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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038234
Receipt No. 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 2020/10/07

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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
Email furuta.marie.8r@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Matsufuji
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
Homepage URL
Email matsufuji.hiromi.55a@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043383

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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