The Effect of Colic Massage and Kangaroo Care on Babies and Their Mothers (randomized)

December 5, 2024 updated by: Gulsah Sunay Ertem

Investigation of the Effects of Colic Massage and Kangaroo Care on Colicky Infants and Their Mothers

Background: Infantile colic is a condition characterized by inconsolable crying in infants under three months of age.

Purpose: The aim of this study is to determine the effects of colic massage and kangaroo care on infantile colic symptoms, crying, and sleep duration.

Method: Our study was conducted at the Child Health and Diseases Polyclinic of Atatürk city Hospital between March 2022 and April 2023. The study sample consisted of infants diagnosed with infantile colic who applied to the polyclinic and their mothers. 96 infants were randomly selected in our study using the randomization method. They were assigned to the massage, kangaroo care, and control groups. Infants in the colic massage and kangaroo care groups received interventions for 15-20 minutes in the morning and evening, while the control group received no intervention. Before the intervention, crying and sleep duration were monitored and recorded for 24 hours for one week in all three groups. Mothers continued the massage and kangaroo care application for 3 weeks. In the 3rd week of the application, 24-hour crying and sleep duration were recorded again for one week. Before and after the interventions, the Infantile Colic Scale (ICS) was applied to all three groups. The three groups were compared with the Wilcoxon test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data were collected from volunteer mothers of babies diagnosed with infantile colic who applied to the Child Health and Diseases outpatient clinic between March 2022 and February 2023 and who met the inclusion criteria for the study. The mothers were informed about the research through the "Informed Consent Form". Data were collected by the researcher through face-to-face interviews. The "Mother-Baby Information Form", "Infant Colic Scale", "Postpartum Specific Anxiety Scale", "Barkin Maternal Function Scale" and "Beck Depression Scale" were applied to the mothers in the massage, kangaroo care and control groups in the outpatient clinic before the intervention. They were then given the "Crying and Sleep Duration Form" and asked to fill it out at home for a week. Mothers who filled out the crying and sleep duration forms for a week were given an appointment for a home visit. The homes of these mothers were visited and the crying and sleep duration forms filled out for a week were collected. After collection, mothers were taught infantile colic massage and kangaroo care on a baby manikin according to randomization and were allowed to practice (The researcher has a "holistic infant massage certificate"). Mothers in the massage group applied colic massage according to the "Educational Colic Massage Checklist" for 15-20 minutes twice a day for three weeks when the baby was calm and during colic attacks. Mothers in the kangaroo care group applied kangaroo care according to the "Educational Kangaroo Care Checklist" for 15-20 minutes twice a day for three weeks when the baby was calm and during colic attacks. No intervention was made to the mothers in the control group. Mothers in all three groups filled out the "Crying and Sleep Duration Form" again for one week in the last week of the study. At the end of the study, the "Infantile Colic Scale", "Postpartum Specific Anxiety Scale", "Barkin Maternal Function Scale" and "Beck Depression Scale" were applied to the mothers in all three groups again (Mothers were supported with video calls and video recordings during the first massage and kangaroo care application and when needed). The study lasted four weeks in total and the intervention lasted three weeks.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altıeylül
      • Balıkesir, Altıeylül, Turkey, 10020
        • Ataturk City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Baby's Inclusion Criteria:

  • Diagnosed with infantile colic
  • Being born at term

Baby's Exclusion Criteria:

  • Lactose allergy,
  • Diagnosed with another chronic disease
  • Skin problem,
  • Weighing less than 2500 grams
  • Having congenital anomalies
  • Vomiting, constipation and malnutrition

Mothers' inclusion criteria

  • being a volunteer
  • being literate and
  • having a smart phone.

Mothers' exclusion criteria

  • using incorrect massage and kangaroo care
  • using other traditional and medical treatments during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: massage group
Colic massage is applied to babies with infantile colic
Behavioral: massage
The mothers in the massage group applied colic massage according to the "Educational Colic Massage Checklist" twice a day for 15-20 minutes each time for three weeks, when the baby was calm and during colic attacks.
Experimental: kangaroo care group
Kangaroo care is applied to babies with infantile colic
Behavioral: kangroo care
The mothers in the kangaroo care group applied kangaroo care according to the "Educational Kangaroo Care Checklist" twice a day for three weeks for 15-20 minutes each time when the baby was calm and during colic attacks.
No Intervention: control group
No intervention is applied to babies with infantile colic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infantile scale scores
Time Frame: up to 3 weeks
The Infantile Colic Scale consists of 19 questions. The scale has 5 subscales: Cow's Milk/Soy Protein Allergy/Intolerance, Immature Gastrointestinal System, Immature Central Nervous System, Difficult Infant Temperament, Parent-Infant Interaction, and Problematic Infant. Scale items are rated on a Likert-type scale ranging from 1 to 6. Ratings range from 1 (strongly disagree) to 6 (strongly agree). Negative questions were reverse-coded for interpreting the scores. Item 3 in the immature gastrointestinal system subscale, items 7, 8, and 9 in the immature central nervous system subscale, items 13, 14, and 15 in the difficult infant temperament subscale, and items 17 and 19 in the parent-infant interaction and problematic infant subscales were reverse-coded.Data are expressed as mean ± SD and median (minimum: maximum).
up to 3 weeks
mothers' postpartum anxiety scores
Time Frame: up to 3 weeks
The Postpartum Specific Anxiety Inventory consists of 51 items. Responses to the items are rated on a 4-point Likert scale ranging from 1 to 4 (1=never, 2=sometimes, 3=usually, 4=always). The total score for the level of postpartum anxiety is; below 73 points is considered low risk, between 74 and 100 points is considered moderate risk, and above 101 points is considered high risk. The lowest possible score is 51, and the highest score is 204. 8 The scale has four subscales: Items 1-15 assess maternal adequacy and attachment concerns, items 16-26 assess infant safety and well-being concerns, items 27-33 assess practical infant care concerns, and items 34-51 assess psychosocial adjustment to motherhood.
up to 3 weeks
mother's depression scores
Time Frame: up to 3 weeks
The scale consists of 21 items related to depressive symptoms such as pessimism, sense of failure, dissatisfaction, guilt, restlessness, fatigue, decreased appetite, indecisiveness, sleep disorders, and social withdrawal. The total score that can be obtained from the scale varies between 0-63. Those who scored 17 and above were accepted as 'depressive symptoms' as 10. The Turkish validity and reliability studies of the BDI were conducted by Teğin in 1980 and by Hisli in 1989, and the Cronbach alpha value was found to be 0.80. The BDI scoring for the severity of depression is interpreted as 0-9 = Minimal, 10-16 = Mild, 17-29 = Moderate, 30-63 = severe, depression. It takes approximately 15 minutes to complete the scale. However, this time may vary depending on the patient's level of education and whether or not they have obsessive characteristics.
up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal function scores.
Time Frame: up to 3 weeks
The scale's self-care dimension was calculated as 0.66, maternal psychology sub-dimension as 0.71, baby care sub-dimension as 0.62, social support sub-dimension as 0.69, and adaptation to motherhood sub-dimension as 0.50. The responses on the scale are numbered from 0 to 6. 0 is expressed as "completely disagree", 1 as "disagree", 2 as "somewhat disagree", 3 as "undecided", 4 as "somewhat agree", 5 as "agree", and 6 as "completely agree". The lowest score that can be obtained in the scoring of the scale is 0, and the highest score is 96. It is accepted that the functional status increases as the scores increase. BAFÖ is applied to mothers with babies younger than 18 months.
up to 3 weeks
colic babies crying and sleeping time
Time Frame: up to 3 weeks
It is a form created by the researcher in which infants' daily crying and sleep durations can be recorded at every hour of the day and on every day of the week.
up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulsah Sunay Ertem

Investigators

  • Study Director: nurcan özyazıcıoğlu, professor, Bursa Uludağ Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Actual)

February 22, 2023

Study Completion (Actual)

February 22, 2023

Study Registration Dates

First Submitted

November 23, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-25691463-900-35292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. doctora thesis
    Information identifier: The effectiveness of massage
  2. article
    Information identifier: Survey in efficacy of probioti
  3. article
    Information identifier: Kangaroo mother care
  4. article
    Information identifier: Effectiveness of massage
  5. article
    Information identifier: The effect of massage
  6. rewiev
    Information identifier: 0-1 Yaş Arası Bebekler
  7. Guide
    Information identifier: kangroo care guide
  8. doctora thesis
  9. article
    Information identifier: The Effects of Kangaroo Mother
  10. article
    Information identifier: efficacy of probiotic
  11. article
    Information identifier: Kangaroo mother care for infan
  12. article
    Information identifier: Effect of massage
  13. doctora thesis
    Information identifier: The Effect of Aromatherapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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