UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049656 |
|---|---|
| Receipt number | R000056535 |
| 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 |
| Date of disclosure of the study information | 2023/12/30 |
| Last modified on | 2022/12/05 16:35:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Obstetrics 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
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
poltekkes-smg@poltekkes-smg.ac.id
Sponsor or person
Institute
Postgraduate Applied Masters of Midwifery, Poltekkes Kemenkes Semarang.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056535
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
