NCT05992714: (VR/WN_ ART)

Effects of VR and White Noise During Arthroscopy (VR/WN_ ART)

Status unknown NA Last updated 15 August 2023

What this trial tests

NA trial testing Virtual Reality Glasses group in Arthroscopic Surgical Procedures in 93 participants. Status unknown.

Timeline

30 September 2023

Primary endpoint
30 October 2023

30 November 2023

Quick facts

Lead sponsor	Seher Tanrıverdi
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	93
Start date	30 September 2023
Primary completion	30 October 2023
Estimated completion	30 November 2023

Drugs / interventions tested

• Virtual Reality Glasses group
• white noise group

Conditions studied

• Arthroscopic Surgical Procedures — all drugs for Arthroscopic Surgical Procedures →

Sponsor

Seher Tanrıverdi

Who can join

18 and older, any sex, with Arthroscopic Surgical Procedures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Today, arthroscopy is widely used in the diagnosis and of treatment intra-articular diseases. Arthroscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure especially spinal anesthesia. Along with physical discomfort during the procedure, it triggers, fear and anxiety in the patient.

Purpose: To examine the effects of virtual rain forest and white noise on patient satisfaction, pain, comfort and vital signs in patients of arthroscopic knee surgery.

Method: The population of the study consisted of all patients who applied to the Dicle University Hospital Orthopedics and Traumatology unit and were scheduled for arthroscopy in the operating room. Based on the sample size of Basak and Sahin's study using similar VR applications, 31 patients were determined for each group total 93 patients with 5% significance level and 80% power(13). G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 31 rain forest video VR group, 31 white noise group and 31 control group. Data will be collected in the in the operating room on weekdays when the procedure is performed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of virtual rainforest and a white noise mobile application on satisfaction, tolerance, comfort, and vital signs during arthroscopy.
   Genç H, Tanriverdi S, Sait Akar M. · · 2024 · cited 1× · PMID 38507879 · DOI 10.1016/j.ctcp.2024.101848