臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 25, 2024
Last modified on	Oct. 25, 2024
Trial ID	jRCT2062240073

Scientific Title	Impact of digital health education on stress anxiety and depression of women with polycystic ovarian syndrome- a randomized controlled trial (Impact of digital health education on stress anxiety and depression of women with PCOS- RCT study)
Public Title	Polycystic ovarian syndrome and it's impact (PCOS Impact)

Contact for Scientific Queries	Name	Akter Sadia
	Affiliation	Hiroshima University
	Address	Sadia Akter, Hiroshima City
	Telephone	+81-7090324736
	E-mail	d234263@hiroshima-u.ac.jp
Contact for Public Queries	Name	Akter Sadia
	Affiliation	Hiroshima University
	Address	Sadia Akter, Hiroshima City
	Telephone	+81-7090324736
	E-mail	d234263@hiroshima-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 25, 2024
Actual date of first enrollment		Dec. 02, 2024
Target sample size		212
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Women who have PCOS. Women who have an android mobile phone. Women who can read and write in Bengali. Women who give consent to participate.
	Exclusion Criteria	Pregnant women. Women who have heart disease, kidney disease, respiratory disease and any other chronic debilitating disease.
	Age Minimum	17age old exceed
	Age Maximum	50age old not
	Gender	Female
Health Condition(s) or Problem(s) Studied		Stress anxiety Depression
Intervention(s)		Video (awareness video, physical activity video) and knowledge content related to PCOS
Health Condition(s) Keyword		PCOS, Polycystic Ovarian Syndrome, Stress Anxiety, Depression, Mental Health, Obesity, Cortisol, Testerone, BMI
Intervention(s) Keyword		Digital Health, Smartphone Application, mHealth, awareness, education
Health Condition(s) Code		D011085
Intervention(s) Code		D063731
Primary Outcome(s)		Improved anxiety, stress, or depression of women with PCOS
Secondary Outcome(s)		Improved cortisol level. (Cortisol level high one of the causes for depression) Improved prolactin and testosterone level that are associated with PCOS Improved knowledge on PCOS of the participants Improved BMI of the patients suffering from PCOS

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	Satake Fund
Secondary Sponsor

Source of Monetary Support	Satake Fund Research Grant
Secondary Sponsor	Applicable

Name of Certified Review Board	Approval of Research Protocol #2024/0R-NSU/IRBII 002
Address	ADM 625. Plot: 15, Block: B, Bashundhara, Dhaka-I 229, Bangladesh., Hiroshima
Telephone	+81-7090324736
E-Mail
Approval Status	Approval
Date of approval	Oct. 22, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	Bangladesh