NCT05585749

Brief Summary

In contemporary medicine, endoscopic procedures are often regarded as the gold standard for the diagnosis and treatment of gastrointestinal illnesses due to the essential role they play in these processes. Endoscopy is a minimally invasive procedure that allows direct visualization of the gastrointestinal tract using a flexible, camera-equipped instrument.However, due to their invasive nature, these methods pose certain challenges for both healthcare professionals and patients. In particular, the physical discomfort and pain experienced during the procedure can lead to a negative attitude toward the process in patients, which can indirectly affect the success of the procedure .Despite the fact that a number of studies have examined the impact of virtual reality applications on pain and anxiety during endoscopy, the conclusions remain inconsistent. Moreover, relatively few studies have assessed physiological signs of anxiety. Therefore, uncertainties remain regarding the generalizability of existing findings. The present study aimed to examine the effect of virtual reality application on pain, anxiety, and physiological parameters in patients undergoing endoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

September 22, 2022

Last Update Submit

December 3, 2025

Conditions

Keywords

Virtual RealityAnxietyPainEndoscopy Patients

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain

    1 hours later

  • Anxiety Assessment Scale

    Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.

    1 hours later

  • Physiological Symptoms of Anxiety Follow-up Form

    This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation value.

    1 hours later

Study Arms (2)

Virtual Reality Based Relaxation Program

EXPERIMENTAL

Virtual Reality Based Relaxation Program

Other: Virtual Reality Based Relaxation Program

Control group

NO INTERVENTION

Routine maintenance will be applied.

Interventions

Virtual Reality Based Relaxation Program

Virtual Reality Based Relaxation Program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gülcan Bahçecioğlu Turan, PhD

    Firat University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Virtual Reality Based Relaxation Program
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Virtual Reality Based Relaxation Program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 19, 2022

Study Start

September 5, 2022

Primary Completion

January 30, 2023

Study Completion

June 30, 2023

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations