The Effect of Virtual Reality Glasses During Endoscopy

NCT06718504 | Completed

• 1 other identifier: 167
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Upper gastrointestinal endoscopy is an invasive procedure used to diagnose and treat pathologies in the gastrointestinal mucosa. Since it is an invasive procedure, it can cause anxiety in patients before and pain during the procedure. Virtual reality glasses are an effective method used to reduce the pain and anxiety levels of patients during painful procedures. This study aimed to evaluate the effects of virtual reality glasses on pain, anxiety, and comfort in patients undergoing upper gastrointestinal endoscopy without sedation.

Conditions

Pain; Anxiety; Gastro-Intestinal Disorder

Keywords

Pain; Anxiety; Comfort; Endoscopy; Virtual Reality Glasses

Outcome Measures

Primary Outcomes (1)

• Change on pain intensity as measured by Visual Analog Scale

  The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.

  five minutes before endoscopy and five minutes after endoscopy

Secondary Outcomes (1)

• Change on anxiety level as measured by State-Trait Anxiety Inventory

  five minutes before endoscopy and five minutes after endoscopy

Other Outcomes (1)

• Change on satisfaction level as measured by Visual Analog Scale

  five minutes before endoscopy and five minutes after endoscopy

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

During the procedure, patients in the intervention group watched videos of their choice, either in a relaxing natural setting or without any violent content, using virtual reality glasses.

Device: Virtual Reality Glasses

Control Group

NO INTERVENTION

No intervention was applied to the patients in the control group.

Interventions

Virtual Reality Glasses DEVICE

Virtual reality is a method that can be used to distract and prepare patients for medical procedures. Virtual reality is a computer-generated environment where three-dimensional interaction is possible. It is an advanced technology that allows an individual to move into a virtual environment and focus their attention on other thoughts, allowing them to pay less attention to pain and anxiety. In this study, the virtual reality glasses were put on for the intervention group five minutes before the procedure began and were kept on until the procedure was completed. The virtual reality glasses showed the patient-selected images of a relaxing nature setting or images without any violent content.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have an upper gastrointestinal endoscopy for the first time
• To be performed an upper GI endoscopy without sedation
• To be between the ages of 18-75
• To be willing to participate in research

You may not qualify if:

• To use analgesic or anesthetic drugs before or during the procedure
• To use antidepressants, anxiolytic and sedative drugs
• To have communication difficulties and mental disability

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Digestive System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Elif Gezginci Akpınar, Assoc Prof

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: This study is a single-center parallel-group randomized controlled clinical trial. Participants who met the inclusion criteria for the study were divided into two equal groups: the intervention group (n=30) and the control group (n=30). according to the computer-based randomization table.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: July 31, 2024
• Primary Completion: October 10, 2024
• Study Completion: December 2, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)