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| ID | Type | Description | Link |
|---|---|---|---|
| 834/UN4.6.4.5.31/PP26/2025 | Other Identifier | The Hasanuddin University Research Ethics Commission |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Theta BWE combined with natural sound |
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| Control group | Sham Comparator | BWE audio at a sham frequency |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theta brainwave entrainment combined with natural sound | Other | The Theta BWE-based binaural-beat auditory stimulation intervention will be implemented according to the following protocol. Participants in the intervention group will receive BWE audio through stereo headphones at two frequencies: binaural beats at 6 Hz (theta) and natural sounds. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success. |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score | The PSQI score will be used to assess participants' overall sleep quality. PSQI is a self-rated questionnaire comprising 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A PSQI score of more than five indicates poor sleep quality. | Baseline (enrollment) and at 2 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Theta power | Theta power is operationally defined as spectral power within the 4-8 Hz frequency range, quantified as absolute and relative theta power derived from FFT analysis of uantitative Electroencephalography (qEEG) recordings. Researchers will perform a qEEG examination using the international 10-20 system and install 19-32 electrodes on the scalp using electrodes in a lying position, record for 15 minutes with the eyes closed or open, and perform qEEG extraction to obtain the Fast Fourier Transform (FFT) theta absolute and relative power values. The measurements will be conducted before and after the intervention period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdul Muis, dr., Sp.S(K) | Department of Neurology, Faculty of Medicine, Universitas Hasanuddin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Hasanuddin Hospital | Makassar | South Sulawesi | 90245 | Indonesia |
The data that support the findings of this study will be available upon reasonable request.
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| BWE audio at a sham frequency | Other | The control group participants will listen to the BWE audio through stereo headphones at a sham frequency. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success. |
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| Baseline (enrollment) and at 2 weeks post-intervention |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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