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Study protocol outlines randomized trial of 40 Hz auditory stimulation for postoperative sleep disturbanceCould quiet headphones help patients sleep better after gynecological surgery?

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Key Takeaway
Note that this is a protocol; no outcome data are available to guide clinical use of 40 Hz auditory stimulation.

This publication details the protocol for a randomized controlled trial designed to assess the efficacy of intraoperative 40 Hz gamma frequency auditory stimulation. The planned population consists of 342 patients scheduled for laparoscopic gynecological surgery under general anesthesia. The study design includes a control group receiving no headphones and a sham stimulation group wearing headphones without auditory output.

The primary outcome is defined as the incidence of postoperative sleep disturbance on the first postoperative night. Secondary outcomes include incidence of postoperative sleep disturbance on postoperative nights 2 and 3, daily Athens Insomnia Scale scores, anxiety and depression scores, sedative-hypnotic use, pain scores, analgesic consumption, and incidence of postoperative nausea and vomiting. Additional measures include rescue antiemetic use, duration of post-anesthesia care unit stay, length of postoperative hospital stay, quality of postoperative recovery, perioperative adverse events, and patient satisfaction.

Specific results regarding the primary or secondary outcomes are not reported in this document. Safety data regarding perioperative adverse events are listed as a secondary outcome, but specific data are not reported. Serious adverse events, discontinuations, and tolerability details are also not reported.

As this is a protocol publication, follow-up duration is not reported. Practice relevance is not reported. Consequently, no conclusions regarding efficacy or safety can be drawn at this time. Clinicians should await the completion of the trial and subsequent publication of results before considering this intervention.

Many people face a tough night after surgery, unable to rest while their body heals. This study plan looks at a new idea: playing a 40 Hz sound frequency through headphones during the operation to help patients sleep better afterward. The team plans to compare this sound against having no headphones or headphones that play nothing at all. They will watch 342 patients scheduled for laparoscopic gynecological surgery under general anesthesia.

The researchers intend to measure how often patients have sleep trouble on the first night and check scores for anxiety, pain, and nausea. They also plan to see if patients need less pain medicine or spend less time in recovery. However, this document is just a protocol, which means it describes what they will do, not what they found.

Because no results are reported yet, we cannot say if this sound helps or if it causes any harm. The plan lists checking for side effects as a goal, but specific safety data is not available. Until the study is finished and results are published, this remains a question rather than an answer for patients.

What this means for you:
This is a study plan, not a result, so we do not yet know if sound helps sleep after surgery.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BackgroundPostoperative sleep disturbance (PSD) is a common complication after surgery and is associated with impaired recovery. This protocol describes a randomized controlled trial designed to determine whether intraoperative 40 Hz gamma frequency auditory stimulation reduces the incidence of PSD after laparoscopic gynecological surgery.MethodsThis randomized, double-blind, controlled trial will enroll 342 patients scheduled for laparoscopic gynecological surgery under general anesthesia. Patients will be randomly allocated in a 1:1:1 ratio to three parallel groups: control (no headphones), sham stimulation (headphones without auditory output), or active stimulation (headphones delivering 40 Hz auditory stimulation). The primary outcome is the incidence of PSD on the first postoperative night. Secondary outcomes include the incidence of PSD on postoperative nights 2 and 3, daily Athens Insomnia Scale (AIS) scores, anxiety and depression scores (HADS-A/-D), sedative-hypnotic use, pain scores, analgesic consumption, the incidence of postoperative nausea and vomiting (PONV), rescue antiemetic use, duration of post-anesthesia care unit (PACU) stay, length of postoperative hospital stay, quality of postoperative recovery (QoR-15), perioperative adverse events, and patient satisfaction.DiscussionThis trial will evaluate whether intraoperative 40 Hz gamma frequency auditory stimulation reduces PSD in patients undergoing laparoscopic gynecological surgery. The findings may provide evidence for a non-invasive perioperative strategy to mitigate sleep disruption and improve postoperative recovery.Clinical trial registrationhttp://www.chictr.org.cn, identifier [ChiCTR2500110341].
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