UMIN-CTR Clinical Trial

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
Institute	Gunma University Graduate School of Health Science
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031734