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Completed

NCT Number: NCT06718504

The Effect of Virtual Reality Glasses During Endoscopy

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Digestive System Diseases Gastro-Intestinal Disorder Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change on pain intensity as measured by Visual Analog Scale

    Time frame: five minutes before endoscopy and five minutes after endoscopy

    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.

Secondary outcomes

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

    Time frame: five minutes before endoscopy and five minutes after endoscopy

    The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale in used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.

Other outcomes

  1. Change on satisfaction level as measured by Visual Analog Scale

    Time frame: five minutes before endoscopy and five minutes after endoscopy

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

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Upper Gastrointestinal System Endoscopy: Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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