Binaural Beat Technology and Rhythmical Photic Stimulation

NCT ID: NCT05666661

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-10-30

Brief Summary

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Background Many nurses must shoulder heavy workloads and often develop depressive emotions due to work stress. Previous studies pointed out that binaural beat technology (BBT) and rhythmical photic stimulation can effectively improve negative emotions but there are very few related empirical studies.

Objectives This study examined the effectiveness of BBT combined with rhythmical photic stimulation in improving depressive symptoms in nurses.

Methods This is a randomized controlled trial and nurses in central Taiwan were recruited as participants. These participants were randomized into three groups: BBT combined with rhythmical photic stimulation group, BBT group, and relaxing music group. The intervention period was 2 weeks, with 30 minutes per session. The Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), vitality and mental health scale (VT\&MH from SF-36), and heart rate variability (HRV) were used as parameters for pre- and posttest evaluation in this study. The Wilcoxon signed-rank test was used to test if there are significant differences in various parameters in the three groups before and after intervention. The Krusal-Wallis test was used to test for significant differences in parameter changes between the three groups.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Sound and light therapy group (BBT and FL group)

30 minutes of intervention every day for 14 consecutive days.

Group Type EXPERIMENTAL

Sound and light therapy (BBT and FL group)

Intervention Type OTHER

During intervention, the participants close their eyes and wear an eye mask and stereo earphones. They then listen to 30 minutes of 10 Hz BBT music (intercalated with relaxing music) through their mobile phone. The intervention music was first embedded in the participant's mobile phone and the BBT music application was purchased from the mobile phone app (Brainwave Studio software, Dalcoms Inc). When listening to music, 10 Hz light stimulation was added to the BBT and FL group (using a mobile phone). Table 1 shows the intervention status. The rhythmical photic stimulation program was a commercially available mobile phone app (Strobe Therapy software released by FuwhatSoft).

Sound therapy group (BBT)

30 minutes of intervention every day for 14 consecutive days.

Group Type EXPERIMENTAL

Sound therapy group (BBT)

Intervention Type OTHER

Participants in the sound therapy group (BBT) listened to 30 minutes of 10 Hz BBT music (intercalated with relaxing music) through their mobile phones. Except for rhythmical photic stimulation, the other steps were the same as the BBT and FL group.

Relaxing music group

30 minutes of intervention every day for 14 consecutive days.

Group Type SHAM_COMPARATOR

Relaxing music group

Intervention Type OTHER

Participants listened to 30 minutes of relaxing music (the same as that of the experimental groups) through their mobile phone. Except for rhythmical photic stimulation and 10 Hz BBT, the other steps were the same as the experimental groups.

Interventions

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Sound and light therapy (BBT and FL group)

During intervention, the participants close their eyes and wear an eye mask and stereo earphones. They then listen to 30 minutes of 10 Hz BBT music (intercalated with relaxing music) through their mobile phone. The intervention music was first embedded in the participant's mobile phone and the BBT music application was purchased from the mobile phone app (Brainwave Studio software, Dalcoms Inc). When listening to music, 10 Hz light stimulation was added to the BBT and FL group (using a mobile phone). Table 1 shows the intervention status. The rhythmical photic stimulation program was a commercially available mobile phone app (Strobe Therapy software released by FuwhatSoft).

Intervention Type OTHER

Sound therapy group (BBT)

Participants in the sound therapy group (BBT) listened to 30 minutes of 10 Hz BBT music (intercalated with relaxing music) through their mobile phones. Except for rhythmical photic stimulation, the other steps were the same as the BBT and FL group.

Intervention Type OTHER

Relaxing music group

Participants listened to 30 minutes of relaxing music (the same as that of the experimental groups) through their mobile phone. Except for rhythmical photic stimulation and 10 Hz BBT, the other steps were the same as the experimental groups.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* (1) BDI score ≥ 14 points; (2) aged between 20 and 50 years, and (3) did not undergo antidepressant treatment within 3 months before intervention and during intervention.

Exclusion Criteria

* (1) Subjects with a medical history of mixed psychosis, including schizophrenia, bipolar disorder, and dementia; (2) patients with current acute disease and unstable physiological status; (3) medical history of epilepsy; (4) patients with eye diseases; (5) vertigo (including Meniere's syndrome); (6) hearing loss; and (7) participated in electroconvulsive therapy or transcranial electrical stimulation within 1 month prior to or during intervention.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Yang Shang-Yu

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asia Univeraity

Taichung, WuFeng, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH110-REC3-021

Identifier Type: -

Identifier Source: org_study_id