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Not yet recruiting NCT06940583

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

No phase Interventional Stress Anxiety Pain Colposcopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR, Podcast.
Who it may be relevant to
Registry conditions: Stress, Anxiety, Pain, Colposcopy. Basic parameters: 25 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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).

Primary outcome measures

  • Perceived Stress Scale [Time frame: Before and after colposcopy at 5 min.]
  • State Anxiety Inventory [Time frame: Before and after colposcopy procedure 5 min.]
  • Visual Analog Scale [Time frame: Before and after colposcopy procedure 5 min.]
Secondary outcome measures (3)
  • Patient Satisfaction Scale [Time frame: 5 minutes after colposcopy procedure]
  • Pulse measurement [Time frame: 5 minutes before and after the colposcopy procedure.]
  • Prosedur duration [Time frame: During the colposcopy procedure (in minutes)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Etlik City Hospital,Department of Gynecology Oncology — Ankara

Identifiers

NCT: NCT06940583 · VR24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗