Effect of Virtual Reality on Anxiety, Stress, Pain and Patient`s Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial

Last registered on September 16, 2024
View Trial History

Pre-Trial

Trial Information

General Information

Title
Effect of Virtual Reality on Anxiety, Stress, Pain and Patient`s Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial
RCT ID
AEARCTR-0014334
Initial registration date
September 09, 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
September 16, 2024, 11:51 AM EDT

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

Locations

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

Primary Investigator

Name
khulud mansor
Affiliation
aaup
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
On going
Start date
2024-08-18
End date
2024-12-18
Keywords
Health
Additional Keywords
Effect of Virtual Reality on Anxiety, Stress, Pain and Patient`s Satisfaction among Patients Undergoing Colonoscopy
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Effect of Virtual Reality on Anxiety, Stress, Pain and Patient`s Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial.

The current study aims to study the effect of virtual reality on anxiety, stress, pain, and patient satisfaction during colonoscopy procedure. The results of this study may contribute to evaluating the effectiveness of virtual reality technology in reducing and treating the level of anxiety, stress and pain among patients instead of traditional methods and common pharmaceutical methods and raising the level of patient satisfaction during this procedure. Moreover, it adds to evidence-based practice by using VR as a method for treating mental health disorders, including stress and anxiety.

The researcher starts collecting data from patients before starting procedure, patients will complete socio-demographic data, STAI, and PSS-10, which take approximately 25–30 minutes. The patient will receive an immersive VR intervention that includes meditative 3D videos for the natural environment by head-mounted device, and earphones to listen to soothing nature sounds for 30 minutes. Post procedure, the researcher redistributed questionnaires among patients in both groups, which included STAI and PSS-10, and VAS to evaluate patients' satisfaction levels and pain level which take approximately 25–30 minutes.

External Link(s)

Registration Citation

Citation
mansor, khulud. 2024. "Effect of Virtual Reality on Anxiety, Stress, Pain and Patient`s Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial." AEA RCT Registry. September 16. https://doi.org/10.1257/rct.14334-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
1. The researcher starts collecting data from patients before starting procedure, patients will complete socio-demographic data, STAI, and PSS-10, which take approximately 25–30 minutes.
2. The patient will receive an immersive VR intervention that includes meditative 3D videos for the natural environment by head-mounted device, and earphones to listen to soothing nature sounds for 30 minutes.
3. Post procedure, the researcher redistributed questionnaires among patients in both groups, which included STAI and PSS-10, and VAS to evaluate patients' satisfaction levels and pain level which take approximately 25–30 minutes.
Intervention Start Date
2024-08-18
Intervention End Date
2024-12-18

Primary Outcomes

Primary Outcomes (end points)
To investigate the effect of virtual reality on anxiety, stress, pain, and patients’ satisfaction among Palestinian patients undergoing colonoscopy.
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 (Hariton & Locascio, 2018).
Experimental Design Details
Not available
Randomization Method
Randomized block design will be used to select and divide participants into different groups to avoid selection bias.
Randomization Unit
Randomized block design will be used to select and divide participants into different groups to avoid selection bias.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
The total 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 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 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
Arab American University -Ramalla
IRB Approval Date
2024-08-18
IRB Approval Number
R-2024/A/129/N
Analysis Plan