- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462039
Effect of Virtual Reality on Pain and Anxiety During Pap Smear Testing
The Effect of Virtual Reality Transition on Pain and Anxiety Experienced During Pap Smear Testing
This randomized controlled pretest-posttest experimental study aims to evaluate the effect of virtual reality (VR) on pain and anxiety levels experienced during Pap smear sampling. Although cervical cancer is largely preventable through regular screening, many women avoid Pap smear testing due to anxiety, fear of pain, and discomfort during gynecological examinations. Innovative, non-invasive interventions are needed to improve women's screening experiences and participation rates.
The study will be conducted in a gynecology outpatient clinic with 60 women aged 18-65 years who meet the inclusion criteria and provide informed consent. Participants will be randomly assigned to either the intervention group (VR headset during the procedure) or the control group (standard care). Women in the intervention group will watch a 360° relaxing nature video during the Pap smear procedure. Data will be collected using a Personal Information Form, the State Anxiety Inventory, and the Visual Analog Scale (VAS). The findings may support integrating VR into clinical practice to enhance patient comfort during screening procedures.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study was planned as a randomized controlled, pretest-posttest true experimental design to evaluate the effect of a virtual reality (VR) application on pain and anxiety levels experienced by women during Pap smear sampling. Although cervical cancer is preventable, it remains a significant cause of morbidity and mortality among women worldwide. Despite the availability of regular screening programs, many women are reluctant to undergo Pap smear testing due to factors such as pain, anxiety, and concerns about privacy during gynecological examinations. Therefore, there is a need for innovative and non-invasive methods to reduce negative experiences during the procedure.
The study will be conducted at the Gynecology and Obstetrics Outpatient Clinic of Gazimağusa Yaşam Hospital. The sample will consist of 60 women aged 18-65 years who meet the inclusion criteria and voluntarily agree to participate. Participants will be randomly assigned to either the intervention group (VR headset applied) or the control group (standard care) using a simple randomization method.
Women in the intervention group will watch a 360° relaxing nature video through a virtual reality headset during the Pap smear procedure. The control group will receive the standard clinical procedure. Data will be collected using a Personal Information Form, the State Anxiety Inventory, and the Visual Analog Scale (VAS). Anxiety levels will be assessed before and after the procedure, and pain levels will be evaluated after the procedure.
The findings are expected to demonstrate the effectiveness of virtual reality in reducing pain and anxiety during Pap smear procedures and to contribute to evidence-based practices aimed at increasing women's participation in cervical cancer screening programs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arzu Abiç, PhD
- Phone Number: 05488506060
- Email: arzu.abic@gmail.com
Study Contact Backup
- Name: Buse Güney
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18-65 years
- Scheduled for a Pap smear procedure
- Able to communicate in Turkish
- Able to understand and complete the study questionnaires
- Willing to provide written informed consent
- No visual or hearing impairment preventing the use of a VR headset
Exclusion Criteria:
- History of severe motion sickness or vertigo
- Diagnosed psychiatric disorder affecting anxiety assessment
- Use of anxiolytic or sedative medication within 24 hours prior to the procedure
- Presence of acute pelvic pain or active vaginal infection
- Previous participation in this study
- Any condition preventing safe use of a VR headset
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
Participants will watch a 360° relaxing nature video through a VR headset during the Pap smear procedure.
|
Participants will watch a 360° relaxing nature video through a VR headset during the Pap smear procedure.
|
|
No Intervention: Control Group
Routin nursing care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level during Pap smear procedure
Time Frame: Immediately after completion of the Pap smear procedure (within 5 minutes post-procedure).
|
Pain intensity experienced during the Pap smear procedure will be measured using the Visual Analog Scale (VAS).
The VAS is a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
Immediately after completion of the Pap smear procedure (within 5 minutes post-procedure).
|
|
State anxiety level
Time Frame: Immediately before the procedure and immediately after the procedure.
|
Anxiety level will be assessed using the State Anxiety Inventory before and after the Pap smear procedure.
Higher scores indicate higher anxiety levels.
|
Immediately before the procedure and immediately after the procedure.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETK-00-2025-0190
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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