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

NCT05992714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-08-15

No results posted yet for this study

Summary

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.

Conditions

  • Arthroscopic Surgical Procedures

Interventions

DEVICE

Virtual Reality Glasses group

Except for the preparation of the patient for the procedure, since the arthroscopy procedure takes approximately 60 minutes, 60-minute 360-degree VR video scenes will be watched using VR head device

DEVICE

white noise group

Except for the preparation of the patient for the procedure, since the arthroscopy procedure takes approximately 60 minutes, 60-minute 360-degree VR video scenes will be watched using phone

Sponsors & Collaborators

  • Seher Tanrıverdi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2023-10-30
Completion
2023-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05992714 on ClinicalTrials.gov