Clinical trial NCT06718504: The Effect of Virtual Reality Glasses During Endoscopy
Official title: The Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Upper Gastrointestinal System Endoscopy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Gastro-Intestinal Disorder
Keywords: Pain
Anxiety
Comfort
Endoscopy
Virtual Reality Glasses
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: This single-center randomized controlled parallel group study was conducted with 60 patients who underwent upper gastrointestinal endoscopy at the Endoscopy Unit of a training and research hospital in Istanbul. Patients in the virtual reality glasses group (n=30) watched videos of their preferred relaxing nature settings or videos without any violent content during the procedure. Patients in the control group (n=30) received no intervention. Data were collected using the Patient Information Form, Visual Analog Scale (for pain and comfort) and State Anxiety Inventory. Pain, comfort and anxiety levels of patients were assessed five minutes before and five minutes after the procedure.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change on pain intensity as measured by Visual Analog Scale
timeFrame: five minutes before endoscopy and five minutes after endoscopy
Secondary outcomes:
measure: Change on anxiety level as measured by State-Trait Anxiety Inventory
timeFrame: five minutes before endoscopy and five minutes after endoscopy
Other outcomes:
measure: Change on satisfaction level as measured by Visual Analog Scale
timeFrame: five minutes before endoscopy and five minutes after endoscopy
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Elif Gezginci Akpınar, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: