Clinical trial NCT05668143: Effect of Intraoperative Virtual Reality on Anxiety and Vital Findings in Patients Total Knee Replacement Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement Surgery
Virtual Reality
Keywords: Intraoperative
Virtual Reality
Anxiety
Vital Findings
Patients
Total Knee Replacement Surgery
Lead sponsor: Bucak State Hospital
Sponsor class: OTHER_GOV
First posted: 2022-12-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: State Anxiety Scale
timeFrame: 10 minute
measure: Respiratory Rate
timeFrame: 15 minute
measure: Blood Pressure (both systolic and diastolic blood pressure)
timeFrame: 15 minute
measure: Pulse
timeFrame: 15 minute
measure: Saturation Value
timeFrame: 15 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Bucak State Hospital
Study officials:
affiliation: Bucak State Hospital
name: Yusuf Beşirik, MScN student
role: PRINCIPAL_INVESTIGATOR
affiliation: KTO Karatay University
name: Serap Sayar, PhD
role: STUDY_DIRECTOR
References: