NCT06377176

Brief Summary

Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

March 4, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

Massage TherapyPostpartum DepressionStressFatigueInfant Temperament

Outcome Measures

Primary Outcomes (1)

  • Depression

    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 Outcomes (3)

  • 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

    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

    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.

Study Arms (2)

Intervention group

EXPERIMENTAL

Massage therapy for mother and infant.

Other: Massage therapy

Control group

NO INTERVENTION

the control group received standard care.

Interventions

the intervention group underwent ten sessions of twice-weekly mother and infant massage therapy for five weeks.

Intervention group

Eligibility Criteria

Age1 Month - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Drug abuse history.
  • Bipolar.
  • Schizophrenia history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Health Center

Sleman, Special Region of Yogyakarta, 55584, Indonesia

Location

MeSH Terms

Conditions

Depression, PostpartumFatigue

Interventions

Massage

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2024

First Posted

April 22, 2024

Study Start

June 16, 2021

Primary Completion

October 3, 2021

Study Completion

October 3, 2021

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations