Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy

Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy: A Randomized Controlled Trial

This study wants to see if two things-virtual reality (VR) and podcasts-can help women feel better during a medical test called colposcopy. The study looks at stress, anxiety, pain, and heartbeat. It also checks if women are happy with the test and how long the test takes.

There are three groups: one uses VR, one listens to a podcast, and one gets no extra help.

The study will include 75 women in Turkey. All women are 25 to 65 years old and need to have a colposcopy.

Some women cannot join the study-for example, if they are pregnant, cannot see or hear well, or take strong medicine for pain or stress.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Stress; Anxiety; Colposcopy
• Intervention / Treatment: Other: Podcast; Other: VR

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sinem Ceylan, Dr.; Phone Number: 05338186689; Email: ceylansinem1@gmail.com
• Study Contact Backup: Name: Özgün Ceylan; Email: ozguncyln@hotmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Etlik City Hospital,Department of Gynecology Oncology
    • Contact: Özgün Ceylan; Phone Number: +905372270678; Email: ozguncyln@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients scheduled for colposcopy procedure due to suspicion of cervical squamous intraepithelial lesions.
• Individuals who agree to sign the informed consent form and are willing to participate after being informed about the procedure.
• Individuals who are deemed suitable for the colposcopy procedure and whose health status does not constitute an obstacle to perform this procedure (no visual or hearing impairment).
• Volunteers who speak Turkish at a level to understand the methods and questionnaires used in the study.

Exclusion Criteria:

• Those with claustrophobia, epilepsy, or any other neurological or psychological disorder that may cause discomfort when using the VR headset.
• Individuals with hearing loss that affects their ability to hear podcast content.
• Individuals with vision loss that affects their ability to see VR content.
• Individuals who have previously experienced discomfort while using VR or are unable to adapt to VR
• Individuals who are not suitable for the colposcopy procedure or have a serious health condition that may affect the procedure
• Individuals who are pregnant.
• Individuals with language barriers who may have difficulty understanding the study procedures or distractions.
• Individuals with regular use of sedative or pain medication that may affect stress or pain management during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL; Participants in this group will not receive any distraction during colposcopy. Only standard colposcopy information will be given.
Experimental: Podcast; Participants will listen to a podcast of relaxing or informative content for 5 minutes before and during colposcopy. Content is based on individual preferences	Other: Podcast; Participants will listen to a podcast of relaxing or informative content for 5 minutes before and 5 minutes during colposcopy. The content will be selected according to individual preferences (e.g. storytelling, humorous content or educational content).
Experimental: VR; Participants will view a relaxing virtual environment (e.g. nature landscapes, lightly animated themes) for 5 minutes prior to the colposcopy procedure and during the colposcopy wearing a VR headset.	Other: VR; Participants will view a relaxing virtual environment (e.g. nature landscapes, lightly animated themes) for 5 minutes prior to the colposcopy procedure and during the colposcopy wearing a VR headset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	Developed by Cohen, Kamarck and Mermelstein (20) in 1983. PSS was first developed as a 14-item scale and has two other forms, 10 and 4 items. The scale was adapted to Turkish by Eskin et al. PSS was developed to measure the level of stress an individual perceives certain situations as. Participants evaluate the items on a 5-point Likert-type scale.	Before and after colposcopy at 5 min.
State Anxiety Inventory	This scale, developed by Spielberger and his colleagues, consists of two subscales, trait and state, each consisting of 20 questions. The state anxiety scale measures how an individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how an individual feels regardless of the situation and conditions they are in. The score obtained from the reversed statements is subtracted from the score obtained from the direct statements, and 50 is added to the resulting number for the state anxiety scale and 35 for the trait anxiety scale. The scores obtained from both scales vary between 20-80. As the score obtained from the scale increases, it is evaluated that the person's anxiety level is also high. The adaptation of the scale to Turkish, its validity and reliability study were conducted by Öner and Le Compt	Before and after colposcopy procedure 5 min.
Visual Analog Scale	The most commonly used and simplest scale. The scale includes numbers between 0-10, where "0" represents no pain and "10" represents the most severe pain. It is an easy-to-understand scale.	Before and after colposcopy procedure 5 min.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Scale	"Would you rate your overall satisfaction during the colposcopy procedure on a scale of 0 to 10?" will be asked (0: Not satisfied at all - 10: Very satisfied)	5 minutes after colposcopy procedure
Pulse measurement		5 minutes before and after the colposcopy procedure.
Prosedur duration		During the colposcopy procedure (in minutes)

Collaborators and Investigators

• Sponsor: Sinem Ceylan
• Investigators: Study Chair: Sinem Ceylan, Ankara Medipol University,Turkey; Principal Investigator: Özgün Ceylan, Etlik City Hospital,Ankara,Turkey; Study Director: Vakkas Korkmaz, Etlik City Hospital,Ankara,Turkey; Study Chair: Gülten Güvenç, Turkey Health Science University,Gulhane Nursing Faculty, Ankara,Turkey; Study Chair: Şahin Kaan Baydemir, Etlik City Hospital,Ankara,Turkey

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: VR24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No