UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051697 |
|---|---|
| Receipt number | R000059002 |
| Scientific Title | Changes in salivary oxytocin levels after stimulation of C-tactile afferents in healthy Japanese women: a quasi-experimental pilot study |
| Date of disclosure of the study information | 2023/07/24 |
| Last modified on | 2023/07/25 19:41:18 |
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Basic information
Public title
Changes in salivary oxytocin levels after tactile stimulationin in healthy Japanese women
Acronym
Changes in salivary oxytocin levels after tactile stimulationin
Scientific Title
Changes in salivary oxytocin levels after stimulation of C-tactile afferents in healthy Japanese women: a quasi-experimental pilot study
Scientific Title:Acronym
Changes in salivary oxytocin levels after stimulation of C-tactile afferents
Region
| Japan |
Condition
Condition
Healthy Japanese women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in salivary oxytocin levels following tactile stimulation with warmth, specifically targeting the activation of C-tactile afferents in healthy women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin level
Key secondary outcomes
Salivary cortisol level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The saliva collection and questionnaire surveys conducte at two points: before (O1) and after (O2) the intervention. The participants are asked to hold a neonatal female doll (weight: 3 kg; KOKEN, Tokyo, Japan) with their forearms for 15 min. To stimulate C-tactile afferents and reproduce neonatal body temperature, the neonatal doll is warmed to around body temperature.
Interventions/Control_2
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
| 41 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy Japanese women
Key exclusion criteria
1) diagnosed with an infectious disease, including coronavirus disease 2019
2) current smoker
3) pregnant
4) breastfeeding
5) previous delivery
6) childcare experience
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Sonoda |
Organization
Takarazuka University
Division name
School of Nursing
Zip code
5300012
Address
1-13-16 Shibata, Kita-ku, Osaka
TEL
+81-6-6373-4829
nozomi-sonoda@takara-univ.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Sonoda |
Organization
Takarazuka University
Division name
School of Nursing
Zip code
5300012
Address
1-13-16 Shibata, Kita-ku, Osaka
TEL
+81-6-6373-4829
Homepage URL
nozomi-sonoda@takara-univ.ac.jp
Sponsor or person
Institute
Tatakarazuka 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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Takarazuka University
Address
1-13-16 Shibata, Kita-ku, Osaka
Tel
+81-6-6373-4829
nozomi-sonoda@takara-univ.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
| 2023 | Year | 07 | Month | 24 | 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
12
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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059002
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
