Clinical Trial Protocol for Auditory Stimulation to Reduce Postoperative Sleep Disturbance

Xiaoxuan Hu's protocol describes a randomized controlled trial investigating intraoperative 40 Hz gamma frequency auditory stimulation for postoperative sleep disturbance. The trial plans to enroll 342 patients undergoing laparoscopic gynecological surgery, with outcomes including sleep incidence, anxiety scores, pain, and recovery quality. The protocol was last updated on 2026-04-16 and is available under a CC-BY-4.0 license.

Use Cases

• Analyzing the effect of auditory stimulation on postoperative sleep incidence based on the primary outcome measure.
• Modeling relationships between stimulation and secondary outcomes like anxiety (HADS-A), depression (HADS-D), and pain scores.
• Studying protocol design for randomized, double-blind controlled trials in a surgical population.
• Investigating correlations between sleep disturbance and recovery metrics like Quality of Recovery (QoR-15) scores and hospital stay length.

Strengths

• Protocol is structured for a randomized, double-blind controlled trial with a planned enrollment of 342 patients.
• Defines a comprehensive set of primary and secondary outcomes including sleep incidence, psychological scores, pain, and recovery metrics.
• Documentation includes clinical trial registration details (ChiCTR2500110341) and is openly licensed (CC-BY-4.0).

Limitations

• The dataset is a 32.4 KB DOCX protocol document; the actual trial data is not included, limiting direct analysis.
• Column-level documentation for any resulting data is absent; field semantics must be inferred from the protocol.
• Row count for any future trial dataset is unknown, which may limit suitability assessment.

Provenance

Source

Xiaoxuan Hu via figshare.

Collection Method

Protocol document for a planned clinical trial.

Time Range

Protocol publication date is 2026-04 16; trial temporal coverage is not specified.

Freshness

Last updated 2026-04-16 05:16:37; freshness should be verified as it is a future date.

Geography

Spatial coverage is not specified, but the trial registry is Chinese (chictr.org.cn).