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Improvement of sleep quality in breast cancer patients with concurrent sleep disorders by cheek acupuncture: A double-blind, parallel arm randomized controlled trial

Study on the treatment of insomnia with cheek acupuncture

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085397
Enrollment
Unknown
Registered
2024-06-06
Start date
2024-06-15
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disturbances

Interventions

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients scheduled to undergo radical mastectomy or modified radical mastectomy under general anesthesia during daytime 2.Age ranging from 18 to 70 years 3.Body mass index (BMI) within the range of 18.5 to 25 kg/m2 4.American Society of Anaesthesiologists (ASA) physical status class I or II, 5. Patients suffered from sleep disturbance within 1 month before operation, Pittsburgh Sleep Quality index (PSQI)=7 6.Patients who learn about the trial in detail and sign the informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1.Patients and their families patient refusal to participate in the study 2.Patients with sleep apnea syndrome or other types of sleep disorders(such as restless legs syndrome) 3.Pregnant or lactating women 4.Patients combined with central nervous system diseases or psychiatric disorders or communication disorders 5.Patients with infected or ruptured skin at the acupuncture point or with abnormal coagulation function 6. Patients taking hypnotic drugs after admission to hospital and before surgery 7.The responsible surgeon determines that the patient is unsuitable for participation in the trial based on clinical assessment and judgment.

Design outcomes

Primary

MeasureTime frame
Total score of Pittsburgh Sleep Quality index;

Secondary

MeasureTime frame
PSQI-A Sleep quality;PSQI-B Sleep onset time;PSQI-C Sleep time;PSQI-D Sleep Efficiency;PSQI-E Sleep disorder;PSQI-F Hypnotic medications;PSQI-G Daytime dysfunction;Total sleep duration;Proportion of light sleep;Proportion of deep sleep;Proportion of REM sleep;Number of awakenings ;Continuity of deep sleep;Average score of rest postoperative pain ;Average score of activity postoperative pain ;Postoperative nausea and vomiting;

Countries

China

Contacts

Public ContactBao Naren

The First Affiliated Hospital of China Medical University

bnrlzh@sina.com+86 138 4202 1591

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026