Effect of Intraoperative Virtual Reality on Anxiety and Vital Findings in Patients Total Knee Replacement Surgery

February 1, 2024 updated by: Yusuf Beşirik, Bucak State Hospital

The Effect of Intraoperative Virtual Reality Application on the Level of Anxiety and Vital Findings in Patients Who Will Have Total Knee Replacement Surgery: A Randomized Controlled Study

Although total knee replacement surgery improves the quality of life of the patients, a significant reduction in knee pain and normalization of the knee joint, the awareness of the surrounding events is a major concern for the patients and negatively affects their vital signs, since most of the patients are awake during the surgery. When the literature is examined, there are no pharmacological methods to reduce anxiety.

When distraction techniques are used, patients' anxiety levels are significantly reduced, vital signs are normalized, patient satisfaction is increased and pain is relieved.

It has been emphasized that there is a successful method in reducing One of the distraction techniques is the application of virtual reality. This study will be carried out in a randomized controlled experimental design to determine the effect of virtual reality application during surgery on patients who will undergo total knee replacement surgery, on the anxiety level and vital signs of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine the effect of virtual reality application on patients' anxiety level and vital signs during surgery for patients who will undergo total knee replacement surgery.

It will consist of patients over the age of 18 who will have total knee replacement surgery, which will be carried out in the Operating Room Unit. Patients meeting the sample selection criteria were randomized into experimental and control groups.

will be divided into two groups. Virtual reality glasses will be applied to the experimental group. In the collection of data; "Patient Information Form", "State Anxiety Inventory Scale" and "Vital Signs Follow-up Form" will be used.

Study Type

Interventional

Enrollment (Actual)

70

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 Locations

  • Turkey
      • Burdur, Turkey
        • Bucak State Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntarily agreed to participate in the research
  • Being 18 years or older
  • Being able to read and write Turkish
  • No vision and hearing problems
  • Not using glasses
  • Absence of any psychiatric, cognitive or neurological disease

Exclusion Criteria:

  • Patients with visual or hearing impairment
  • Patients receiving general anesthesia
  • Those who have previously had total knee replacement surgery

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
During the surgery, patients will be shown nature and landscape images with virtual reality glasses.
Behavioral: Virtual reality
The Patient Information Form and the State Anxiety Scale will be administered to the patients just before the surgery. The researcher will measure the patient's respiratory, blood pressure, pulse and oxygen saturation values on the monitor just before the start of the operation and every 15 minutes after the operation, and the vital signs will be recorded in the follow-up form. Virtual reality glasses will be put on the patient immediately after anesthesia is given to the patient by the anesthesiologist. Glasses will be worn during the total knee replacement surgery. Total knee replacement surgery takes an average of 60 minutes. During the surgery, patients will be shown nature and landscape images with virtual reality glasses. Virtual reality glasses will be removed immediately after the operation and the State Anxiety Scale and vital signs follow-up form will be applied before the patient is sent to the service from the operating room.
No Intervention: Control group
The control group will receive standard procedure without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety Scale
Time Frame: 10 minute
State Anxiety Scale mean scores of the patients in the intervention and control groups will be compared before and after surgery. A minimum of 20 and a maximum of 80 points can be obtained from the scale. If the scale score approaches 80, it indicates high anxiety.
10 minute
Respiratory Rate
Time Frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's respiratory rate values will be measured on the monitor and the respiratory rate will be recorded in the follow-up form.
15 minute
Blood Pressure (both systolic and diastolic blood pressure)
Time Frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's blood pressure (both systolic and diastolic blood pressure) values will be measured on the monitor and the blood pressure (both systolic and diastolic blood pressure) will be recorded in the follow-up form.
15 minute
Pulse
Time Frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's pulse values will be measured on the monitor and the pulse will be recorded in the follow-up form.
15 minute
Saturation Value
Time Frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's saturation value will be measured on the monitor and the saturation will be recorded in the follow-up form.
15 minute

Collaborators and Investigators

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

Sponsor

Bucak State Hospital

Investigators

  • Principal Investigator: Yusuf Beşirik, MScN student, Bucak State Hospital
  • Study Director: Serap SAYAR, PhD, KTO Karatay University

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 (Actual)

December 30, 2022

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/008

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.

Subscribe