NCT05302427

Brief Summary

Touch is an essential element in the healthy growth and development of the baby. Infant massage is the best way to touch babies. In line with the literature review on the subject, it has been reported that infant massage supports growth and development in infants, improves attachment between mothers and babies and decreases the level of depression and anxiety in mothers. With the coronavirus pandemic, quarantine decisions have been implemented all over the world. In addition to the stress brought on by their new roles, new mothers have to cope with the anxiety and stress of being a parent and babysitting during the pandemic period. During the pandemic process, it is seen that depression and anxiety levels increase in mothers who have given birth, and maternal attachment is negatively affected. Depression and anxiety in mothers negatively affect the cognitive, physical, social and emotional development of babies. It is very important to encourage practices that increase mother-infant interaction, such as infant massage, during the pandemic period. The universe of the research will consist of mothers and their babies who were followed up in İzmir Karşıyaka No. 8 Gülay Kaymak Family Health Center and Karşıyaka No. 4 Bostanlı-2 Family Health Center between May 2021 and May 2022. The sample of the study is 38-42. It is planned to create babies born in the 4th week of pregnancy, with a birth weight of over 2500 grams and who have completed their fourth week (one month old) (n:60).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1 day

First QC Date

March 11, 2022

Last Update Submit

June 27, 2022

Conditions

GrowthAttachmentSelf-Confidence

Outcome Measures

Primary Outcomes (17)

  • Maternal Attachment Inventory (MAI)

    The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (pre-intervention assessment)

    end of week 4

  • Maternal Attachment Inventory (MAI)

    The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (post-intervention assessment)

    end of week 20

  • Growth Parameter

    The mean of baseline weight (in grams)

    end of week 4

  • Growth Parameter

    The mean change in body weight from end of week 4 to end of week 8 (in grams)

    end of week 8

  • Growth Parameter

    The mean change in body weight from end of week 8 to end of week 12 (in grams)

    end of week 12

  • Growth Parameter

    The mean change in body weight from end of week 12 to week end of 16 (in grams)

    end of week 16

  • Growth Parameter

    The mean change in body weight from end of week 16 to week end of 20 (in grams)

    end of week 20

  • Growth Parameter

    The mean of baseline body length (in centimeters)

    end of week 4

  • Growth Parameter

    The mean change in body length from end of week 4 to end of week 8 (in centimeters)

    end of week 8

  • Growth Parameter

    The mean change in body length from end of week 8 to end of week 12 (in centimeters)

    end of week 12

  • Growth Parameter

    The mean change in body length from end of week 12 to end of week 16 (in centimeters)

    end of week 16

  • Growth Parameter

    The mean change in body length from end of week 16 to end of week 20 (in centimeters)

    end of week 20

  • Head circumference

    The mean of baseline head circumference (in centimeters)

    end of week 4

  • Head circumference

    The mean change in head circumference from end of week 4 to end of week 8 (in centimeters)

    end of week 8

  • Head circumference

    The mean change in head circumference from end of week 8 to end of week 12 (in centimeters)

    end of week 12

  • Head circumference

    The mean change in head circumference from end of week 12 to end of week 16 (in centimeters)

    end of week 16

  • Head circumference

    The mean change in head circumference from end of week 16 to end of week 20 (in centimeters)

    end of week 20

Secondary Outcomes (2)

  • Pharis Self-Confidence

    end of week 4

  • Pharis Self-Confidence

    end of week 20

Study Arms (2)

Massage group

EXPERIMENTAL

The massage group will be shown live one-to-one baby massage training via Microsoft Teams by the researcher, and the mother will be asked to apply it to her baby at the same time. Baby massage training; It consists of leg massage, face-abdominal massage, arm-chest massage and back massage and will be completed in four weeks.

Behavioral: Infant Massage

Control group

NO INTERVENTION

Infant massage training will not be given to the mothers of the babies in the control group until the 20th week.

Interventions

Infant MassageBEHAVIORAL

The training will start with a leg massage in the first session and the mother will be asked to do this once a day until the next lesson. The next week, the new massage movement will be shown to the mother and the training will continue, and the mother will be told to do the application throughout the week by integrating it with the previous movement this time, and the four-week training will be completed in this way. After the training, which massage movement was taught to the mothers every week, the application pictures of this part will be sent and at the end of the four-week training, the baby massage video and the baby massage guide will be sent to the mothers by e-mail.

Massage group

Eligibility Criteria

Age4 Weeks - 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The mother knows how to read, write and use a computer,
  • The mother's consent to participate in the study,
  • Babies 38-42. to be born at the gestational week and to have a birth weight of over 2500 grams and to have completed the fourth week.

You may not qualify if:

  • Multiple pregnancy
  • The mother has a disease or disability that prevents her from massaging her baby.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karşıyaka 4 No'lu Bostanlı- 2 Aile Sağlığı Merkezi

Izmir, Karşıyaka, Turkey (Türkiye)

Location

Karşıyaka 8 Nolu Gülay Kaymak Aile Sağlığı Merkezi

Izmir, Karşıyaka, Turkey (Türkiye)

Location

Related Publications (4)

  • Vicente S, Verissimo M, Diniz E. Infant massage improves attitudes toward childbearing, maternal satisfaction and pleasure in parenting. Infant Behav Dev. 2017 Nov;49:114-119. doi: 10.1016/j.infbeh.2017.08.006. Epub 2017 Sep 1.

    PMID: 28866286RESULT

  • Gurol A, Polat S. The Effects of Baby Massage on Attachment between Mother and their Infants. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Mar;6(1):35-41. doi: 10.1016/j.anr.2012.02.006. Epub 2012 Mar 10.

    PMID: 25030689RESULT

  • Lu LC, Lan SH, Hsieh YP, Lin LY, Chen JC, Lan SJ. Massage therapy for weight gain in preterm neonates: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2020 May;39:101168. doi: 10.1016/j.ctcp.2020.101168. Epub 2020 Apr 1.

    PMID: 32379694RESULT

  • Ercelik ZE, Yilmaz HB. Effectiveness of infant massage on babies growth, mother-baby attachment and mothers' self-confidence: A randomized controlled trial. Infant Behav Dev. 2023 Nov;73:101897. doi: 10.1016/j.infbeh.2023.101897. Epub 2023 Nov 6.

    PMID: 37939520DERIVED

Related Links

Study Officials

  • Zübeyde Ezgi ERCELIK, MSc

    Bandırma Onyedi Eylül University

    STUDY CHAIR

  • Hatice BAL YILMAZ, Proffessor

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 31, 2022

Study Start

November 29, 2021

Primary Completion

November 30, 2021

Study Completion

June 17, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)