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Effects of Intraoperative 40Hz Gamma Wave Auditory Stimulation on Postoperative Sleep Disturbance in Patients Undergoing Laparoscopic Gynecological Surgery: A Prospective, Double-Blind, Randomized Controlled Trial

Effects of Intraoperative 40Hz Gamma Wave Auditory Stimulation on Postoperative Sleep Disturbance in Patients Undergoing Laparoscopic Gynecological Surgery: A Prospective, Double-Blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110341
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

postoperative sleep disturbance

Interventions

Group A:None
Group B:Wearing headphones without 40Hz gamma wave auditory stimulation
Group C:Wearing headphones with 40Hz gamma wave auditory stimulation for one hour (headphone model: Sennheiser MOMENTUM 4
manufacturer: Sonova Consumer Hearing GmbH
speaker frequency response range: 6Hz-22kHz)

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female patients aged over 18 years scheduled to undergo laparoscopic gynecological surgery under general anaesthesia; 2. An estimated operative time (from anesthesia induction to surgical incision closure) is more than 1 hour;

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation, or menstruation; 2. Long-term use of antidepressants, psychotropic medications, or recent history of substance abuse; 3. Comorbidities including severe respiratory insufficiency, bronchial asthma, severe hypertension, abnormal liver or kidney function (ChildPugh class C or renal replacement therapy), or severe cardiovascular diseases; 4. History of epileptic seizures; 5. Pre-existing central nervous system disorders, psychiatric conditions, or language communication barriers; 6. Inability to wear headphones due to conditions such as auricular deformity; 7. Participants who have taken part in other clinical trials within the past 4 weeks; 8. Patients with contraindications or a history of allergies to the drugs used in the study protocol;

Design outcomes

Primary

MeasureTime frame
Incidence of Postoperative Sleep Disturbance;

Secondary

MeasureTime frame
incidence of postoperative sleep disturbance (PSD) ;AIS scores postoperatively ;HADS-A scores postoperatively;HADS-D scores postoperatively;use of sedative-hypnotic medications;pain scores at rest and while coughing;analgesic usage;incidence of postoperative nausea and vomiting (PONV);rescue antiemetics usage;length of PACU stay;length of postoperative hospital stay;quality of postoperative recovery;incidence of perioperative adverse events;patient satisfaction;

Countries

China

Contacts

Public ContactLiu Huayue

The First Affiliated Hospital of Soochow University

docliu.hy@163.com+86 153 6538 8833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 18, 2026