Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery

NANot yet recruitingINTERVENTIONAL
Enrollment

1,281

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Delirium - PostoperativeSleep ProblemsCABGValve Surgery
Interventions
BEHAVIORAL

Cognitive behavioral therapy intervention

The cognitive behavioral intervention provides sleep-related education 7-14 days before surgery. The educational content should include the following aspects: 1) Establish a consistent bedtime and wake-up time, recommending a sleep schedule from 22:00 to 07:00, and avoid prolonged daytime naps; 2) Optimize the sleep environment by ensuring a quiet setting, turning off lights, and refraining from using mobile phones, computers, and other electronic devices 30 minutes before bedtime; 3) Manage diet by avoiding caffeinated foods such as chocolate, tea, and cola; 4) Engage in appropriate daytime activities as permitted by the patient's condition.

DIETARY_SUPPLEMENT

Melatonin intervention

Patients in the melatonin intervention group are required to take an oral melatonin of 5 mg at 30-60 minutes before sleep (administered at 21:00) nightly for 7 to 14 days before surgery. The melatonin was provided by Kangenbei Pharmaceutical Co., LTD. (Hangzhou, Zhejiang, China).

OTHER

Placebo intervention

Patients in the placebo group need to take oral placebos of 5 mg at 30-60 minutes (administered at 21:00) before sleep, nightly, for 7 to 14 days before surgery. The placebo is provided by Guangzhou Boji Biomedical Science Park Co., LTD. (Guangzhou, Guangdong, China).

All Listed Sponsors
lead

Yan Fuxia

OTHER

NCT06777342 - Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery | Biotech Hunter | Biotech Hunter