- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06377176
Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament
Massage Therapy for Infants and Mothers
Study Overview
Detailed Description
Data collection procedures Preparation stage Two research assistants with a master's degree in midwifery and two years of clinical experience were chosen by the researcher. The researcher describes and discusses the purpose, intervention protocol, research instrument, and COVID-19 protocol of the study. All research assistants as data collectors and the therapist are required to have received either two doses of the COVID-19 vaccine or a handwash or hand sanitizer, in addition to wearing a face mask. Furthermore, the research assistant requested to accompany the researcher as they conducted the informed consent and questionnaire administration process with the participant on an estimated three separate occasions. The research assistant conducted an informed consent test on the participants after three observations; individuals who adequately showcased their ability were granted employment as research assistants. Daily activity logs must be included on self-report forms completed by the research assistant.
Additionally, the researcher designates the mother and infant massage therapist; for the baby massage, the researcher collaborates with a physiotherapist and midwives who possess more than two years of clinical experience and a midwife who holds certification in baby massage therapy. Following this, the massage therapist and researcher demonstrated and discussed the massage technique with the mother and child. During the intervention, the researcher additionally provided the mothers with a baby doll so that they could serve as models for baby massage to the mothers while the physiotherapists or midwives attended to the infants. Upon the conclusion of the intervention, the mothers would be capable of performing massage independently.
Implementation stage The researcher employed the EPDS questionnaire as a screening tool to identify postpartum mothers for depression; participants were chosen based on their EPDS score of 13. Following this, the investigator proceeds to deliver an elucidation of the study's aims and methodology to the participant. On the day of the questionnaire's initiation, the consent form is duly signed by the respondent. The research assistant confirmed the questionnaire's completion upon its return and requested that the respondents complete it, including the respondent code, and place it in the file holder.
Following the completion of the initial questionnaires by both groups during the meeting, the intervention group underwent ten sessions of twice-weekly mother and infant massage therapy over the course of five weeks. The mother promptly resubmits the questionnaires following the conclusion of the newborn massage therapy. A month later, the mother proceeds to complete the remaining questionnaires.
A regimen for the respondent and therapist to receive massages was formulated by the researcher. The receiver dictates the duration of the massage. The researcher then created a massage regimen to be executed twice weekly for five weeks. Respondents 1 through 30 adhered to a Monday through Thursday routine, but those 31 through 52 observed Tuesday through Friday. Four to six participants were massaged per therapist, and a total of seven therapists were hired. The massage hours of operation are from 7:00 am to 5:00 pm. A two-hour period separated each responder; for instance, in the scenario where one respondent received a massage at 7:00 am, the subsequent respondent would receive one at 9:00 am.
The control group is administered standard care or routine mother and infant care. As part of usual care, the CHC midwife conducts routine assessments of the infant's height and weight, in addition to furnishing the mother with relevant information. Furthermore, after completing the second posttest, mother and infant massage therapy is implemented for the control group.
Sample size This research uses G-power calculation to examine the number of samples needed. Based on the G-power calculation and the assumption of a minimum medium effect size of 0.25% at a significance level of 0.05 and 80% power, an estimated sample size of 86 participants is necessary. Considering a 20 percent attrition rate, 104 individuals were recruited in total. By utilizing convenience sampling, this research incorporates all eligible participants. Two participants were ineligible to participate in this research due to a family-related concern.
Data analysis The data was analyzed by univariate, bivariate, and multivariate. Bivariate statistics using independent t-tests, Chi-square, Fisher exact test, Pearson correlation; and for the multivariate data using generalized estimated equation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yogyakarta
-
Sleman, Yogyakarta, Indonesia, 55584
- Community Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Edinburgh Postnatal Depression Scale (EPDS) score more and equal to 13.
- Must be able to read.
- All types of delivery.
- Full-term gestation.
- Healthy infant.
Exclusion Criteria:
- Drug abuse history.
- Bipolar.
- Schizophrenia history.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Massage therapy for mother and infant.
|
the intervention group underwent ten sessions of twice-weekly mother and infant massage therapy for five weeks.
|
|
No Intervention: Control group
the control group received standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
Score of mother depression on postpartum.
EPDS score greater than or equal to 13.
|
Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress
Time Frame: Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
The score of mother's stress.
PSS-14 score range from 0-56.
High scores indicate more stress.
|
Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
|
Fatigue
Time Frame: Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
The score of mothers fatigue.
Fatigue scores range from 0-10.
High Scores indicate more fatigue.
|
Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
|
Infant temperament
Time Frame: Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
The score of infant temperament.
Infant temperament score 0-3.
High scores indicate as a difficult temperament.
|
Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTUNHSEN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
Women and Infants Hospital of Rhode IslandNot yet recruitingPostpartum Anxiety | Paternal Postpartum Depression
-
Bekelu Teka WorkuJimma UniversityNot yet recruitingPrenatal Depression | Mental Health Related Quality of Life | Maternal Postpartum Depression | Paternal Postpartum DepressionEthiopia
-
Jordan University of Science and TechnologyActive, not recruitingPostpartum Depression | Postpartum Depression (PPD)Jordan
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Afyonkarahisar Health Sciences UniversityNot yet recruitingPostpartum Depression | Postpartum Anxiety
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
Clinical Trials on Massage therapy
-
Cardenal Herrera UniversityCompleted
-
University of ThessalyUniversity of NicosiaCompleted
-
University of British ColumbiaRegistered Massage Therapists Association of British ColumbiaCompleted
-
Universidad de LeónCompletedPremature Birth | Premature Infant | Massage | Preterm Infant
-
Centennial CollegeStollery Children's Hospital; SickKids Foundation; Canadian Institute of Natural...UnknownDepression | Stress | Anxiety | Pediatric CancersCanada
-
George Washington UniversityCompletedPrematurityUnited States
-
Mayo ClinicRecruiting
-
Wroclaw University of Health and Sport SciencesRecruiting
-
MetroHealth Medical CenterCompletedPain | Breast Surgery | Shoulder Mobility Impairment | Postmastectomy Lymphedema SyndromeUnited States
-
Centre hospitalier de l'Université de Montréal...Completed