UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050065 |
|---|---|
| Receipt number | R000056562 |
| Scientific Title | Effect of Telenursing (SMART MAMA) on Postpartum Depression, Anxiety and Maternal Infant Bonding among Women during Postnatal Period |
| Date of disclosure of the study information | 2023/01/19 |
| Last modified on | 2025/01/29 22:22:06 |
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Basic information
Public title
Effect of Telenursing (SMART MAMA) on Postpartum Depression, Anxiety and Maternal Infant Bonding among Women during Postnatal Period
Acronym
Effect of Telenursing on Postpartum Depression, Anxiety and Maternal Infant Bonding
Scientific Title
Effect of Telenursing (SMART MAMA) on Postpartum Depression, Anxiety and Maternal Infant Bonding among Women during Postnatal Period
Scientific Title:Acronym
Effect of Telenursing on Postpartum Depression, Anxiety and Maternal Infant Bonding
Region
| Japan |
Condition
Condition
Postpartum Depression
Classification by specialty
| Psychosomatic Internal Medicine | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to reduce postpartum depressive symptoms and the level of anxiety and enhance maternal-infant bonding Among women during the postnatal period
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postpartum depressive symptoms measured by the Edinburgh Postnatal Depression Scale score at the baseline and 12 months after the intervention.
Key secondary outcomes
The level of anxiety measured by the State-Trait Anxiety Inventory, and maternal-infant bonding measured by the Mother-to-Infant Bonding Scale.
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 not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention 1: The intervention provides information via a smartphone application named SMART MAMA for 12 weeks. The women download the application at the time of the baseline survey, and they can access it anytime. The intervention will be composed of physical, psychological, and informational support. Physical support intervention will teach women to apply stretching and Kegel exercises. At the same time, the psychological support will include mindfulness and muscle relaxation techniques. Besides, informational support provides the women with information about postpartum depression signs and symptoms and infant maternal bonding for 12 weeks. The application has two components. First, it provides videos, photos, and written information for learning. Second, it provides notification messages to increase the women's attention, encouragement, and motivation.
Interventions/Control_2
Intervention 2: The control provides standard routine postnatal care provided clinic, which generally includes nursing care during the hospitalization, such as observation of postpartum physical recovery, breastfeeding support, and support for childcare techniques like changing diapers and bathing. Also, it includes 2-week and 1-month checkups after discharge.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Women in the postpartum period with full-term delivery.
2. Age about 18 and above years old.
3. Free from any mental or psychiatric disorders, including alcohol or substance abuse
4. Having no obstetric diseases (eclampsia and placenta previa., etc.)
5. Able to use the app on a smartphone for the study
Key exclusion criteria
1. Having serious underlying disease, including autoimmune disease.
2. Had complicated 4th-degree perineal tear.
3. Have delivered a newborn with an apparent congenital anomaly.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Hiroshima University
Division name
Global Health Nursing, Department of Nursing Science, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5345
yokoshim@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Hiroshima University
Division name
Global Health Nursing, Graduate School of Biomedical and Health Science
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5345
Homepage URL
yokoshim@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Yoko Shimpuku
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitamura Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
Tel
082-257-5908
iryo-seisaku@office.hiroshima-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
北村医院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 19 | 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
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056562
