Clinical trial NCT06906120: The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery
Official title: The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Artroscopic Surgery
Orthopedic Surgery
Keywords: virtual reality illustration
Orthopedic surgery
Virtual reality
Surgical anxiety
Surgical fear
Preoperative education
Patient satisfaction
Pain management
Physiological parameters
Surgical preparation
VR intervention
Pain assessment
Electrodermal activity
Patient education tools
Preoperative anxiety reduction
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Acibadem Altunizade Hospital, Istanbul
name: Acibadem Atasehir Hospital
First posted: 2025-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effects of an operating room tour conducted using virtual reality (VR) goggles on anxiety, surgical fear, post-operative pain, satisfaction levels, and physiological parameters in patients undergoing orthopedic surgery.

The intervention will involve a 360 degree educational video introducing the operating room environment, surgical team roles, and expected patient experience during the perioperative period. This video will be presented using Meta Quest 3 VR goggles. Participants in the intervention group will watch this video before surgery, while the control group will receive standard preoperative education.

The primary outcomes include changes in preoperative anxiety (STAI-I), surgical fear (Surgical Fear Scale), and physiological parameters (e.g., heart rate, blood pressure, and electrodermal activity). Secondary outcomes include post-operative pain and patient satisfaction. Data will be collected at multiple time points, including before and after the intervention, on the day of surgery, and during the postoperative period.

The study is designed as a randomized controlled trial with a sample size of 60 participants, equally distributed between intervention and control groups. Data analysis will include appropriate statistical tests based on variable distribution and group comparisons.

Detailed description: This study is a randomized controlled trial to be conducted on patients undergoing arthroscopic surgery. The intervention group will be shown a 9,5 minute virtual reality (VR) content, created by the researcher, through VR goggles. The video content will be recorded by the researcher and a team using an Insta360 Pro device. The content will be a simulation involving healthcare professionals in various roles. The footage will be taken from the patient's perspective.

Once the operating room introduction video is completed, expert opinions will be gathered from 10 professionals in the field. Among the experts, 2 will be academicians, 2 will be experienced operating room nurses with at least 10 years of experience, 2 will be orthopedic surgeons, 1 will be a patient who has undergone arthroscopic surgery, 1 will be an anesthesiologist, and 1 will be an anesthesia technician. If the validity index from expert feedback is at least 80%, the video will be finalized.

Before the training content is shown, the VR goggles will be sanitized using an appropriate antiseptic solution, and then placed on the patient. The training content will consist of a 3D operating room introduction video. The device to be used for this training is a portable VR headset developed by Meta. It offers an advanced VR experience with its Snapdragon XR2 Gen 2 processor and high-resolution screens. Additionally, the device complies with the European Union's CE marking requirements and the Federal Communications Commission (FCC) regulations in the United States.

The introduction video will feature a patient's perspective and will detail the entire process up until the administration of anesthesia. During the video, the nurse will provide simultaneous narration, which will be heard by the patient through headphones. The content of the video will cover processes such as the patient's exit from the hospital room, transfer to the operating room, surgical safety procedures, introduction of devices used in surgery, prevention of pressure ulcers and hypothermia, and monitoring stages. The nurse will remain with the patient throughout the training.

After the training content is shown, measurements will be taken using the scales at specified time intervals. The study will compare the differences in surgical fear, anxiety levels, physiological parameters, pain levels, and satisfaction between the control group and the intervention group.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-65 years
* Patients scheduled for arthroscopic surgery
* Those who have not undergone any previous surgical procedures
* Patients who will undergo surgery under general anesthesia
* Individuals without communication barriers
* Patients with clear consciousness, and orientation to person, place, and time
* Those with no neurological or psychiatric disorders
* Individuals with no severe visual or auditory impairments

Exclusion Criteria:

* Inability to communicate with the patients
* Development of a life-threatening health problem after surgery
* Transition to open surgery during the procedure
* Patients who wish to withdraw from the study

Primary outcomes:
measure: Preoperative anxiety level: State-Trait Anxiety Inventory - STAI
timeFrame: STAI trait:1 day before surgery, prior to intervention/education STAI state:1.Immediately after STAI-II measurement 2.Immediately after the intervention/education 3.On the day of surgery, prior to premedication 4.Within 2 hours after surgery
Secondary outcomes:
measure: Surgical fear level: Measured using the Surgical Fear Scale
timeFrame: 1. Immediately after STAI-I measurement, 2. Immediately after the intervention/education, 3.On the day of surgery, prior to premedication
Other outcomes:
measure: Pain level: Measured using the Numeric Rating Scale (NRS)
timeFrame: Pain levels will be recorded within the first 2 hours after surgery using the NRS.
measure: Physiological parameters: Measured using electrodermal activity (EDA), heart rate, blood pressure (systolic and diastolic), respiratory rate, and peripheral oxygen saturation (SpO2).
timeFrame: Before the intervention, immediately after the intervention, 20 minutes before the transfer to the operating room on the morning of surgery, and 15 minutes after arriving at the inpatient ward.
measure: Satisfaction
timeFrame: Satisfaction will be measured within 2 hours after discharge procedures have started.
Locations:
city: İstanbul
country: Turkey
facility: Acibadem Atasehir Hospitla
state: Ataşehir
city: İstanbul
country: Turkey
facility: Acibadem Altunizade Hospital
state: Ataşehir
Study officials:
References:
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