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

NCT ID: NCT06727760

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2023-02-22

Brief Summary

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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

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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.

Conditions

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Colic, Infantile Crying Time in Colicky Infants Postpartum Depression Postpartum Anxiety Motherhood

Keywords

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colic cangroo care crying and sleeping duration nursing education postpartum anxiety postpartum depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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massage group

Colic massage is applied to babies with infantile colic

Group Type EXPERIMENTAL

massage

Intervention Type BEHAVIORAL

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.

kangaroo care group

Kangaroo care is applied to babies with infantile colic

Group Type EXPERIMENTAL

kangroo care

Intervention Type BEHAVIORAL

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.

control group

No intervention is applied to babies with infantile colic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with infantile colic
* Being born at term


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

Exclusion Criteria

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


* using incorrect massage and kangaroo care
* using other traditional and medical treatments during the study.
Minimum Eligible Age

3 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulsah Sunay Ertem

OTHER

Sponsor Role lead

Responsible Party

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Gulsah Sunay Ertem

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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nurcan özyazıcıoğlu, professor

Role: STUDY_DIRECTOR

bursa uludağ üniversitesi

Locations

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Ataturk City Hospital

Balıkesir, Altıeylül, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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O'Higgins M, St James Roberts I, Glover V. Postnatal depression and mother and infant outcomes after infant massage. J Affect Disord. 2008 Jul;109(1-2):189-92. doi: 10.1016/j.jad.2007.10.027. Epub 2007 Dec 20.

Reference Type BACKGROUND
PMID: 18086500 (View on PubMed)

Onozawa K, Glover V, Adams D, Modi N, Kumar RC. Infant massage improves mother-infant interaction for mothers with postnatal depression. J Affect Disord. 2001 Mar;63(1-3):201-7. doi: 10.1016/s0165-0327(00)00198-1.

Reference Type BACKGROUND
PMID: 11246096 (View on PubMed)

Lotfalipour B, Tirgari B, Pouraboli B, Mirzaee M. Effect of Preterm Infant Massage by the Mother on the Mood of Mothers Having Preterm Infants. J Chiropr Med. 2019 Mar;18(1):67-76. doi: 10.1016/j.jcm.2018.11.001. Epub 2019 May 7. French.

Reference Type BACKGROUND
PMID: 31193199 (View on PubMed)

Lonstein JS. Regulation of anxiety during the postpartum period. Front Neuroendocrinol. 2007 Aug-Sep;28(2-3):115-41. doi: 10.1016/j.yfrne.2007.05.002. Epub 2007 Jun 2.

Reference Type BACKGROUND
PMID: 17604088 (View on PubMed)

Lee SB, Shin HS. [Effects of Kangaroo Care on anxiety, maternal role confidence, and maternal infant attachment of mothers who delivered preterm infants]. Taehan Kanho Hakhoe Chi. 2007 Oct;37(6):949-56. doi: 10.4040/jkan.2007.37.6.949. Korean.

Reference Type BACKGROUND
PMID: 17992067 (View on PubMed)

Fujita M, Endoh Y, Saimon N, Yamaguchi S. Effect of massaging babies on mothers: pilot study on the changes in mood states and salivary cortisol level. Complement Ther Clin Pract. 2006 Aug;12(3):181-5. doi: 10.1016/j.ctcp.2006.01.003. Epub 2006 Mar 13.

Reference Type BACKGROUND
PMID: 16835028 (View on PubMed)

Feijo L, Hernandez-Reif M, Field T, Burns W, Valley-Gray S, Simco E. Mothers' depressed mood and anxiety levels are reduced after massaging their preterm infants. Infant Behav Dev. 2006 Jul;29(3):476-80. doi: 10.1016/j.infbeh.2006.02.003. Epub 2006 Mar 27.

Reference Type BACKGROUND
PMID: 17138300 (View on PubMed)

Erduran B, Yaman Sozbir S. Effects of intermittent kangaroo care on maternal attachment, postpartum depression of mothers with preterm infants. J Reprod Infant Psychol. 2023 Nov;41(5):556-565. doi: 10.1080/02646838.2022.2035703. Epub 2022 Feb 7.

Reference Type BACKGROUND
PMID: 35129000 (View on PubMed)

Badiee Z, Faramarzi S, MiriZadeh T. The effect of kangaroo mother care on mental health of mothers with low birth weight infants. Adv Biomed Res. 2014 Oct 20;3:214. doi: 10.4103/2277-9175.143262. eCollection 2014.

Reference Type BACKGROUND
PMID: 25371871 (View on PubMed)

Anwar F, Warsi A, Ahmed J, Zaidi B, Turab A, Khan MA, Khan KS. The effectiveness of kangaroo mother care in lowering postpartum depression in mothers of preterm and low birth weight babies: a systematic review and meta-analysis. Ann Med Surg (Lond). 2023 Apr 12;85(6):2841-2848. doi: 10.1097/MS9.0000000000000480. eCollection 2023 Jun.

Reference Type BACKGROUND
PMID: 37941566 (View on PubMed)

Parsa P, Karimi S, Basiri B, Roshanaei G. The effect of kangaroo mother care on physiological parameters of premature infants in Hamadan City, Iran. Pan Afr Med J. 2018 May 31;30:89. doi: 10.11604/pamj.2018.30.89.14428. eCollection 2018.

Reference Type BACKGROUND
PMID: 30344873 (View on PubMed)

Johnson JD, Cocker K, Chang E. Infantile Colic: Recognition and Treatment. Am Fam Physician. 2015 Oct 1;92(7):577-82.

Reference Type BACKGROUND
PMID: 26447441 (View on PubMed)

Daelemans S, Peeters L, Hauser B, Vandenplas Y. Recent advances in understanding and managing infantile colic. F1000Res. 2018 Sep 7;7:F1000 Faculty Rev-1426. doi: 10.12688/f1000research.14940.1. eCollection 2018.

Reference Type BACKGROUND
PMID: 30271572 (View on PubMed)

WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.

Reference Type BACKGROUND
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Zeevenhooven J, Koppen IJ, Benninga MA. The New Rome IV Criteria for Functional Gastrointestinal Disorders in Infants and Toddlers. Pediatr Gastroenterol Hepatol Nutr. 2017 Mar;20(1):1-13. doi: 10.5223/pghn.2017.20.1.1. Epub 2017 Mar 27.

Reference Type BACKGROUND
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Wolke D, Bilgin A, Samara M. Systematic Review and Meta-Analysis: Fussing and Crying Durations and Prevalence of Colic in Infants. J Pediatr. 2017 Jun;185:55-61.e4. doi: 10.1016/j.jpeds.2017.02.020. Epub 2017 Apr 3.

Reference Type BACKGROUND
PMID: 28385295 (View on PubMed)

Sheidaei A, Abadi A, Zayeri F, Nahidi F, Gazerani N, Mansouri A. The effectiveness of massage therapy in the treatment of infantile colic symptoms: A randomized controlled trial. Med J Islam Repub Iran. 2016 Apr 9;30:351. eCollection 2016.

Reference Type BACKGROUND
PMID: 27453882 (View on PubMed)

Tekgunduz KS, Gurol A, Apay SE, Caner I. Effect of abdomen massage for prevention of feeding intolerance in preterm infants. Ital J Pediatr. 2014 Nov 14;40:89. doi: 10.1186/s13052-014-0089-z.

Reference Type BACKGROUND
PMID: 25394549 (View on PubMed)

Mansouri S, Kazemi I, Baghestani AR, Zayeri F, Nahidi F, Gazerani N. A placebo-controlled clinical trial to evaluate the effectiveness of massaging on infantile colic using a random-effects joint model. Pediatric Health Med Ther. 2018 Nov 16;9:157-163. doi: 10.2147/PHMT.S185214. eCollection 2018.

Reference Type BACKGROUND
PMID: 30532613 (View on PubMed)

Cetinkaya B, Basbakkal Z. The effectiveness of aromatherapy massage using lavender oil as a treatment for infantile colic. Int J Nurs Pract. 2012 Apr;18(2):164-9. doi: 10.1111/j.1440-172X.2012.02015.x.

Reference Type BACKGROUND
PMID: 22435980 (View on PubMed)

Ertem GS, Ozyazicioglu N. Effects of colic massage and kangaroo care on infantile colic pain, crying and sleep duration: A randomized controlled trial. J Pediatr Nurs. 2025 Sep-Oct;84:390-396. doi: 10.1016/j.pedn.2025.07.003. Epub 2025 Jul 10.

Reference Type DERIVED
PMID: 40644765 (View on PubMed)

Study Documents

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Document Type: article

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Document Type: rewiev

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Document Type: Guide

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Document Type: article

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Document Type: doctora thesis

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Related Links

Access external resources that provide additional context or updates about the study.

https://doi.org/10.26911/thejmch.2024.09.01.05

Meta-analysis the effect of baby massage in increasing quality of sleep and infant body weight.

https://doi.org/10.4236/ojped.2022.121019

Kangaroo Mother Care and Neonatal Outcomes in the Pediatric Department of CHU Gabriel Toure

https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp

Akdoğan R. The Effect of Spa and Massage Applied to Babies on Colic Symptoms: A Randomized Controlled Trial. PhD Thesis. Istanbul University. Istanbul. 2023

https://doi.org/10.26911/thejmch.2022.07.01.07

Meta-analysis the effect of baby massage in increasing quality of sleep and infant body weight

https://doi.org/10.1016/j.earlhumdev.2005.11.008

A controlled trial of skin-to-skin contact in extremely preterm infants.

https://scholar.google.com.tr/scholar?q=Efficacy+of+abdominal+massage+on+feeding+intolerance+of+preterm+neonates.&hl=tr&as_sdt=0&as_vis=1&oi=scholart

Efficacy of abdominal massage on feeding intolerance of preterm neonetes

https://doi.org/10.4103/nms.nms_80_17

The effects of infant massage on maternal postpartum depression: A randomized controlled trial.

http://dx.doi.org/10.4236/psych.2015.616204

The effects of infant massage on maternal distress: a systematic review

https://doi.org/10.22038/ijp.2020.50006.3990

Comparing the effect of kangaroo mother care and massage on preterm infant pain score, stress, anxiety, depression, and stress coping strategies of their mothers.

https://doi.org/10.1016/j.infbeh.2017.08.006

Infant massage improves attitudes toward childbearing, maternal satisfaction and pleasure in parenting

Other Identifiers

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E-25691463-900-35292

Identifier Type: -

Identifier Source: org_study_id