NCT06136520

Brief Summary

The research to be conducted within the scope of the project will be randomized controlled, and the population of the research will be primiparous pregnant women reached through social media. Primiparous pregnant women in the 32nd - 40th weeks of pregnancy will be included in the study, and the sample size is determined by using the G\*Power (3.1.9.2) program, considering a margin of error of 0.05 and data loss, with a power of 95% and a medium effect size; 27 people should be included in the experimental (baby massage) group and 27 people in the control group. In determining the groups, participants will be assigned to experimental and control groups using the "Randomizer.org" program. Pregnant women included in the research will be informed about the study and will be presented with an "Informed Consent Form" and "Voluntary Consent Form". Baby massage training will be given to the experimental group, and a reminder training will be given 2 weeks later. "Personal Information Form", "Prenatal Attachment Inventory" and "Beck Depression Inventory" will be applied to both groups at the beginning of the study, and postpartum 30-42 weeks. and 60-72. "Maternal Attachment Scale" and "Edinburg Postpartum Depression Scale" will be administered between days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

First Submitted

Initial submission to the registry

October 26, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 29, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

October 26, 2023

Last Update Submit

October 24, 2024

Conditions

Keywords

Postpartum Depressionbaby massageattachment

Outcome Measures

Primary Outcomes (2)

  • the Maternal Attachment Scale (mother-baby bonding scale)

    Postpartum ages 30-42 in the Maternal Attachment Scale "Experimental Group". days and 60-72. It will be applied to mothers between days. Postpartum ages 30-42 are in the "Control Group" of the Maternal Attachment Scale. days and 60-72. It will be applied to mothers between days. Measures maternal feelings and behaviors that show love The lowest score obtained from the scale is 26, the highest score is 104, and a high score indicates high maternal attachment.

    3 months

  • The Edinburgh Postpartum Depression Scale

    The Edinburgh Postpartum Depression Scale will be used to evaluate and monitor the postpartum depression development levels of the groups. The cut-off score of the scale is 12/13, and women who score above 13 are considered to be at risk for depression.

    3 months

Study Arms (2)

experimental group

EXPERIMENTAL

After the first measurements are made and the groups are determined; "Personal Information Form", "Perinatal Attachment Inventory" and "Beck Depression Inventory" will be applied to the experimental and control groups. Pregnant women in the experimental group were 32-40 weeks of pregnancy. After baby massage training is given, 30-42 weeks after birth. between days and 60-72. "Maternal Attachment Scale" and "Edinburgh Postpartum Depression Scale" will be applied to the experimental and control groups on the following days. The control group will receive standard care while the experimental group receives training. After the second postpartum data of the pregnant women in the control group are collected, a 30-minute baby massage training will be given by the researcher.

Behavioral: Baby massage

Control group

NO INTERVENTION

The control group will receive standard care while the experimental group receives training. After the second postpartum data of the pregnant women in the control group are collected, a 30-minute baby massage training will be given by the researcher.

Interventions

Baby massageBEHAVIORAL

After the first measurements are made and the groups are determined; "Personal Information Form", "Perinatal Attachment Inventory" and "Beck Depression Inventory" will be applied to the experimental and control groups. Pregnant women in the experimental group were 32-40 weeks of pregnancy. After baby massage training is given, 30-42 weeks after birth. between days and 60-72. "Maternal Attachment Scale" and "Edinburgh Postpartum Depression Scale" will be applied to the experimental and control groups on the following days. The control group will receive standard care while the experimental group receives training. After the second postpartum data of the pregnant women in the control group are collected, a 30-minute baby massage training will be given by the researcher.

experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-35, Being primiparous and having a singleton pregnancy,
  • No high-risk pregnancy,
  • Being in the 32nd to 40th week of pregnancy,
  • Being literate and knowing and understanding Turkish,
  • Pregnant women who have internet access and knowledge of internet usage.

You may not qualify if:

  • ● Presence of chronic disease,
  • Pregnancy with congenital malformation,
  • Unwanted pregnancy,
  • Having attended a pregnancy school,
  • Women who become pregnant as a result of assisted reproductive technology,
  • Those with hearing and vision problems,
  • Having a known serious psychiatric disease diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betül Uncu

Istanbul, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 18, 2023

Study Start

October 26, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

October 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations