The Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy
NCT ID: NCT06159829
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-06-22
2022-12-30
Brief Summary
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Design: A single-centre, parallel-group, randomised control trial. Methods: The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution. During the upper endoscopy procedure, patients in the intervention group watched a video of natural scenery through virtual reality goggles. The study outcomes were anxiety and pain.
Detailed Description
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Although upper GI tract endoscopy is an important interventional procedure used in the diagnosis of diseases, it causes patients discomfort and anxiety. Different studies have indicated that 5.5%-48.3% of individuals undergoing upper GI tract endoscopy experience severe anxiety, 15.6%-51.6% experience moderate anxiety, and 78.9% experience mild anxiety. In addition, symptoms such as gagging, nausea, abdominal bloating, and pain can be seen during the endoscopy procedure. Anxiety and pain may affect a patient's compliance and tolerance of the procedure, resulting in the procedure being unnecessarily prolonged and potentially increasing the incidence of complications.
Intravenous sedative and analgesic agents are frequently used during endoscopic procedures. However, sedative agents may cause complications such as phlebitis, hypoxemia, airway obstruction, hypoventilation, hypotension, arrhythmia, and aspiration. Especially in short procedures such as upper GI tract endoscopy, sedation-free endoscopy was introduced both to prevent adverse effects and reduce costs. In addition, some patients do not want to receive sedation due to concerns such as loss of control, allergies, cardiac arrest, and inability to wake up. In such cases, non-pharmacological interventions can be used to increase the patient's comfort, compliance with the procedure, and tolerance in sedation-free upper endoscopies. One of these interventions is Virtual reality (VR). In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping.
The aim of our study was to evaluate the effect of VR on anxiety and pain in patients undergoing upper endoscopy without sedation. This study will help fill the literature gap and guide future research.
METHODS Trial design, participants and setting A single-centre, randomised controlled study was conducted in accordance with the CONSORT guideline. The population of the study comprised patients presenting to a city hospital in the Central Anatolia region of Turkey between June 22 and December 30, 2022 for upper endoscopy without anesthesia. The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution.
Sampling criteria
Patients meeting the following criteria were eligible for inclusion:
* Not using analgesics before the procedure,
* Not using anticoagulants within the last 24 hours,
* Having no vision or hearing problems
* Not receiving sedation
* Having no cognitive or psychiatric disorder that may affect understanding and communication Data collection Intervention Experimental protocol In addition to the standard protocol, patients in the intervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure. Before the procedure, the patients put on the VR goggles and started watching a video titled "4K Video Ultra HD - Breathtaking Sardinia" downloaded from youtube.com. They continued to watch the video throughout the endoscopy procedure, which lasted approximately 5 to 10 minutes. In both groups, levels of pain, state anxiety, and trait anxiety were measured and recorded before the procedure. After the procedure, the patients' pain levels and state anxiety levels during and after the procedure were assessed.
Standard protocol Patients in the control group underwent upper endoscopy following the standard protocol. In this protocol, written consent is obtained from the patient before the procedure and the patient is brought to the procedure room. The patient is asked about the use of anticoagulant agents, lidocaine spray is applied to the mouth to inhibit the gag reflex, and the mouthpiece is placed. The patient is placed in left lateral position for endoscopy, with left leg extended and right leg flexed towards the abdomen. The endoscopy procedure is then performed.
Data collection tools Data were collected using a sociodemographic and clinical information form, the Visual Analog Scale, and the State and Trait Anxiety Inventory.
Data analysis The data were analyzed using the free trial version of SPSS Statistics (Statistical Package for Social Sciences) for Windows version 25.0. Skewness and kurtosis values were examined to determine whether the data showed a normal distribution. The data were evaluated using descriptive statistics (number, percentage, mean, standard deviation) and compared between the groups using chi-square and independent-samples t tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Virtual Reality
Virtual Reality glasses
experimental
intervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure.
Control
Patients in the control group underwent upper endoscopy following the standard protocol.
No interventions assigned to this group
Interventions
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experimental
intervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure.
Eligibility Criteria
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Inclusion Criteria
* Not using anticoagulants within the last 24 hours,
* Having no vision or hearing problems
* Not receiving sedation
* Having no cognitive or psychiatric disorder that may affect understanding and communication
Exclusion Criteria
ALL
Yes
Sponsors
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Çankırı Karatekin University
OTHER
Responsible Party
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Figen EROL URSAVAŞ
Associate professor
Principal Investigators
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Figen Erol Ursavaş
Role: PRINCIPAL_INVESTIGATOR
Cankırı Karatekin Univeristy
Locations
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Figen Erol Ursavaş
Aksu, Çankırı, Turkey (Türkiye)
Countries
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Other Identifiers
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CankırıKUE
Identifier Type: -
Identifier Source: org_study_id