UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039865 |
|---|---|
| Receipt number | R000045344 |
| Scientific Title | The effectiveness of passive music therapy for sleep disorder of college students |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2022/03/16 14:53:16 |
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Basic information
Public title
The effectiveness of passive music therapy for sleep disorder of college students
Acronym
The effectiveness of passive music therapy for sleep disorder of college students
Scientific Title
The effectiveness of passive music therapy for sleep disorder of college students
Scientific Title:Acronym
The effectiveness of passive music therapy for sleep disorder of college students
Region
| Japan |
Condition
Condition
Sleep disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research was to reveal the effect of listening to music on sleep problems in university students and to reveal the influence of music type on this effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
Key secondary outcomes
Sleep diary
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The subjects who are assigned to the designated music listening group listen to music for 40 minutes at bedtime at home every day for 4 weeks. They are given the same pieces of music by the experimenter and listen to the pieces every day. PSQI (Pittsburgh Sleep Quality Index) is administered twice before and after the 4-week experimental period.
Interventions/Control_2
The subjects who are assigned to the favorite music listening group listen to music for 40 minutes at bedtime at home every day for 4 weeks. Each subject prepares his or her favorite pieces of music and listens to the same pieces every day. PSQI is administered twice before and after the 4-week experimental period.
Interventions/Control_3
The subjects who are assigned to the non-listening group spend 4 weeks as usual but don't listen to music at bedtime and after bedtime. PSQI is administered twice before and after the 4- week experimental period.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) aged 18 to 30 and
2) usually sleep between 9 pm and 9 am the following day.
Key exclusion criteria
1) receiving treatment at a medical facility for a psychiatric disorder (including disorders involving alcohol, caffeine, or other substances) that is not a sleep disorder,
2) a physical disorder with pain or other physically uncomfortable symptoms, and
3) pregnancy.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokai University
Division name
Department of Psychiatry, School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa, 259-1193 JAPAN.
TEL
0463-93-1121
key@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Yamasato |
Organization
Tokai University
Division name
Graduate School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa, 259-1193 JAPAN.
TEL
0463-93-1121
Homepage URL
ami.yamasato@gmail.com
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board forClinical Research, Tokai University
Address
143 Shimokasuya, Isehara City, Kanagawa, 259-1193 JAPAN.
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
http://mj-med-u-tokai.com/pdf/450409.pdf
Publication of results
Published
Result
URL related to results and publications
http://mj-med-u-tokai.com/pdf/450409.pdf
Number of participants that the trial has enrolled
239
Results
Global PSQI scores after intervention were significantly smaller in the prescribed music group and preferred music group but there was no significant reduction in the no-music group. Comparing change in global PSQI scores after intervention between the three groups, we saw no significant difference between the prescribed music group and preferred music group.
Results date posted
| 2020 | Year | 03 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 20 | Day |
Baseline Characteristics
The subjects were 95 university students (43 males, 52 females; aged between 18 and 30).
Participant flow
Consent was obtained from 239 students, of whom 39 dropped out while completing the PSQI questionnaire and before the music intervention, leaving 200 students who completed the PSQI. Of these, we decided that 120 students were 'poor' sleepers (PSQI > 5) and 80 were 'good' sleepers (PSQI < 6). The 80 students with a PSQI score < 6 were withdrawn from the study at that point. After excluding the 80 students with PSQI score < 6, 1 student who did not meet the inclusion criteria (aged 31 or older), and 24 dropouts who did not complete the post-intervention PSQI questionnaire, 95 subjects in total were included for analysis. Of these 95 subjects, the prescribed music group contained 32 subjects, the preferred music group 33 subjects, and the no-music group 30 subjects.
Adverse events
None
Outcome measures
There was a significant decrease in PSQI total score after intervention in the designated music listening group (N=32) and favorite music listening group (N=33), and there wasn't a significant difference in the non-music listening group (N=30). In the comparison of the amount of change among the three groups, significant differences were observed between the non-music and the designated music listening group, and between the non-music and the preferred music ones. There was no significant difference between the designated music listening group and the preferred music listening group. In the comparison of PSQI component scores before and after intervention in each group, there was a significant difference in C1, C2, C7 in the designated music listening group, C1, C3, C5, C7 in the preferred music listening group, and C2 in the non-music listening group .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045344
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