Postoperative sleep quality in TKA patients Surgery
Conditions
Interventions
Randomization and allocation concealment were implemented strictly. A random number table was generated using IBM SPSS version 26.0 to assign participants in a 1:1 ratio to either the Sham Auricular A
Sponsors
Hefei First People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =50 years 2. Diagnosis of knee osteoarthritis according to the criteria established by the International Society of Rheumatology 3. Scheduled to undergo unilateral TKA 4. Educational level of at least completion of compulsory primary education
Exclusion criteria
Exclusion criteria: 1. Presence of psychiatric disorders such as delirium, dementia, or other cognitive impairments 2. Peripheral nervous system injury or other musculoskeletal injuries 3. History of myocardial infarction or other severe cardiovascular diseases within the past 12 months 4. History of Raynaud’s disease 5. Active vasculitis or severe peripheral vascular disease 6. History of periprosthetic joint infection around the knee 7. History of substance abuse or drug dependence 8. Acupuncture-related phobia or aversion 9. Any other conditions deemed unsuitable for participation in clinical research by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Subjective sleep quality assessed using the Insomnia Severity Index (ISI), with scores ranging from 0 to 28. Higher scores indicate poorer sleep quality and more severe insomnia symptoms. Assessment time points included 1 day before surgery, and postoperative days 0 (day of surgery), 1, 3, and 5. All assessments were conducted at 7:00 AM on the morning following each designated time point. 2. Salivary melatonin levels measured using enzyme-linked immunosorbent assay (ELISA). Saliva samples (0.5 ml) were collected at 9:00 PM on the evening of 1 day before surgery, the day of surgery, and postoperative days 1, 3, and 5. Immediately after collection, samples were centrifuged, and the supernatant was separated and stored at -80°C for subsequent analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain assessed using a standardized dynamic monitoring protocol, Visual Analog Scale (VAS) Score, at the following timepoints: 1 day prior to surgery, 6 hours postoperatively, and on postoperative days 1, 3, and 5. Pain intensity was evaluated under two physiological conditions: (1) at rest; and (2) during functional activity, using a standardized 5-meter walking test. 2. Serum C-reactive protein (CRP) levels measured using blood samples collected at 24 hours before surgery and at 24 and 72 hours postoperatively. All samples were sent to the institutional laboratory for analysis. CRP levels were determined using an immunoturbidimetric assay. 3. Additional administration of sedative drugs: When patients reported difficulty falling asleep at night, they were first instructed to perform auricular acupoint stimulation. If sleep initiation remained unsuccessful and the patient expressed a strong need for pharmacological assistance, the night-shift assessor administered 5 mg of estazolam to aid sleep. The number of patients in each group who required sedative medication was carefully recorded for subsequent data analysis. 4. Adverse events were monitored and recorded throughout the treatment period in both groups. These included occurrences of nausea, dizziness, ear pain, numbness, infection, and allergic reactions related to the intervention. In addition, postoperative knee-related complications were also monitored, including periprosthetic joint infection, deep vein thrombosis (DVT) in the lower limbs, and knee joint stiffness. | — |
Countries
China
Contacts
Public ContactRende Ning
Outcome results
None listed