UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058706 |
|---|---|
| Receipt number | R000067118 |
| Scientific Title | Evaluation of the Effects of Taktipro on Oxytocin Secretion, Stress Reduction, and Safety: An Extended Crossover Trial |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/08/05 19:35:52 |
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Basic information
Public title
A Study to Examine the Effects and Safety of Massage
Acronym
TOPS Trial
Scientific Title
Evaluation of the Effects of Taktipro on Oxytocin Secretion, Stress Reduction, and Safety: An Extended Crossover Trial
Scientific Title:Acronym
TOPS Trial (Taktipro's effect on Oxytocin secretion, Psychological stress, and Safety)
Region
| Japan |
Condition
Condition
Normal adults
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of Taktipro - a massage technique involving skin stimulation developed by Siv Ardeby in Sweden - by comparing it to receptive music therapy, a form of complementary and alternative therapy that does not involve tactile stimulation. Specifically, the study examines its effects on oxytocin secretion, stress reduction, and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary concentrations of oxytocin
Key secondary outcomes
Salivary cortisol concentration
Assessment of autonomic nervous function by heart rate variability (HRV) analysis
Japanese version of the State-Trait Anxiety Inventory (STAI)
Vital signs
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Tactile massage
Interventions/Control_2
Receptive music therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy Volunteer
Key exclusion criteria
Individuals with heart disease
Individuals taking medications that affect the autonomic nervous system
Individuals with a history of epilepsy or psychiatric disorders
Individuals who are pregnant
Target sample size
80
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
770-8509
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
0886339005
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
770-8509
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
Yukie IWASA
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
The Ethics Committee Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima
Tel
0886338512
brinshoshienk@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
徳島県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 30 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 08 | Month | 05 | 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=R000067118
