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Effect of perioperative binaural beats on postoperative mental state in breast cancer surgery patients

Effect of perioperative binaural beats on postoperative mental state in breast cancer surgery patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089005
Enrollment
Unknown
Registered
2024-08-30
Start date
2023-10-25
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

perioperative anxiety

Interventions

intervention group:After anesthesia induction, binaural noise-canceling headphones were used to play pure binaural beats, of which standard tone frequencies are at 400 Hz and differences between the t
control group:Play muted files using binaural noise-canceling headphones after anesthesia induction

Sponsors

The First Affiliated Hospital of Chongqing Medical University, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Female patients aged 18-60 years, ASA grade I-II, BMI < 18.5<28, who are scheduled to undergo modified radical mastectomy.

Exclusion criteria

Exclusion criteria: (1) Patients undergoing autologous tissue breast reconstruction; (2) Combined with neuropsychiatric disorders, cognitive dysfunction or inability to complete self-rating scales; (3) Long-term or latest one-week use of psychotropic or opioids; (4) Received general anesthesia within one week or is not suitable for the anesthesia protocol of this study for any reason; (5) Patients diagnosed with chronic anxiety, depression, sleep disorders, and pain; (6) Patients with preoperative anxiety; (7) Pre-existing hearing loss or impairment before surgery; (8) Insufficient literacy level such as reading and inability to complete good communication; (9) history of drug abuse or dependence; (10) Participated in other clinical trials within the past 1 year.

Design outcomes

Primary

MeasureTime frame
incidence of anxiety;

Secondary

MeasureTime frame
anxiety scores;depression scores;propofol dosage;pain rating;sleep rating;usage of PCIA;adverse effect;usage of rescue analgesia;

Countries

China

Contacts

Public ContactJie Luo

The First Affiliated Hospital of Chongqing Medical University

jieluo@hospital.cqmu.edu.cn+86 157 3007 6532

Outcome results

None listed

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