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Clinical Trials in Turkey / NCT07853300
Enrolling by invitation Not applicable

The Effect of Virtual Reality Application on Pain, Anxiety, and Embarrassment During Colonoscopy

NCT07853300 · tracked via the Priya Life Science Turkey tracker
Sponsor
Kocaeli University
Phase
Not applicable
Started
2025-12-12
Last updated
2026-10-01

Condition(s) studied

Colonoscopy

Investigational drug(s) / intervention(s)

Virtual Reality (VR) Intervention Group

Virtual Reality (VR) Intervention Group: The intervention consists of a virtual reality (VR) application delivered via a head-mounted display integrated with an Android-based smartphone. Participants assigned to the intervention group will view immersive audiovisual content beginning prior to the colonoscopy procedure and continuing throughout the procedure. The VR application is designed to provide distraction and reduce procedural pain, anxiety, and embarrassment. No sedation will be administered. Standard monitoring and colonoscopy procedures will be conducted in accordance with institutional protocols.

Study summary

This study will be conducted to determine the effects of virtual reality (VR) intervention applied during colonoscopy performed without sedation on pain, anxiety, embarrassment, and physiological parameters.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age between 18 and 65 years * Scheduled for colonoscopy at the participating endoscopy unit * First-time colonoscopy * Colonoscopy performed without sedation * Voluntary participation with signed informed consent Exclusion Criteria: * Hearing or visual impairment * Communication difficulties * History of psychiatric disorders * Chronic pain complaints * Dementia * Previous abdominal or pelvic surgery * Use of anxiolytic or analgesic medications within the last 72 hours

Primary outcome measure(s)

  • Pain Intensity (VAS, Post-Procedure) — Immediately after colonoscopy procedure
    Pain experienced during colonoscopy will be measured immediately after the procedure using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
  • Embarrassment (Colonoscopy Shame Scale, Pre-Procedure) — 15 minutes before colonoscopy procedure
    Participants' embarrassment prior to the procedure will be measured using the Colonoscopy Shame Scale, with scores ranging from 15 (lowest embarrassment) to 60 (highest embarrassment).
  • Embarrassment (VAS, Pre-Procedure) — 15 minutes before colonoscopy procedure
    Embarrassment prior to the procedure will also be measured using a Visual Analog Scale (VAS), ranging from 0 (no embarrassment) to 10 (maximum embarrassment).
  • Embarrassment (VAS, Post-Procedure) — Immediately after colonoscopy procedure
    Embarrassment experienced during the procedure will be assessed again using VAS, ranging from 0 to 10.
  • State Anxiety (STAI-S, Pre-Procedure) — 15 minutes before colonoscopy procedure
    Participants' situational (state) anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S), with scores ranging from 20 (lowest anxiety) to 80 (highest anxiety).
  • Trait Anxiety (STAI-T, Pre-Procedure) — 15 minutes before colonoscopy procedure
    Participants' baseline/general (trait) anxiety will be assessed using the Trait Anxiety subscale of STAI-T, with scores ranging from 20 to 80.
  • State Anxiety (STAI-S, Post-Procedure) — Immediately after colonoscopy procedure
    Participants' situational (state) anxiety will be reassessed immediately after the procedure using the State Anxiety subscale of STAI-S, scores ranging from 20 to 80.
  • Anxiety (VAS, Pre-Procedure) — 15 minutes before colonoscopy procedure
    Participants' anxiety prior to the procedure will also be measured using a Visual Analog Scale (VAS), ranging from 0 (no anxiety) to 10 (maximum anxiety).
  • Anxiety (VAS, Post-Procedure) — Immediately after colonoscopy procedure
    Participants' anxiety during the procedure will be measured again using VAS, ranging from 0 to 10.

Trial sites (1)

FacilityCityRegionStatus
Kocaeli University Hospital Kocaeli İzmit

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07853300 on ClinicalTrials.gov ↗ ← All trials in Turkey