UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development and Evaluation of Smartphone Website Supporting Antenatal Perineal Massage Practice for Pregnant Women
Title of the study (Brief title)	Investigation of the Effectiveness of Antenatal Perineal Massage Practice Educational Material for Pregnant Women
Region	Japan

Condition
Condition	Primiparous pregnant women
Classification by specialty	Obsterics and gynecology Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop a smartphone website supporting antenatal perineal massage practice and verify the usability for primiparous pregnant women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Continuation rate of antenatal perineal massage practice
Key secondary outcomes	1) Evaluation of antenatal perineal massage practice 2) Satisfaction with an effort during pregnancy period 3) Childbirth self-efficacy 4) The degree of perineal trauma following childbirth

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Smartphone website
Interventions/Control_2	Leaflet
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Correspond to all the following in recruitment for participants at 30-33 weeks of gestation. (1)The progress of pregnancy is well. (2)Pregnant women are primipara. (3)Pregnant women could read and write Japanese. (4)Pregnant women have smartphone.
Key exclusion criteria	Correspond to each the following in recruitment for participants at 30-33 weeks of gestation. (1) breech presentation (2) multiple pregnancy (3) Pregnant women are expected to deliver a baby by Caesarean section.
Target sample size	128

Research contact person
Name of lead principal investigator	Shoko Takeuchi
Organization	Yokohama City University
Division name	School of Medicine, Nursing Course
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2548
Email	shoko@yokohama-cu.ac.jp

Public contact
Name of contact person	Shoko Takeuchi
Organization	Yokohama City University
Division name	School of Medicine, Nursing Course
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2548
Homepage URL
Email	shoko@yokohama-cu.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	YAMAJI FUMIKO NURSING RESEARCH FUND
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 05 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 10 Day
Anticipated trial start date	2014 Year 04 Month 19 Day
Last follow-up date	2014 Year 10 Month 31 Day
Date of closure to data entry	2014 Year 11 Month 14 Day
Date trial data considered complete
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S1871519216000342
Results	1. Of the 161 women participants, 47 in the smartphone website group and 49 in the leaflet group completed all questionnaires. 2. Primary outcome was continuance rate (three times a week over a three week period) of antenatal perineal massage practice. The rates by a per protocol analysis were 51.1% in the smartphone website group and 51.0% in the leaflet group, respectively. There was no significant difference between the groups. Moreover, the rates by an intention to treat analysis were 29.6% in the smartphone website group and 31.3% in the leaflet group, respectively. There was also no significant difference between the groups. 3. There were no significant differences in the evaluation of perineal massage, childbirth self-efficacy, satisfaction with efforts towards childbirth, and perineal outcomes following childbirth which were measured as secondary outcomes between the groups.
Other related information

Management information
Registered date	2014 Year 05 Month 16 Day
Last modified on	2016 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016287