Binaural Beat Technology and Rhythmical Photic Stimulation
- Conditions
- Depression
- Interventions
- Other: Relaxing music groupOther: Sound and light therapy (BBT and FL group)Other: Sound therapy group (BBT)
- Registration Number
- NCT05666661
- Lead Sponsor
- National Cheng Kung University
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 75
- (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.
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Relaxing music group Relaxing music group 30 minutes of intervention every day for 14 consecutive days. Sound and light therapy group (BBT and FL group) Sound and light therapy (BBT and FL group) 30 minutes of intervention every day for 14 consecutive days. Sound therapy group (BBT) Sound therapy group (BBT) 30 minutes of intervention every day for 14 consecutive days.
- Primary Outcome Measures
Name Time Method Beck Depression Inventory-II (BDI) On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes. There were 21 questions in the BDI, and a self-rated method was used for participants to fill in their thoughts in the last 2 weeks. A 4-point Likert scale was used. The score range of each question was 0-3 points. A total score of 0-12 points was normal, 14-19 points was mild depression, 20-28 points was moderate depression, and 29-63 points was severe depression.
HRV analyzer On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 5 minutes. HRV was used to measure heart rate variability, including five markers: (1) Mean heart rate; (2) SDNN: Standard deviation of all RR intervals, represent the physiological health of autonomic nervous system; the higher the SDNN, the better the physiological health of the autonomic nervous system; (3) nLF: Normalized low frequency, reflects sympathetic nervous activity. The higher the value, the greater the activity; (4) nHF: Normalized high frequency, reflects parasympathetic nervous activity. The higher the value, the greater the activity; (5) LF/HF, a marker reflecting sympathetic and parasympathetic nervous activity.
Pittsburgh Sleep Quality Index (PSQI) On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes. There were 18 questions in the PSQI, and participants used a self-rated method to fill in their sleep quality in the last month on a 4-point Likert scale. The total score range was 0-21 points. The higher the score, the poorer the sleep quality. This scale has seven dimensions, including: (1) Subjective sleep quality; (2) Sleep latency; (3) Sleep duration; (4) Sleep efficiency; (5) Sleep disturbances; (6) Daytime dysfunction; and (7) Use of sleep medication. PSQI had good validity and reliability(Tsai et al., 2005).
- Secondary Outcome Measures
Name Time Method Vitality scales (VT) On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes. The vitality (VT) and mental health scales (MH) in SF-36 were used for measurement of secondary outcomes The SF-36 scale covers eight dimensions and 36 questions. Each dimension can be used for testing separately and has good validity and reliability (Yang et al., 2018). The VT and MH scales have four and five questions, respectively. A 6-point Likert scale is used. The score of each question ranges from 1 to 6 points and the total score of the VT and MH scales are 4-24 and 5-30 points, respectively. A higher score indicates better vitality or mental health.
Mental health scales (MH) On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes. The vitality (VT) and mental health scales (MH) in SF-36 were used for measurement of secondary outcomes The SF-36 scale covers eight dimensions and 36 questions. Each dimension can be used for testing separately and has good validity and reliability (Yang et al., 2018). The VT and MH scales have four and five questions, respectively. A 6-point Likert scale is used. The score of each question ranges from 1 to 6 points and the total score of the VT and MH scales are 4-24 and 5-30 points, respectively. A higher score indicates better vitality or mental health.
Trial Locations
- Locations (1)
Asia Univeraity
🇨🇳Taichung, WuFeng, Taiwan