UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054639 |
|---|---|
| Receipt number | R000062438 |
| Scientific Title | Evaluation of Autonomic Nervous System Function During Sleep by Mindful Breathing Using a Tablet Device: Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2024/06/12 14:49:33 |
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Basic information
Public title
Research on the effects of mindfulness using tablet devices
Acronym
Evaluation of Autonomic Nervous System Function During Sleep by Mindful Breathing Using a Tablet Device
Scientific Title
Evaluation of Autonomic Nervous System Function During Sleep by Mindful Breathing Using a Tablet Device: Randomized Controlled Trial
Scientific Title:Acronym
Evaluation of Autonomic Nervous System Function During Sleep by Mindful Breathing Using a Tablet Device
Region
| Japan |
Condition
Condition
Sleep, stress
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of mindfulness breathing exercises using a tablet device, autonomic nervous system function during sleep was evaluated using cardiac potentials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The experiment will consist of two components: "verification" and "measurement".
Verification."
Duration: 9 days (weekdays)
Location: At home
Frequency: Once a day, before bedtime
Contents:
Mindfulness breathing group: Performing mindfulness breathing exercises
Control group: Gaze at crosses on tablet device screen
Measurement
Location: At home
Measurements: cardiac potentials during sleep
Subjects: Mindfulness breathing group and control group
Measurement days: Day 1, Day 5, and Day 9
Evaluation index: Low Frequency (LF), High Frequency (HF), and LF/HF ratio calculated from cardiac potential analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mindful Breathing
Interventions/Control_2
Gaze at the crosshairs on the tablet device
Interventions/Control_3
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1st to 4th year nursing students
Ages 18 to 22 years old
Key exclusion criteria
(1) Have previous meditation and mindfulness experience.
(2) Those with a history of sleep disorders
(3) Those who are taking sleep inducing drugs or other medications.
(4) Those whose sleep-wake rhythm is not consistent.
(5) Those who work part-time during the nighttime hours.
(6) Those who consume alcohol or excessive caffeine.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Togo |
Organization
Hyogo University
Division name
Department of Nursing, Faculty of Nursing
Zip code
675-0195
Address
2301, Hiraoka-cho Shinzaike, Kakogawa City, Hyogo, Japan
TEL
079-427-5111
tougo@hyogo-dai.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Togo |
Organization
Hyogo University
Division name
Department of Nursing, Faculty of Nursing
Zip code
675-0195
Address
2301, Hiraoka-cho Shinzaike, Kakogawa City, Hyogo, Japan
TEL
079-427-5111
Homepage URL
tougo@hyogo-dai.ac.jp
Sponsor or person
Institute
Hyogo University
Institute
Department
Personal name
Funding Source
Organization
Hyogo 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
Hyogo University
Address
2301, Hiraoka-cho Shinzaike, Kakogawa City, Hyogo, Japan
Tel
079-427-5111
tougo@hyogo-dai.ac.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
| 2024 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
The low frequency power (LF value) and LF/HF ratio of the mindfulness-applied group showed a significant correlation on day 1 compared to days 5 and 9.
Results date posted
| 2024 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062438
