UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043432 |
|---|---|
| Receipt number | R000049587 |
| Scientific Title | Effectiveness of using back massage to decrease psychological stress of mother who have child in NICU(neonatal insensitive care unit) |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/09/02 22:41:01 |
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Basic information
Public title
Effectiveness of using back massage to decrease psychological stress of mother who have child in NICU(neonatal insensitive care unit)
Acronym
Effectiveness of using back massage to decrease psychological stress of mother who have child in NICU(neonatal insensitive care unit)
Scientific Title
Effectiveness of using back massage to decrease psychological stress of mother who have child in NICU(neonatal insensitive care unit)
Scientific Title:Acronym
Effectiveness of using back massage to decrease psychological stress of mother who have child in NICU(neonatal insensitive care unit)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exam the care that decrease psychological stress of mothers who have children in NICU by using back massage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of STAI "state anxiety scale" decreases.
Key secondary outcomes
<study1>
Blood pressure,pulse rate,LF/HF decrease.
<study2>
Blood pressure,pulse rate decrease.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1.Putting on equipments(active tracer,blood flow meter),getting information(questionnaire,subjective indicator:STAI)
2.Maintaining a sitting position for 10 min
3.Getting information
Physiological measurements included blood pressure,pulse rate,body temperature
4.controls:Maintaining a sitting position for 15min
interventions:Giving a back massage for 15 min
5.Getting information
Physiological measurements included blood pressure,pulse rate,body temperature
6.Maintaining a sitting position for 15 min
7.Getting information
Physiological measurements included blood pressure,pulse rate,body temperature
8.Taking off equipments,getting information(questionnaire,subjective indicator:STAI)
Interventions/Control_2
1.Putting on equipments(blood flow meter),getting information(questionnaire,subjective indicator:STAI)
2.Maintaining a sitting position for 10 min
3.Getting information
Physiological measurements included blood pressure,pulse rate
4.Giving a back massage for 15min
5.Getting information
Physiological measurements included blood pressure,pulse rate
6.Maintaining a sitting position for 15 min
7.Getting information
Physiological measurements included blood pressure,pulse rate
8.Taking off equipments,getting information(questionnaire,subjective indicator:STAI)
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
<study1>
1.Those who are in good health
2.Those who can consent to this study with a document
3.Those who aged 20 to under 45 years old when they consent
4.Female,health care workers
5.Menstrual women can be eligible within 10 days (low temperature period) after the end of menstruation
6.Those who can receive the control group and the intervention group at least one week apart
7. Those who can participate after work
<study2>
1.Mothers who discharged and have children enter to NICU
2.Mothers who can consent to this study with a document
3.Mothers aged 20 to under 45 years old when they consent
Key exclusion criteria
<study1>
1.Those who with mental illness
2.Those who are pregnant or may be pregnant
3.Those who fall under the contraindications to massage
<study2>
1.Mothers with mental illness
2.Mothers who have children prognosis in not good
3.Those who the children's doctor judges inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Murota |
Organization
Kyoto Prefectural University of Medicine Graduate School
Division name
Graduate School of Nursing for Health Care Science
Zip code
602-0857
Address
410 Nakagoryo-cho,Kamigyo-ku, Kyoto City,Kyoto
TEL
075-212-5437
murota@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Horimoto |
Organization
University Hospital Kyoto Prefectural University of Medicine
Division name
nursing department
Zip code
602-8566
Address
465 Kajii-cho,Hirokoji,Kawaramachi-Dori,Kamigyo-ku, Kyoto City,Kyoto
TEL
075-251-5111
Homepage URL
km204107@stu.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine Graduate School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine ,Medical Ethics Review Board
Address
465 Kajii-cho,Hirokoji,Kawaramachi-Dori,Kamigyo-ku, Kyoto City,Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院（University Hospital Kyoto Prefectural University of Medicine）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
| 2021 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | 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
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049587
