UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Combination of Progressive Muscle Relaxation (PMR) and Positive Affirmation on Mental Health, Heart Rate and Cortisol Levels in Pregnant Women
Acronym	The Effect of Combination of Progressive Muscle Relaxation (PMR) and Positive Affirmation on Mental Health, Heart Rate and Cortisol Levels in Pregnant Women
Scientific Title	The Effect of Combination of Progressive Muscle Relaxation (PMR) and Positive Affirmation on Mental Health, Heart Rate and Cortisol Levels in Pregnant Women
Scientific Title:Acronym	The Effect of Combination of Progressive Muscle Relaxation (PMR) and Positive Affirmation on Mental Health, Heart Rate and Cortisol Levels in Pregnant Women
Region	Asia(except Japan)

Condition
Condition	Medicine
Classification by specialty	Medicine in general Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Knowing the effect of a combination of progressive muscle relaxation (PMR) and positive affirmations on mental health, heart rate and levels pregnant woman cortisol.
Basic objectives2	Others
Basic objectives -Others	Analyzing the effect of a combination of progressive muscle relaxation (PMR) and positive affirmations on the mental health, heart rate and levels pregnant women cortisol in the intervention group and the control group
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mental health
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	n-of-1
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Given a combination of Progressive Muscle Relaxation (PMR) and Positive Affirmations for 6 sessions (3 times a week) for 20 minutes
Interventions/Control_2	Counseling was given as much as 6 sessions (3 times a week) for 10 minutes
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	Pregnant women with mental health disorders,Third trimester pregnant women gestational age 28-34 weeks, Pregnant women do not have congenital diseases, Ready mom
Key exclusion criteria	Normal pregnant women, Pregnant women with gestational age under 28 weeks and above 34 weeks, Pregnant women with mental health disorders who do not ready, Mothers taking anti-depressants
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Dian Middle name Purwohadi Last name Pusporini
Organization	Poltekkes Kemenkes Semarang
Division name	Master of Midwifery
Zip code	35361
Address	Jl. Sersan Keniray, Trimulyo, Tanjung Bintang, Lampung Selatan
TEL	085664246889
Email	dianpurpus@gmail.com

Public contact
Name of contact person	1st name Poltekkes Middle name Kemenkes Last name Semarang
Organization	Poltekkes Kemenkes Semarang
Division name	Master of Midwifery
Zip code	50268
Address	Jl. Tirto Agung Pedalangan Tembalang Banyumanik Semarang Jawa Tengah
TEL	0247460274
Homepage URL
Email	poltekkes-smg@poltekkes-smg.ac.id

Sponsor
Institute	Postgraduate Applied Masters of Midwifery, Poltekkes Kemenkes Semarang.
Institute
Department

Funding Source
Organization	Postgraduate Applied Masters of Midwifery, Poltekkes Kemenkes Semarang.
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	Postgraduate Applied Masters of Midwifery, Poltekkes Kemenkes Semarang.
Address	Jl. Tirto Agung Pedalangan Tembalang Banyumanik Semarang Jawa Tengah
Tel	0247460274
Email	poltekkes-smg@poltekkes-smg.ac.id

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	2023 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2022 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date	2023 Year 01 Month 10 Day
Last follow-up date	2023 Year 02 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 12 Month 01 Day
Last modified on	2022 Year 12 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056535