Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06159829 |
| Other study ID # |
CankiriKUE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 22, 2022 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Çankiri Karatekin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Virtual reality (VR) is a tool that uses three-dimensional computer
graphics-based technologies to make an individual feel as if they are physically in the
virtual environment by misleading their senses. In recent years, the use of VR has been
widely used in clinical applications such as anxiety disorders, pain, and stress coping VR
can be used to relieve acute pain and anxiety in hospitalized patients and was shown in
several studies to reduce pain and anxiety levels Aim: to evaluate the effect of virtual
reality on anxiety and pain in patients who underwent upper endoscopy without sedation.
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.
Description:
Gastrointestinal (GI) diseases are an important public health problem in Turkey and
worldwide.The prevalence of upper GI diseases in Turkey is reported to be 32.7%. A
large-scale global study suggested that more than 40% of people have GI disease that affects
quality of life and use of health services.
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.
