CClinicalTrials.gg
CompletedNCT06136520Updated Oct 29, 2024

The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression

An interventional study of Baby massage in Baby Massage and Postpartum Depression, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Baby Massage
  • Postpartum Depression

Keywords

  • Postpartum Depression
  • baby massage
  • attachment
03

In context

Depression, Postpartum

529 studies on the registry are indexed under Depression, Postpartum; 125 are open to participants now.

This study's enrollment of 54 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • ● 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    experimental group

    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

  • No intervention
    Control group

    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

  • BehavioralBaby massage

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

07

Study locations

1 site
  • Betül Uncu
    Istanbul, 34320, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06136520
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Betul Uncu (Principal Investigator, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Nov 18, 2023
Start date
Oct 26, 2023
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024
Last update
Oct 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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