UMIN-CTR Clinical Trial

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
Email	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
Email	km204107@stu.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine Graduate School
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049587