It Was Planned as a Single-blind Randomized Controlled Study to Determine the Effect of Virtual Reality Goggles on Pain, Anxiety and Sleep in Patients Undergoing Total Knee Arthroplasty.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Postoperative pain intensity measured by the Numeric Rating Scale (NRS)
Study Overview
Brief Summary
Knee osteoarthritis, which occurs after degeneration of the knee joint with age, is common in women after 65 years of age and surgical methods are generally used in the treatment of deformity, pain and limitation of movement. This surgical procedure is different from other surgical procedures.
It takes a long time to perform activities of daily living and return to quality life. At the same time, pain, anxiety and sleep disorders are among the most common problems in the postoperative period. In addition to pharmacological methods, non-pharmacological methods (listening to music, watching movies, daydreaming, humor, virtual reality application, laughter) are used to reduce these problems. In recent years, especially virtual reality application has started to be used as a distraction-based approach in recent years. Virtual reality is the artificial creation of a three-dimensional environment through computer technology. In this application, it is ensured that the individual feels that he/she is a part of the created virtual environment with immersive environments that seem effective. This study was planned to determine the effect of virtual reality glasses on pain, anxiety and sleep in patients undergoing total knee arthroplasty. The study will be conducted with participants who are willing to participate in the study and whose consent has been obtained.
One group will receive virtual reality goggles (experiment) and the other group will receive standard care.
Control group
They will be asked to evaluate their level of "Anxiety and Pain" before and two days after Total Knee Arthroplasty surgery and their level of Sleep at their convenience after waking up the next day.
Experimental group
In addition to the standard care and practices applied to the participants in the control group, you will be asked to watch videos of relaxing nature scenes wearing "Virtual Reality Goggles". These videos last 30 minutes. You will be asked to fill in the same scales for two days preoperatively and two days postoperatively as the participants in the control group.
Detailed Description
For Patient Registries: Also describe the applicable registry procedures and other quality factors (for example, third party certification, on-site audit). In particular, summarize any procedures implemented as part of the patient registry, including, but not limited to the following:
Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems).
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used (for example, World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Since it is a single-blind randomized controlled trial, the nurse and the statistician evaluating the data will not be informed about the experimental and control groups.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing elective primary total knee arthroplasty due to knee osteoarthritis
- •Patients able to communicate in Turkish
- •Patients mobilized on the first postoperative day according to the hospital's standard postoperative care protocol
- •Patients with a postoperative pain score ≥4 on the Numerical Rating Scale
- •Patients providing written informed consent
Exclusion Criteria
- •Patients experiencing postoperative complications (e.g., severe bleeding, persistent nausea or vomiting),
- •Cognitive or sensory impairment,
- •Psychiatric disorders, communication difficulties, history of dizziness, uncontrolled hypertension, or patients using sedative or anxiolytic drugs were excluded from the study.
Arms & Interventions
Virtual Reality Group
Participants received standard postoperative care plus a nurse-guided virtual reality intervention.
Intervention: Virtual Reality Group (Device)
Control Group
Participants received standard postoperative care according to the orthopaedic clinic protocol.
Outcomes
Primary Outcomes
Postoperative pain intensity measured by the Numeric Rating Scale (NRS)
Time Frame: Immediately before and immediately after each VR session on postoperative day 1 and postoperative day 2
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), with higher scores indicating greater pain.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sennur Kula Şahin
Assist Prof
Istinye University