UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052795 |
|---|---|
| Receipt number | R000060247 |
| Scientific Title | Effects of early postpartum massage on mood, emotions, and discomfort symptoms |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2023/11/14 11:28:05 |
* 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 mood, emotions, and discomfort symptoms
Acronym
Effects of early postpartum massage on mood, emotions, and discomfort symptoms
Scientific Title
Effects of early postpartum massage on mood, emotions, and discomfort symptoms
Scientific Title:Acronym
Effects of early postpartum massage on mood, 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 given to postpartum women in the early postpartum period is effective in reducing mood, emotions, and postpartum discomfort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 Japanese/shortened version "Depression" score within 1 hour before and after massage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
On the second postpartum day, participants will receive a 40-minute massage and answer questions before and after the massage.
The massage covers the upper body (face wash, facial lymphatic massage, front chest, arms, shoulder blades, back), lower limbs (lymphatic massage from ankles to knees, acupuncture point stimulation on ankles and soles, warm towel method),and this including a head massage.
Interventions/Control_2
On the second postpartum day, participants will take a 40-minute rest and answer questions before and after the rest. The same massage as in the intervention group will be performed from the 3rd postpartum day onwards.
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
Post- puerperal woman admitted to Ward E5 of Nara Medical University Hospital after vaginal delivery
Persons over 18 years old
Postpartum 2nd day
Those who have consented to participate in the research through written and oral explanations
Key exclusion criteria
Persons who are unable to read or write Japanese
Persons with mental illness undergoing treatment
Persons with bone/muscular diseases
Persons who are judged by the ward 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 Prefectural 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 Prefectural 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 Prefectural Medical University
Institute
Department
Personal name
Toshihko igarashi
Funding Source
Organization
Nara Prefectural Medical University Maternity Nursing Area
Course research expenses
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
奈良県立医科大学附属病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060247
