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

NCT05668143 | Completed

• 1 other identifier: 2022/008
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement Surgery; Virtual Reality

Keywords

Intraoperative; Virtual Reality; Anxiety; Vital Findings; Patients; Total Knee Replacement Surgery

Outcome Measures

Primary Outcomes (5)

• State Anxiety Scale

  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

  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)

  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

  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

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

During the surgery, patients will be shown nature and landscape images with virtual reality glasses.

Behavioral: Virtual reality

Control group

NO INTERVENTION

The control group will receive standard procedure without any intervention.

Interventions

Virtual reality BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bucak State Hospital: lead

Study Sites (1)

Bucak State Hospital

Burdur, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Yusuf Beşirik, MScN student

  Bucak State Hospital

  PRINCIPAL INVESTIGATOR

• Serap Sayar, PhD

  KTO Karatay University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 29, 2022
• Study Start: December 30, 2022
• Primary Completion: April 10, 2023
• Study Completion: January 31, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

TU (1)