Clinical trial NCT06940583: Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy
Official title: Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Pain
Colposcopy
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 75
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Before and after colposcopy at 5 min.
measure: State Anxiety Inventory
timeFrame: Before and after colposcopy procedure 5 min.
measure: Visual Analog Scale
timeFrame: Before and after colposcopy procedure 5 min.
Secondary outcomes:
measure: Patient Satisfaction Scale
timeFrame: 5 minutes after colposcopy procedure
measure: Pulse measurement
timeFrame: 5 minutes before and after the colposcopy procedure.
measure: Prosedur duration
timeFrame: During the colposcopy procedure (in minutes)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital,Department of Gynecology Oncology
Study officials:
affiliation: Ankara Medipol University,Turkey
name: Sinem Ceylan
role: STUDY_CHAIR
affiliation: Etlik City Hospital,Ankara,Turkey
name: Özgün Ceylan
role: PRINCIPAL_INVESTIGATOR
affiliation: Etlik City Hospital,Ankara,Turkey
name: Vakkas Korkmaz
role: STUDY_DIRECTOR
affiliation: Turkey Health Science University,Gulhane Nursing Faculty, Ankara,Turkey
name: Gülten Güvenç
role: STUDY_CHAIR
affiliation: Etlik City Hospital,Ankara,Turkey
name: Şahin Kaan Baydemir
role: STUDY_CHAIR
References: