Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159829
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-11-15
Brief Title:
The Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy
Sponsor:
Çankırı Karatekin University
Organization:
Çankırı Karatekin University
Study Overview
Official Title:
Determination of the Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n50 or control group n50 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
Design A single-centre parallel-group randomised control trial Methods The study sample consisted of 100 patients assigned to the intervention group n50 or control group n50 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:
Gastrointestinal GI diseases are an important public health problem in Turkey and worldwideThe prevalence of upper GI diseases in Turkey is reported to be 327 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 55-483 of individuals undergoing upper GI tract endoscopy experience severe anxiety 156-516 experience moderate anxiety and 789 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 patients 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 patients 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 n50 or control group n50 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 youtubecom 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 250 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
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 55-483 of individuals undergoing upper GI tract endoscopy experience severe anxiety 156-516 experience moderate anxiety and 789 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 patients 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 patients 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 n50 or control group n50 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 youtubecom 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 250 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None