UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027703
Receipt number R000031734
Scientific Title An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women
Date of disclosure of the study information 2017/08/01
Last modified on 2022/06/13 09:05:47

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Basic information

Public title

An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women

Acronym

An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women

Scientific Title

An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women

Scientific Title:Acronym

An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women

Region

Japan


Condition

Condition

healthy Women

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The present study aimed to assess the efficacy of passive muscle relaxation (PMR) in healthy women

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

salivary amylase
Profile of Mood States

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Passive muscle Relaxation

Interventions/Control_2

Rest

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

40 years-old >

Gender

Female

Key inclusion criteria

1.Women 20 years or older
2.Health does not have disorder
3.We are not taking medicine
4.It is not during menstruation,
5.We do not conduct relaxation in everyday life

Key exclusion criteria

Health is defective
We are taking medicine
It is during menstruation
We conduct relaxation in everyday life
Women younger than 20 years

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yuka
Middle name
Last name Kondo

Organization

Gunma University

Division name

Graduate School of Health Science

Zip code

371-8511

Address

3-29-22 Showa-Machi, Maebashi Gunma,371-8511

TEL

027-220-7111

Email

yukondo@gunma-u.ac.jp


Public contact

Name of contact person

1st name Yuka
Middle name
Last name Kondo

Organization

Gunma University

Division name

Graduate School of Health Science

Zip code

3718511

Address

3-29-22 Showa-Machi, Maebashi Gunma,371-8511

TEL

027-220-7111

Homepage URL


Email

yukondo@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University
Graduate School of Health Science

Institute

Department

Personal name



Funding Source

Organization

Gunma University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma University

Address

Mabashi City, Showamachi2-39-22

Tel

0272208982

Email

yukondo@gunma-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



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 08 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

40

Results

A total of 40 subjects, whose average age was 22.1(SD,3.5)years. sAA values:With regard to changes over time following stress tests and immediately after interventions, a significant decline (p=0.008)was observed in the passive muscle relaxation experiment, while no significant decline was observed(p=0.502)in the control experiment.

Results date posted

2020 Year 12 Month 11 Day

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

2017 Year 08 Month 01 Day

Date of IRB

2017 Year 05 Month 19 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2022 Year 06 Month 20 Day

Date of closure to data entry

2022 Year 06 Month 20 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 09 Day

Last modified on

2022 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031734


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name