UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048866 |
|---|---|
| Receipt number | R000055686 |
| Scientific Title | Effects of Tactil massage on oxytocin secretion and stress reduction and its safety: a crossover study |
| Date of disclosure of the study information | 2022/09/06 |
| Last modified on | 2025/08/05 19:54:59 |
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Basic information
Public title
Effects of massage on oxytocin secretion and stress reduction
Acronym
Effects of massage on oxytocin secretion and stress reduction
Scientific Title
Effects of Tactil massage on oxytocin secretion and stress reduction and its safety: a crossover study
Scientific Title:Acronym
Effects of Tactil massage on oxytocin secretion and stress reduction and its safety: a crossover study
Region
| Japan |
Condition
Condition
Normal adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the oxytocin-secreting, stress-relieving, and safety effects of Tactil massage compared to passive music therapy, a type of complementary and alternative therapy that does not stimulate the skin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Salivary concentrations of oxytocin
Key secondary outcomes
Concentration of Ccortisol in saliva
Cortisol
Alpha-amylase
BDNF
Evaluation of autonomic nervous system function by heart rate variability analysis
State-Trait Anxiety Inventory: STAI
POMS2
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Tactil massage (10 min)
Interventions/Control_2
Receptive music therapy (10 min)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy Volunteer
Key exclusion criteria
Persons with skin disease
Persons with cardiac disease
Persons taking medications that affect the autonomic nervous system
Persons with epilepsy or pre-existing psychiatric disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yukie |
| Middle name | |
| Last name | Iwasa |
Organization
Tokushima University
Division name
Graduate School of Biomedical Sciences
Zip code
7708509
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9005
iwasa.yukie@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Iwasa |
Organization
Tokushima University
Division name
Graduate School of Biomedical Sciences
Zip code
7708509
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
0886339005
Homepage URL
iwasa.yukie@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University
Address
3-18-15 Kuramoto-cho, Tokushima
Tel
0886339005
iwsa.yukie@tokushima-u.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
徳島大学（徳島県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 06 | 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
40
Results
Results date posted
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055686
