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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013979
Receipt No. R000016287
Scientific Title The development and Evaluation of Smartphone Website Supporting Antenatal Perineal Massage Practice for Pregnant Women
Date of disclosure of the study information 2014/05/16
Last modified on 2016/05/16

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Basic information
Public title The development and Evaluation of Smartphone Website Supporting Antenatal Perineal Massage Practice for Pregnant Women
Acronym Investigation of the Effectiveness of Antenatal Perineal Massage Practice Educational Material for Pregnant Women
Scientific Title The development and Evaluation of Smartphone Website Supporting Antenatal Perineal Massage Practice for Pregnant Women
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Shoko Takeuchi
Organization Yokohama City University
Division name School of Medicine, Nursing Course
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2548
Email shoko@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoko Takeuchi
Organization Yokohama City University
Division name School of Medicine, Nursing Course
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S1871519216000342
Number of participants that the trial has enrolled
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.
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 Main results already published
Date of protocol fixation
2014 Year 04 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000016287

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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