UMIN-CTR Clinical Trial

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	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
Email	matsufuji.hiromi.216@m.kyushu-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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043383