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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049587


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name