Korkut Ata University is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 -
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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will receive standard care.No intervention will be performed on the control group.
Other: 30 control group
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
During the colposcopy, the intervention group will be provided with a nature-themed, relaxing virtual environment experience via SG glasses
Participants in the control group will not receive any additional interventions beyond the standard care provided at the colposcopy unit.
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
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.
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.
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 Measure
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.
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.
Plan to share: No — Due to data privacy requirements, individual patient information is not disclosed.
Started Feb 2026 (actual). Primary completion is estimated for Sep 2026, 7 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 7 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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Osmaniye Korkut Ata University