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

Sponsor
Bucak State Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05668143
Collaborator
(none)
70
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2
3
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual reality
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The patients will be divided into two as the experimental and control group.The study will be conducted as a randomized controlled trial. Patients in the experimental group will be informed about the using virtual reality glasses during total knee replacement surgery.The patients will be divided into two as the experimental and control group.The study will be conducted as a randomized controlled trial. Patients in the experimental group will be informed about the using virtual reality glasses during total knee replacement surgery.
Masking:
Single (Participant)
Masking Description:
Single Blinded
Primary Purpose:
Health Services Research
Official Title:
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
Actual Study Start Date :
Dec 30, 2022
Anticipated Primary Completion Date :
Feb 6, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. State Anxiety Scale [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.

  2. Respiratory Rate [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.

  3. Blood Pressure (both systolic and diastolic blood pressure) [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.

  4. Pulse [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.

  5. Saturation Value [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bucak State Hospital Burdur Turkey

Sponsors and Collaborators

  • Bucak State Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yusuf Beşirik, Principal Investigator, Bucak State Hospital
ClinicalTrials.gov Identifier:
NCT05668143
Other Study ID Numbers:
  • 2022/008
First Posted:
Dec 29, 2022
Last Update Posted:
Jan 4, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yusuf Beşirik, Principal Investigator, Bucak State Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023