Effects of auricular gua sha combined with auricular acupressure on sleep quality in young and middle-aged patients with insomnia
| ISRCTN | ISRCTN67031646 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67031646 |
| Sponsor | School of Nursing, Medical College of Soochow University |
| Funder | Investigator initiated and funded |
- Submission date
- 26/03/2026
- Registration date
- 27/03/2026
- Last edited
- 31/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Insomnia is a common sleep problem that can make daily life difficult. Some people also experience anxiety and low mood alongside poor sleep. This study looked at whether using ear acupressure together with a technique called Gua Sha on the ear could help people sleep better. The aim was to compare this combined treatment with ear acupressure on its own.
Who can participate?
Adults aged 18 years and older with insomnia were able to take part. Participants needed to have an insomnia severity score of at least 8. People were not able to take part if they had certain health problems, were pregnant or breastfeeding, had skin problems on their ears, or were allergic to the tape used in treatment.
What does the study involve?
Participants were randomly placed into one of two groups.
One group received ear acupressure once a week for 4 weeks. Small cowherb seeds were placed on specific points on the ear, and participants pressed each point several times a day.
The second group received the same ear acupressure plus ear Gua Sha once a week for 4 weeks. Gua Sha involved gentle scraping and massage of the ear using a copper tool.
All participants were asked to return for follow-ups up to one month after the treatment period.
What are the possible benefits and risks of participating?
Participants in the combined treatment group showed improvements in sleep and reductions in anxiety and low mood compared with the group that received acupressure alone. No serious side effects were reported during the study. Some people may have mild discomfort on the ear from the treatment.
Where is the study run from?
A specialty nurse-led clinic of a tertiary hospital of traditional Chinese medicine in Suzhou, Jiangsu Province, China
When is the study starting and how long is it expected to run for?
The first participant joined the study in March 2023. The study finished in June 2024.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Li Tian, tianlisz@suda.edu.cn
Contact information
Public, Scientific
No. 1 Shizi Street, Suzhou City, Jiangsu Province
Suzhou
215006
China
| Phone | +86 138 6259 6317 |
|---|---|
| tianlisz@suda.edu.cn |
Principal investigator
No. 18 Yangsu Road, Suzhou City, Jiangsu Province
Suzhou
215009
China
| Phone | +86 159 6225 2633 |
|---|---|
| tuzi_zheng@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Effects of auricular gua sha combined with auricular acupressure on sleep quality in young and middle-aged patients with insomnia |
| Study objectives | This study aimed to compare the clinical effect of auricular acupressure combined with auricular gua sha compared with auricular acupressure for insomnia patients. |
| Ethics approval(s) |
Approved 07/03/2023, Ethics Committee of Soochow University (No. 1 Shizi Street, Suzhou City, Jiangsu Province, Suzhou, 215009, China; +86 5120473567; ethics@suda.edu.cn), ref: SUDA20230307H05 |
| Health condition(s) or problem(s) studied | Insomnia |
| Intervention | Group A (control group): Auricular acupressure once weekly for 4 weeks. Cowherb seeds affixed to auricular acupoints (Shenmen, Endocrine, Heart, Subcortical, with pattern‑based additions). Participants press each point 5 times daily, 30 seconds per point. One ear per session, alternated weekly. Group B (intervention group): Auricular acupressure combined with auricular gua sha once weekly for 4 weeks. Auricular acupressure protocol identical to the control group. Auricular gua sha performed using a copper scraping tool, including ear microcirculation massage, ear meridian massage, and scraping along auricular regions. One ear per session, alternated weekly. The randomisation process was performed using a random number table to generate the allocation sequence. Sequentially numbered, opaque, sealed envelopes were used to conceal the allocation until intervention assignment. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. Sleep quality measured using Pittsburgh Sleep Quality Index (PSQI) at three time points: baseline (T0), after the fourth intervention (T4), and 1 month post‑intervention (T5) |
| Completion date | 04/06/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. In accordance with the diagnostic criteria of insomnia in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults (2017 edition) 2. ISI score >=8 points 3. Age >=18 years old, regardless of gender |
| Key exclusion criteria | 1. Those suffering from major organic diseases or mental and psychological diseases 2. Those who have recently planned to have a baby or are breastfeeding or pregnant 3. Ear skin with inflammation, eczema, ulcers, frostbite or larger scar organizers 4. People who are allergic to the tape or have other serious adverse events and are unable to complete the trial |
| Date of first enrolment | 17/03/2023 |
| Date of final enrolment | 04/06/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Informed consent form in Chinese | 26/03/2026 | No | No | |
| Protocol file | in Chinese | 26/03/2026 | No | No |
Additional files
- 49274 informed-consent-form.pdf
- Informed consent form in Chinese
- 49274 Protocol.pdf
- in Chinese
Editorial Notes
26/03/2026: Trial's existence confirmed by Ethics Committee of Soochow University.
