UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053456 |
|---|---|
| Receipt number | R000061010 |
| Scientific Title | Effects of early postpartum massage on feeding, emotions, and discomfort symptoms |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2025/05/16 10:01:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of early postpartum massage on feeding, emotions, and discomfort symptoms
Acronym
Effects of early postpartum massage on feeding, emotions, and discomfort symptoms
Scientific Title
Effects of early postpartum massage on feeding, emotions, and discomfort symptoms
Scientific Title:Acronym
Effects of early postpartum massage on feeding, emotions, and discomfort symptoms
Region
| Japan |
Condition
Condition
Postpartum
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find out whether massage for postpartum women in the early postpartum period is effective in reducing feeling, emotions, and postpartum discomfort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in "depression" scores on the Japanese version/shortened version of POMS2 before and after massage in the intervention group and before and after rest in the target group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A 40-minute massage of the upper body, lower limbs, and head will be performed on the second postpartum day, and feeling/emotions and discomfort symptoms will be investigated before and after.
Interventions/Control_2
n the second postpartum day, the patient will lie in bed for 40 minutes, and their feeling/emotions and discomfort symptoms will be investigated before and after
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Currently hospitalized at Nara Medical University Hospital
After vaginal delivery
Postpartum 2nd day
Those who have given consent to the research obstetrics department through written and oral explanations
Key exclusion criteria
Unable to read or write Japanese
Have a mental illness being treated
I have a bone/muscular disease
Those who have been judged by their doctor or midwife to be burdensome to participate in the study due to complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Yamasaki |
Organization
Nara Medical University
Division name
Department of Nursing, Faculty of Medicine
Zip code
6348521
Address
840 Shijo-cho, Kashihara City, Nara
TEL
0744223051
ai.y.309@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Yamasaki |
Organization
Nara Medical University
Division name
Department of Nursing, Faculty of Medicine
Zip code
6348521
Address
840 Shijo-cho, Kashihara City, Nara
TEL
0744223051
Homepage URL
ai.y.309@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Prefectural Medical University
Address
840 Shijo-cho, Kashihara City, Nara
Tel
0744223051
ai.y.309@naramed-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | 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
100
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
| 2024 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061010
