CompletedNot Applicable

Theta Brainwave Entrainment Combined With Natural Sound on Healthcare Shift Workers With Poor Sleep Quality: A Randomized Controlled Trial

Indonesia34 participantsStarted 2025-10-23

Plain-language summary

Brief summary The goal of this clinical trial is to investigate the effects of theta BWE combined with natural sounds on sleep quality in healthcare shift workers. The main questions it aims to answer are: * Does theta brainwave entrainment (BWE) in combination with natural sound improve the sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) score? * Does theta BWE in combination with natural sound change theta power based on quantitative electroencephalography (qEEG)? Researchers will compare theta BWE combined with natural sound to a BWE audio at a sham frequency to see if theta BWE improves sleep quality. Participants will: * undergo baseline assessments, including the PSQI questionnaire and a quantitative Electroencephalography (qEEG), before intervention is given. * receive theta BWE binaural beats (intervention group) or BWE audio at a sham frequency (control group) for 20-30 minutes daily for 14 days. * be re-measured on the PSQI questionnaire and qEEG assessment after the intervention period.

Who can participate

Age range

20 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * healthcare shift workers at Universitas Hasanuddin Hospital, Makassar, Indonesia. * healthcare shift workers for at least the past three months, * aged 20-50 years, * having poor sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) (\>5), * willing to participate in the entire study and sign an informed consent Exclusion Criteria: * having hearing impairment, * currently taking psychotropic medications that affect sleep patterns, * having a history of epilepsy, head trauma, or other brain disorders

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pittsburgh Sleep Quality Index (PSQI) score

Timeframe: Baseline (enrollment) and at 2 weeks post-intervention

Trial details

NCT IDNCT07440264

SponsorHasanuddin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-23

View on ClinicalTrials.gov More Poor Sleep Quality trials