Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction

July 30, 2026 updated by: Derya Şimşekli, Ardahan University

Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction: A Randomized Controlled Trial

Objective: This study aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction.

Methods: This randomized controlled trial will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients scheduled to undergo upper gastrointestinal endoscopy will be enrolled and randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group. Participants in the intervention group will receive a virtual reality application before the endoscopy procedure, whereas participants in the control group will receive standard care. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, and patient satisfaction will be assessed immediately after the procedure.

Expected Results: It is anticipated that the virtual reality intervention will reduce preprocedural anxiety, improve psychological readiness, and increase postprocedural satisfaction compared with standard care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Upper gastrointestinal endoscopy is one of the most frequently performed diagnostic procedures for evaluating disorders of the upper gastrointestinal tract. Although it is generally considered safe, many patients experience considerable anxiety before the procedure. High levels of preprocedural anxiety may negatively affect psychological readiness, reduce patient cooperation, impair the overall procedural experience, and decrease satisfaction with care. Therefore, effective non-pharmacological interventions that improve the patient's psychological state before endoscopy are needed.

Virtual reality (VR) is an immersive technology that provides visual and auditory stimulation, allowing individuals to become engaged in a relaxing virtual environment and divert their attention from stressful situations. Previous studies have demonstrated that virtual reality can reduce anxiety, pain, and physiological stress during various medical procedures. However, evidence regarding the effectiveness of virtual reality when applied before upper gastrointestinal endoscopy, particularly its effects on psychological readiness and postprocedural satisfaction, remains limited.

This randomized controlled trial aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction. The study will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group using block randomization.

Participants in the intervention group will receive a virtual reality application before the endoscopy procedure in addition to standard care. Participants in the control group will receive standard preprocedural care only. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, while postprocedural satisfaction will be assessed immediately after completion of the endoscopy.

The findings of this study are expected to provide evidence regarding the effectiveness of virtual reality as a simple, non-invasive, and low-cost intervention for reducing preprocedural anxiety, improving patients' psychological readiness for upper gastrointestinal endoscopy, and enhancing satisfaction with the procedure. The results may contribute to the development of evidence-based nursing interventions and improve patient-centered care in endoscopy units.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Scheduled to undergo upper gastrointestinal endoscopy
  • Able to understand and communicate in Turkish
  • Willing to participate in the study
  • Providing written informed consent

Exclusion Criteria:

  • Presence of a diagnosed psychiatric or neurological disorder that may interfere with participation
  • Presence of a visual, hearing, head, face, or eye condition that prevents the use of a virtual reality headset
  • History of severe vertigo, motion sickness, or balance disorder
  • Development of severe dizziness, nausea, eye strain, or discomfort during the virtual reality intervention
  • Refusal to participate or withdrawal from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Participants will receive a virtual reality intervention before upper gastrointestinal endoscopy in addition to standard preprocedural care. The virtual reality application will be administered before the endoscopy procedure using a virtual reality headset.
Device: Virtual Reality
Participants will receive the institution's standard preprocedural care before upper gastrointestinal endoscopy without the virtual reality intervention.
Active Comparator: Standard Care Group
Participants will receive a virtual reality intervention using a virtual reality headset before upper gastrointestinal endoscopy. The intervention is designed to reduce preprocedural anxiety, improve psychological readiness, and enhance patient satisfaction.
Other: Standard Preprocedural Care
Participants will receive the institution's routine preprocedural care before upper gastrointestinal endoscopy without virtual reality.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preprocedural Anxiety
Time Frame: Immediately before upper gastrointestinal endoscopy
Preprocedural anxiety will be assessed using the State Anxiety Inventory (STAI-I). The STAI-I consists of 20 items scored on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
Immediately before upper gastrointestinal endoscopy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychological Readiness
Time Frame: Immediately before upper gastrointestinal endoscopy
Psychological readiness will be assessed using a single-item question asking participants how psychologically prepared they feel for the endoscopy procedure. Responses are scored from 1 (not at all prepared) to 5 (very well prepared), with higher scores indicating greater psychological readiness.
Immediately before upper gastrointestinal endoscopy
Postprocedural Satisfaction
Time Frame: Immediately after upper gastrointestinal endoscopy
Postprocedural satisfaction will be assessed using a single-item satisfaction question scored from 1 (not satisfied at all) to 5 (very satisfied). Higher scores indicate greater patient satisfaction with the endoscopy procedure.
Immediately after upper gastrointestinal endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ardahan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gümüşhane Universıty

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: DERYA ŞİMŞEKLİ, Dr., Ardahan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ArdahanU-Simsekli-DS-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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