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

Sponsor
Seher Tanrıverdi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05992714
Collaborator
(none)
93
3
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Glasses group
  • Device: white noise group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel Assignment experimental model using randomized pretest and posttest with control groupParallel Assignment experimental model using randomized pretest and posttest with control group
Masking:
Double (Participant, Investigator)
Masking Description:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Virtual Rain Forest and White Noise on Satisfaction, Tolerance, Comfort and Vital Signs During Arthroscopy
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patient Information Form [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

  2. Visual Analogue Scale (VAS) [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.

  3. The Patient Observation Form [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seher Tanrıverdi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Seher Tanrıverdi, Asistant Professor, Mardin Artuklu University
ClinicalTrials.gov Identifier:
NCT05992714
Other Study ID Numbers:
  • vr/white noise
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seher Tanrıverdi, Asistant Professor, Mardin Artuklu University

Study Results

No Results Posted as of Aug 15, 2023