DepressionNCT05666661
Binaural Beat Technology and Rhythmical Photic Stimulation
A study testing Sound and light therapy (BBT and FL group), Sound therapy group (BBT) and Relaxing music group in people with Depression, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- Sound and light therapy (BBT and FL group), Sound therapy group (BBT) and Relaxing music group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Binaural Beat Technology Combined With Rhythmical Photic Stimulation in Treating Depressive Symptoms in Nurses
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.
- Conditions
- Depression
- Being tested
- Sound and light therapy (BBT and FL group), Sound therapy group (BBT), Relaxing music group
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound and light therapy (BBT and FL group)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)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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sound and light therapy group (BBT and FL group) | Experimental | 30 minutes of intervention every day for 14 consecutive days. Receives: Other: Sound and light therapy (BBT and FL group) |
| Sound therapy group (BBT) | Experimental | 30 minutes of intervention every day for 14 consecutive days. Receives: Other: Sound therapy group (BBT) |
| Relaxing music group | Sham comparator | 30 minutes of intervention every day for 14 consecutive days. Receives: Other: Relaxing music group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II (BDI)
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.
Measured: 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.
Pittsburgh Sleep Quality Index (PSQI)
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).
Measured: 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.
HRV analyzer
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.
Measured: 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.
Secondary outcomes (2)
Vitality scales (VT)
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.
Measured: 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.
Mental health scales (MH)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Sep 2021
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Shang-Yu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666661
- Sponsor's protocol ID
- CMUH110-REC3-021
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Binaural Beat Technology Combined With Rhythmical Photic Stimulation in Treating Depressive Symptoms in Nurses
- ClinicalTrials.gov ID
- NCT05666661
- Acronym / sponsor ID
- CMUH110-REC3-021
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sound and light therapy group (BBT and FL group) | Experimental | Other: Sound and light therapy (BBT and FL group)30 minutes of intervention every day for 14 consecutive days. |
| Sound therapy group (BBT) | Experimental | Other: Sound therapy group (BBT)30 minutes of intervention every day for 14 consecutive days. |
| Relaxing music group | Sham comparator | Other: Relaxing music group30 minutes of intervention every day for 14 consecutive days. |
Who may qualify
- Ages
- 25 to 55 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Sound and light therapy group (BBT and FL group) |
| 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. | Other | Sound therapy group (BBT) |
| Relaxing music groupParticipants 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. | Other | Relaxing music group |
Primary outcome
Beck Depression Inventory-II (BDI)
Time frame: 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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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).
HRV analyzer
Time frame: 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.
2 secondary outcomes
Vitality scales (VT)
Time frame: 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.
Mental health scales (MH)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound and light therapy (BBT and FL group), Sound therapy group (BBT) and Relaxing music group in people with Depression, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory-II (BDI) (time frame: 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.