Study on the effectiveness of auricular acupressure in improving sleep after knee surgery
| ISRCTN | ISRCTN61333726 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61333726 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | HZR2444/Hwk2024zd001/No. AHWJ2024Aa30021 |
| Sponsor | Hefei First People's Hospital |
| Funders | Health Research Project of Health Commission of Anhui Province, Hefei Municipal Natural Science Foundation, Key Project of Health Commission Applied Medical Research of Hefei, Basic and Clinical Collaborative Research Promotion Initiative of the Third Affiliated Hospital of Anhui Medical University |
- Submission date
- 02/04/2025
- Registration date
- 03/04/2025
- Last edited
- 03/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study aims to assess the effectiveness and safety of auricular acupressure (AA) therapy in improving postoperative sleep quality in patients undergoing total knee arthroplasty (TKA), a surgical procedure to replace a damaged knee joint with artificial components. Postoperative sleep disorders are common after TKA and can hinder recovery. By exploring auricular acupressure, this study investigates a non-pharmacological intervention to alleviate sleep disturbances and improve recovery outcomes.
Who can participate?
Patients aged 50 years or older, diagnosed with knee osteoarthritis and scheduled for unilateral TKA
What does the study involve?
Participants will be randomly assigned to either the auricular acupressure (AA) group or the sham auricular acupressure (SAA) group. Both groups will receive similar treatments, but only the AA group will receive active auricular acupressure therapy, which involves the stimulation of specific points on the ear. The study involves assessments of sleep quality, pain levels, and biomarkers such as melatonin and CRP before and after surgery. The intervention will be administered on the day of surgery, with follow-up for 5 days after surgery.
What are the possible benefits and risks of participating?
Possible benefits include improved sleep quality, reduced pain, and enhanced recovery due to decreased inflammation. The risks are minimal and may include minor discomfort at the acupressure points, such as mild ear pain or skin irritation. No serious adverse events related to the intervention have been observed so far. Participants will be closely monitored for any side effects.
Where is the study run from?
Hefei First People's Hospital (China)
When is the study starting and how long is it expected to run for?
June 2024 to March 2025
Who is funding the study?
This work was supported by Grants from the Health Research Project of Health Commission of Anhui Province (No. AHWJ2024Aa30021), the Hefei Municipal Natural Science Foundation (HZR2444), the Key Project of Health Commission Applied Medical Research of Hefei (Hwk2024zd011), the Basic and Clinical Collaborative Research Promotion Initiative of the Third Affiliated Hospital of Anhui Medical University (2022sfy007).
Who is the main contact?
Rende Ning, nrd1972@outlook.com
Contact information
Public, Scientific, Principal investigator
No. 390 Huaihe Road
First People's Hospital of Hefei
Hefei
230000
China
 ORCID ID |
0000-0002-5355-263X |
|---|---|
| Phone | +86 (0)13956966305 |
| nrd1972@outlook.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness and safety of auricular acupressure therapy for postoperative sleep disorders following total knee arthroplasty: a randomized controlled trial comparing auricular acupressure to sham auricular acupressure |
| Study objectives | Auricular acupressure (AA) can significantly improve postoperative sleep quality and reduce the incidence of postoperative sleep disorders in patients undergoing total knee arthroplasty (TKA). |
| Ethics approval(s) |
Approved 25/11/2024, Ethics Committee of The First People's Hospital of Hefei (No. 390 Huaihe Road, First People's Hospital of Hefei, Hefei, 230000, China; +86 (0)551-82137855; hfyykjcyc@126.com), ref: 2024-278-02 |
| Health condition(s) or problem(s) studied | Postoperative sleep quality in TKA patients |
| Intervention | 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 Acupressure (SAA) group or the Auricular Acupressure (AA) group. The treatment assignments were sealed in sequentially numbered, opaque envelopes. An independent physician opened the envelope upon patient admission and informed the nursing staff to arrange the corresponding intervention, thereby achieving allocation concealment. Outcome assessors, data collectors, and statistical analysts were not involved in the intervention procedures and remained blinded to group assignments. Participants were also blinded throughout the study, creating a double-blind environment. Both groups received standardized anesthesia and postoperative intravenous analgesia protocols. Auricular acupressure interventions were administered at 7:00 AM on the day of surgery by the same licensed acupuncturist with a mid-level professional qualification. In the AA group, six specific auricular acupoints - Shenmen (TF4), Sympathetic (AH6), Endocrine (CO18), Heart (CO15), Liver (CO12), and Kidney (CO10) - were identified using a metal probe. After disinfection with alcohol, adhesive patches containing Vaccaria seeds were applied to the targeted points. In the SAA group, blank adhesive tape of a similar color was used to cover the same acupoints. Following the intervention, all patients were instructed to press each taped point 4–5 times per day, for 3–5 minutes per session, over a period of 7 consecutive days. All procedures were standardized, and the acupuncturist did not have further contact with the patients after completing the intervention in order to prevent potential bias from additional interaction. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 15/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 107 |
| Total final enrolment | 88 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 25/10/2024 |
| Date of final enrolment | 05/03/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Hefei
230000
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/04/2025: Study's existence confirmed by the Ethics Committee of The First People's Hospital of Hefei.
