Clinical trial NCT06727760: The Effect of Colic Massage and Kangaroo Care on Babies and Their Mothers
Official title: Investigation of the Effects of Colic Massage and Kangaroo Care on Colicky Infants and Their Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colic, Infantile
Crying Time in Colicky Infants
Postpartum Depression
Postpartum Anxiety
Motherhood
Keywords: colic
cangroo care
crying and sleeping duration
nursing education
postpartum anxiety
postpartum depression
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: infantile scale scores
timeFrame: up to 3 weeks
measure: mothers' postpartum anxiety scores
timeFrame: up to 3 weeks
measure: mother's depression scores
timeFrame: up to 3 weeks
Secondary outcomes:
measure: maternal function scores.
timeFrame: up to 3 weeks
measure: colic babies crying and sleeping time
timeFrame: up to 3 weeks
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Ataturk City Hospital
state: Altıeylül
Study officials:
affiliation: bursa uludağ üniversitesi
name: nurcan özyazıcıoğlu, professor
role: STUDY_DIRECTOR
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