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

August 8, 2023 updated by: Seher Tanrıverdi

The Effect of Virtual Rain Forest and White Noise on Satisfaction, Tolerance, Comfort and Vital Signs During Arthroscopy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

18 aged and over, Written and verbal consent to participate in the study, Being conscious (person, place and time orientation), Undergoing colonoscopy for the first time Spinal anesthesia applied, Meniscus surgery will be performed patients.

Exclusion Criteria:

Having vision, hearing and communication problems, Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.), Diagnosed with visual, auditory and / or balance disorders, General anesthesia applied patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Glasses
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: 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
Experimental: White Noise
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 listened using phone
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
No Intervention: control group
Patients of the control group, will not receive any intervention except for applied routine hospital arthroscopy surgery procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Information Form
Time Frame: the fundamental characteristics of the patients will be filled in 10 minutes before the arthroscopy procedure
This form, which was created by the researcher; patients' age, gender, education level, marital status, employment status, income level, ASA level, chronic disease status, and previous surgery. It consists of a total of 9 questions
the fundamental characteristics of the patients will be filled in 10 minutes before the arthroscopy procedure
Visual Analogue Scale (VAS)
Time Frame: Change from Baseline Visual Analogue Scale in 1 hour

This scale developed by Price (1983) will be used in the research to determine the level of tolerance, comfort and satisfaction. It is a scale in which the distance between the two ends with a minimum value of 0 on one end and a maximum value of 10 on the other end is measured with a 10 cm ruler. In this context; The patient is explained that there are two endpoints and that he is free to mark any place between them that fits the severity of his pain.

The distance between the beginning of "no comfort, tolerance and satisfaction" and this point marked by the patient is measured and recorded in centimeters. It has been shown that the VAS is a valid tool for the measurement of psychological and health variables such as pain and satisfaction, which is widely used in clinical studies.
Change from Baseline Visual Analogue Scale in 1 hour
The Patient Observation Form
Time Frame: Change from Baseline The Patient Observation Form in 1 hour
This form, which was created by the researcher, the vital signs (pulse, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation values (SpO2) of the patients before and after the procedure were recorded the form.
Change from Baseline The Patient Observation Form in 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seher Tanrıverdi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • vr/white noise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided all IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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