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Not yet recruiting NCT07745959

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

No phase Interventional Upper Gastrointestinal Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality, Standard Preprocedural Care.
Who it may be relevant to
Registry conditions: Upper Gastrointestinal Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Device Virtual Reality
    Participants will receive the institution's standard preprocedural care before upper gastrointestinal endoscopy without the virtual reality intervention.
  • Other Standard Preprocedural Care
    Participants will receive the institution's routine preprocedural care before upper gastrointestinal endoscopy without virtual reality.

Primary outcome measures

  • Preprocedural Anxiety [Time frame: Immediately before upper gastrointestinal endoscopy]
Secondary outcome measures (2)
  • Psychological Readiness [Time frame: Immediately before upper gastrointestinal endoscopy]
  • Postprocedural Satisfaction [Time frame: Immediately after upper gastrointestinal endoscopy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Atatürk University Research Hospital — Erzurum

Identifiers

NCT: NCT07745959 · ArdahanU-Simsekli-DS-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗