Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-01 @ 4:12 PM
Study NCT ID:
NCT07145203
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2025-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Patients Undergoing Colonoscopy
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effect of Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR/RCT
Brief Summary:
The goal of this randomized controlled trial was to investigate the effect of Virtual Reality (VR) on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy. The study aimed to determine the efficacy of VR as a non-pharmacological intervention to improve the patient experience during the procedure.
The main research hypotheses are:
H01: There will be no significant difference in anxiety levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H02: There will be no significant difference in perceived stress levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H03: There will be no significant difference in pain levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H04: There will be no significant difference in satisfaction levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
Participants will:
Receive either a VR intervention or standard care during their colonoscopy. Wear a VR headset for 15-30 minutes, immersing themselves in a natural environment with relaxing music and nature sounds.
Complete assessments of anxiety, stress, pain, and satisfaction before and after the procedure using validated questionnaires.
The main research hypotheses are:
H01: There will be no significant difference in anxiety levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H02: There will be no significant difference in perceived stress levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H03: There will be no significant difference in pain levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
H04: There will be no significant difference in satisfaction levels between patients who receive immersive VR during colonoscopy and those who receive standard care.
Participants will:
Receive either a VR intervention or standard care during their colonoscopy. Wear a VR headset for 15-30 minutes, immersing themselves in a natural environment with relaxing music and nature sounds.
Complete assessments of anxiety, stress, pain, and satisfaction before and after the procedure using validated questionnaires.
Detailed Description:
Title: Effect of Virtual Reality on Anxiety, Stress, Pain, and Patient Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial
Background: Colonoscopy is a common diagnostic and therapeutic procedure for gastrointestinal disorders but often causes anxiety, stress, and pain, which can complicate the procedure and increase sedative use. Virtual reality (VR) technology offers immersive, multi-sensory environments that may reduce these negative psychological and physical responses. This study aims to evaluate the effect of VR on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy.
Methods: A randomized controlled trial will be conducted at the Endoscopy Unit of Rafidia Surgical Hospital in Nablus, Palestine. A total of 150 patients scheduled for colonoscopy will be randomly assigned to either the VR group (n=75) or the control group (n=75). The VR group will wear head-mounted VR devices for 15 to 30 minutes during the procedure, choosing from natural environments such as tropical beaches, forests, or snowy landscapes accompanied by relaxing music and nature sounds. Data on anxiety, stress, pain, and satisfaction will be collected through questionnaires administered by the researcher. The study duration is three months.
Background: Colonoscopy is a common diagnostic and therapeutic procedure for gastrointestinal disorders but often causes anxiety, stress, and pain, which can complicate the procedure and increase sedative use. Virtual reality (VR) technology offers immersive, multi-sensory environments that may reduce these negative psychological and physical responses. This study aims to evaluate the effect of VR on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy.
Methods: A randomized controlled trial will be conducted at the Endoscopy Unit of Rafidia Surgical Hospital in Nablus, Palestine. A total of 150 patients scheduled for colonoscopy will be randomly assigned to either the VR group (n=75) or the control group (n=75). The VR group will wear head-mounted VR devices for 15 to 30 minutes during the procedure, choosing from natural environments such as tropical beaches, forests, or snowy landscapes accompanied by relaxing music and nature sounds. Data on anxiety, stress, pain, and satisfaction will be collected through questionnaires administered by the researcher. The study duration is three months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: