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

Hasanuddin University

Status: Completed

Conditions: Poor Sleep Quality

Treatments: Other: Theta brainwave entrainment combined with natural sound; Other: BWE audio at a sham frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT07440264

834/UN4.6.4.5.31/PP26/2025 (Other Identifier)

UH25100814

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Intervention group

Experimental group

Description:

Theta BWE combined with natural sound

Treatment:

Other: Theta brainwave entrainment combined with natural sound

Control group

Sham Comparator group

Description:

BWE audio at a sham frequency

Treatment:

Other: BWE audio at a sham frequency