Effect of Virtual Reality on Intraoperative Anxiety and Stress among Palestinian Patients undergoing Regional Anesthesia

Last registered on March 06, 2024
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Pre-Trial

Trial Information

General Information

Title
Effect of Virtual Reality on Intraoperative Anxiety and Stress among Palestinian Patients undergoing Regional Anesthesia
RCT ID
AEARCTR-0013093
Initial registration date
February 23, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 06, 2024, 3:15 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

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Primary Investigator

Name
khulud mansor
Affiliation
aaup
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Other Primary Investigator(s)

Additional Trial Information

Status
On going
Start date
2024-01-24
End date
2024-09-20
Keywords
Health
Additional Keywords
endoscopy, colonoscopy, breast biopsy, urinary surgery, orthopedic surgery, general surgery, cesarean suction
JEL code(s)
Secondary IDs
Prior work
This trial is based on or builds upon one or more prior RCTs.
Abstract
Anxiety is a normal response that emerges from surgical operations and anesthesia, can affect the perioperative anesthetic management and overall surgical outcomes such as increasing anesthetic requirement, delayed awaking, postoperative pain, delaying in wound healing, impair immune system response, increased risk of infection, hypertension, dysrhythmias, nausea, vomiting, prolonged recovery period and hospitalization. The aim of the study is to investigate the effect of virtual reality on intraoperative anxiety and stress among Palestinian patients undergoing regional anesthesia. An experimental design known as randomized control trials (RCT) will be used in this study. The study will be conducted at Rafidia Surgical Hospital, a government hospital in Nablus City, West Bank, Palestine. Patients who meet the inclusion criteria will be randomly assigned to two groups: immersive VR group and control-group. Tools for data collection will be used: The State-Trait Anxiety Inventory (STAI), Perceived Stress Scale (PSS-10), and Visual Analog Scale (VAS).
External Link(s)

Registration Citation

Citation
mansor, khulud. 2024. "Effect of Virtual Reality on Intraoperative Anxiety and Stress among Palestinian Patients undergoing Regional Anesthesia." AEA RCT Registry. March 06. https://doi.org/10.1257/rct.13093-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
patients assigned to the VR group will receive an immersive VR intervention that includes meditative 3D videos for the natural environment by a head-mounted device and earphones to listen to soothing nature sounds for 30 minutes. For natural environment that will be presented by VR glasses, universes were proposed: tropical beach, diving, forests, snowy landscape, with relaxing music with nature sound and the patient can choose one of them. It will be selected based on Guided Meditation VR application, developed by CUBICLE NINJAS AGENCY. https://guidedmeditationvr.com/. If, before 30 minutes, there was a patient who felt uncomfortable and wanted to stop using VR, it will be excluded from study and recorded in study report. The control group will receive traditional care during operation.
Intervention Start Date
2024-04-20
Intervention End Date
2024-09-20

Primary Outcomes

Primary Outcomes (end points)
investigate the effect of virtual reality on intraoperative anxiety and stress among Palestinian patients undergoing regional anesthesia.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
An experimental design known as randomized control trials (RCT) will be used in this study. Such a design fits the nature of the problem under investigation; an RCT will be used to investigate the effect of a new intervention without bias. This is because the act of randomization balances participant characteristics (both observed and unobserved) between the groups, allowing the attribution of any differences in outcome to the study intervention.
Experimental Design Details
Not available
Randomization Method
Randomized block design
Randomization Unit
Patients who meet the inclusion criteria will be randomly assigned to two groups: immersive VR group and control-group. Randomized block design will be used to select and divide participants into different groups to avoid selection bias. It ensures that participants are assigned to groups with an equal probability, and the same number of participants for each group. Also, will be prepared opaque, sealed envelopes numbered sequentially to conceal the allocation sequences (Chiu et al., 2023). For blinding, because of the nature of the intervention, the participants and researcher could not be blinded, only the anesthesiologist will be blind to the patients’ groups during the regional anesthesia procedure.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
The total sample was 128 participants. To overcome the attrition rate and who refused to participate, the final sample was 150 participants 75 participants per group (75 in VR group and 75 in control group).
Sample size: planned number of observations
The total sample was 128 participants. To overcome the attrition rate and who refused to participate, the final sample was 150 participants 75 participants per group (75 in VR group and 75 in control group).
Sample size (or number of clusters) by treatment arms
The total sample was 128 participants. To overcome the attrition rate and who refused to participate, the final sample was 150 participants 75 participants per group (75 in VR group and 75 in control group).
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan