UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038234 |
|---|---|
| Receipt number | R000043383 |
| Scientific Title | The effect of expressive writing on psychological and physical health among postpartum women in Japan: a randomised controlled trial |
| Date of disclosure of the study information | 2019/10/08 |
| Last modified on | 2022/04/12 15:01:19 |
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Basic information
Public title
The effect of expressive writing on psychological and physical health among postpartum women in Japan: a randomised controlled trial
Acronym
The effect of expressive writing on psychological and physical health among postpartum women in Japan: a randomised controlled trial
Scientific Title
The effect of expressive writing on psychological and physical health among postpartum women in Japan: a randomised controlled trial
Scientific Title:Acronym
The effect of expressive writing on psychological and physical health among postpartum women in Japan: a randomised controlled trial
Region
| Japan |
Condition
Condition
Post-traumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of expressive writing after childbirth on psychological and physical health among postpartum women in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms of birth-related PTSD at 1 month postpartum
Key secondary outcomes
Symptoms of birth-related PTSD at 3 months postpartum
Symptoms of depression at 1 month and 3 months postpartum
The number of contacts with health care professionals at 1 month and 3 months postpartum
Breastfeeding practice at 1 month and 3 months postpartum
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Expressive writing with usual postpartum care
Interventions/Control_2
Usual postpartum care
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Postpartum women within 72 hours after delivery
2) Women who can understand instructions and answer questionnaires in Japanese
Key exclusion criteria
1) Women with a psychiatric diagnosis or receiving treatment for mental disorders
2) Women who are clinically judged inappropriate to participate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Furuta |
Organization
Graduate School of Medicine, Kyoto University
Division name
Human Health Science
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3972
furuta.marie.8r@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Matsufuji |
Organization
Kyushu University
Division name
Department of Health Sciences, Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582
TEL
092-642-6749
Homepage URL
matsufuji.hiromi.216@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan society for promotion of Science (JSPS)
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
Ethics Committee, Graduate School and Faculty of Medicine, Kyoto University
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501
Tel
075-753-4680
ethcom@kuhp.kyoto-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
医療法人 金井産婦人科 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 08 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
