Arthropathy of Knee
Conditions
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. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and
Interventions
Participants received standard postoperative care plus a nurse-guided virtual reality intervention.
Sponsors
Study design
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.
Intervention model description
Patients who did not receive virtual reality goggles (control group) will receive standard care and treatment. They will be asked to fill out the "State Anxiety Inventory Scale" and "Pain Visual Comparison Scale" form on the first and second postoperative day, and the "Richards-Campbell Sleep Scale" form when appropriate after waking up the next day. Virtual reality goggles were applied (experimental group): In addition to the standard care and treatment practices applied to the patients in the control group, they will be asked to watch videos with relaxing nature views with virtual reality glasses. These videos will be shown for 20-25 minutes twice a day, 2-3 hours after surgery and on the second day, in the morning and evening hours (before sleep) without analgesic administration (at least one hour). Scales will be administered to determine pain, anxiety and sleep levels immediately before and after wearing the virtual glasses.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity measured by the Numeric Rating Scale (NRS) | 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. |
Countries
Turkey (Türkiye)