UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058439 |
|---|---|
| Receipt number | R000065871 |
| Scientific Title | Development of a Nursing Support Program for Primiparous Women to Regulate Sleep-Wake Rhythm up to Two Months Postpartum |
| Date of disclosure of the study information | 2025/07/12 |
| Last modified on | 2025/07/12 11:21:23 |
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Basic information
Public title
Development of a Nursing Support Program for Primiparous Women to Regulate Sleep-Wake Rhythm up to Two Months Postpartum
Acronym
Development of a Nursing Support Program for Primiparous Women to Regulate Sleep-Wake Rhythm up to Two Months Postpartum
Scientific Title
Development of a Nursing Support Program for Primiparous Women to Regulate Sleep-Wake Rhythm up to Two Months Postpartum
Scientific Title:Acronym
Development of a Nursing Support Program for Primiparous Women to Regulate Sleep-Wake Rhythm up to Two Months Postpartum
Region
| Japan |
Condition
Condition
Healthy primiparous women
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to develop a nursing support program for primiparous women to improve their sleep quality primarily by regulating the sleep-wake rhythm and to demonstrate the effectiveness of the program when administered to primiparous women during pregnancy and up to 2 months postpartum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J) was assessed at 2,4,and 8 weeks postpartum.
Key secondary outcomes
Sleep quantity was assessed by measuring the total sleep times of mothers and infants, the total number and duration of wakes after sleep onset (WASO) for both groups, the number and duration of naps,maternal sleep efficiency, and bedtimes and getting-up times of mothers and infants.Sleep quality was assessed using the Japanese version of the Epworth Sleepiness Scale (JESS).Sleep quantity was assessed at 2 and 8 weeks postpartum, while sleep quality was assessed at 2, 4, and 8 weeks postpartum.Outcome measures consisted of the Postpartum Maternal Confidence Scale(PMCS), the Postpartum Maternal Satisfaction Scale (PMSS), and adherence to a 28-item self-care questionnaire regarding postpartum sleep.The outcome measures were also assessed at the same points as sleep quality (2, 4, and 8 weeks postpartum), with the exception of self-care adherence in the control group, which was assessed only at 8 weeks postpartum.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We developed a program based on Orem's Self-care Theory to support women juggling dual roles in self-care and dependent care for their infants to practice self-care for sleep. The program was administered to the individual participants twice between 28 and 36 weeks of pregnancy and once each at 2 weeks and 1 month postpartum. In the first program session during pregnancy, we provided information on how to induce sleep in the postpartum period, the sleep characteristics of infants, and postpartum daily life schedules. In addition, we asked the participants to discuss their postpartum daily life routines with their families. In the second session, we provided the participants with instructions and a practice session on breastfeeding using a doll. In addition, we reviewed their discussions with their families about their postpartum daily living. During the two sessions after childbirth, we assessed the sleep and breastfeeding status of the participating mothers so that we could provide nursing care to enable them to practice self-care for sleep and breastfeeding.
Interventions/Control_2
Standard of 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Between 28 and 32 weeks of their first pregnancy women
Key exclusion criteria
Women who are receiving psychiatric, neurological or psychosomatic treatment during pregnancy.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | KANAKO |
| Middle name | |
| Last name | MATSUEDA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Nursing Department, Nursing Division
Zip code
5690095
Address
7-6 Hachicho, Takatsuki City, Osaka Prefecture, Japan
TEL
0726831221
kanako.matsueda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | KANAKO |
| Middle name | |
| Last name | MATSUEDA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Nursing Department, Nursing Division
Zip code
5690095
Address
7-6 Hachicho, Takatsuki City, Osaka Prefecture, Japan
TEL
0726831221
Homepage URL
kanako.matsueda@ompu.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
kanako matsueda
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Hyogo
Address
13-71 Kitaouji-cho, Akashi-shi, Hyogo, Japan
Tel
078-925-0860
kenkyurinri_iinkai@cnas.u-hyogo.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 12 | 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
110
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 | 07 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065871
