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Effect of binaural beat music on intraoperative EEG and postoperative sleep quality in patients undergoing breast cancer surgery: a randomised controlled trial

Effect of binaural beat music on intraoperative EEG and postoperative sleep quality in patients undergoing breast cancer surgery: a randomised controlled trial - Effect of binaural beat music on intraoperative EEG and postoperative sleep quality in patients undergoing breast cancer surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096106
Enrollment
Unknown
Registered
2025-01-17
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Postoperative sleep disorders

Interventions

Group B (experimental group):The patients wore headphones, and binaural beat music was played in the experimental group.
Group C (control group):The patients wore headphones and no music was played in the control group.

Sponsors

Liaoning Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. No contraindications to anaesthesia, no serious pre-operative underlying diseases, no cardiac, hepatic or renal dysfunction, etc. 2. Female patients 3. Elective surgery patients who are going to undergo breast cancer surgery, including total mastectomy, partial mastectomy, breast-conserving surgery, breast reconstruction surgery, and breast lymph node dissection. 4. Age 18-55 years old, ASA grade I-II 5. Patients with normal hearing, without bilateral deafness or severe hearing impairment. 6. No history of mental illness (e.g., depression, anxiety, schizophrenia, etc.) or neurological disease (e.g., epilepsy, Parkinson's disease, etc.), and not currently receiving any medication that may affect the function of the central nervous system. 7. No history of long-term use of psychoactive drugs (e.g., antidepressants, antipsychotics, benzodiazepines, etc.) or narcotic drug addiction. 8. No history of chronic sleep disorders, such as insomnia, sleep apnea syndrome, etc., and have not received any form of sleep therapy in the last month. 9. No serious cardiovascular, respiratory, hepatic or renal dysfunction, such as heart failure, severe chronic obstructive pulmonary disease, end-stage renal disease, etc. 10. No recent (past 6 months) history of major surgery or trauma. 11. Patients with early or intermediate stage breast cancer without distant metastasis. 12. Patients voluntarily sign an informed consent form, indicating that they understand the content of the study, the possible risks and benefits, and that they are willing to participate in the entire study process.

Exclusion criteria

Exclusion criteria: 1. Any patient with contraindications to surgery or anaesthesia. 2. Patients with anaemia (haemoglobin level below normal range), hypocalcaemia, hypomagnesaemia. 3. Patients with abnormal blood glucose, including patients with poorly controlled diabetes or a history of hypoglycaemia (blood glucose <= 3.9 mmol/L). 4. Patients with hyperthyroidism (hyperthyroidism). 5. Patients who are unwilling or unable to co-operate with the requirements of the study before or after surgery. 6. Patients who have received radiotherapy or chemotherapy that may affect the effectiveness of anaesthesia or study interventions.

Design outcomes

Primary

MeasureTime frame
Postoperative sleep quality;

Secondary

MeasureTime frame
Power spectral density of different EEG waveforms;Explosion inhibition ratio;Intraoperative dosage of vasoactive drugs;

Countries

China

Contacts

Public ContactHuang Zeqing

Liaoning Cancer Hospital & Institute

huangzeqing1973@163.com+86 189 0091 7545

Outcome results

None listed

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