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

NCT ID: NCT06940583

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Anxiety Pain Colposcopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CONTROL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Podcast

Intervention Type 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).

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.

Group Type EXPERIMENTAL

VR

Intervention Type 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.

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sinem Ceylan

OTHER

Sponsor Role lead

Responsible Party

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Sinem Ceylan

Ankara Medipol University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sinem Ceylan

Role: STUDY_CHAIR

Ankara Medipol University,Turkey

Özgün Ceylan

Role: PRINCIPAL_INVESTIGATOR

Etlik City Hospital,Ankara,Turkey

Vakkas Korkmaz

Role: STUDY_DIRECTOR

Etlik City Hospital,Ankara,Turkey

Gülten Güvenç

Role: STUDY_CHAIR

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

Şahin Kaan Baydemir

Role: STUDY_CHAIR

Etlik City Hospital,Ankara,Turkey

Locations

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Etlik City Hospital,Department of Gynecology Oncology

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Sinem Ceylan, Dr.

Role: CONTACT

05338186689

Özgün Ceylan

Role: CONTACT

Facility Contacts

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Özgün Ceylan

Role: primary

+905372270678

Other Identifiers

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VR24

Identifier Type: -

Identifier Source: org_study_id

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