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

NCT06940583 | Not Yet Recruiting

• 1 other identifier: VR24
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress; Anxiety; Pain; Colposcopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient Satisfaction Scale

  5 minutes after colposcopy procedure

• Pulse measurement

  5 minutes before and after the colposcopy procedure.

• Prosedur duration

  During the colposcopy procedure (in minutes)

Study Arms (3)

CONTROL

NO INTERVENTION

Participants in this group will not receive any distraction during colposcopy. Only standard colposcopy information will be given.

Podcast

EXPERIMENTAL

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

VR

EXPERIMENTAL

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

Interventions

VR OTHER

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.

VR

Podcast OTHER

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).

Podcast

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinem Ceylan: lead

Study Sites (1)

Etlik City Hospital,Department of Gynecology Oncology

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sinem Ceylan

  Ankara Medipol University,Turkey

  STUDY CHAIR

• Özgün Ceylan

  Etlik City Hospital,Ankara,Turkey

  PRINCIPAL INVESTIGATOR

• Vakkas Korkmaz

  Etlik City Hospital,Ankara,Turkey

  STUDY DIRECTOR

• Gülten Güvenç

  Turkey Health Science University,Gulhane Nursing Faculty, Ankara,Turkey

  STUDY CHAIR

• Şahin Kaan Baydemir

  Etlik City Hospital,Ankara,Turkey

  STUDY CHAIR

Central Study Contacts

Sinem Ceylan, Dr.

CONTACT

05338186689; ceylansinem1@gmail.com

Özgün Ceylan

CONTACT

ozguncyln@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ankara Medipol University

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 23, 2025
• Study Start: April 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)