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

NCT06727760 | Completed DMC

• 1 other identifier: E-25691463-900-35292
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• infantile scale scores

  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

  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

  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 Outcomes (2)

• maternal function scores.

  up to 3 weeks

• colic babies crying and sleeping time

  up to 3 weeks

Study Arms (3)

massage group

EXPERIMENTAL

Colic massage is applied to babies with infantile colic

Behavioral: massage

kangaroo care group

EXPERIMENTAL

Kangaroo care is applied to babies with infantile colic

Behavioral: kangroo care

control group

NO INTERVENTION

No intervention is applied to babies with infantile colic

Interventions

massage 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.

massage group

kangroo care 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.

kangaroo care group

Eligibility Criteria

• Age: 3 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with infantile colic
• Being born at term

You may not qualify if:

• Lactose allergy,
• Diagnosed with another chronic disease
• Skin problem,
• Weighing less than 2500 grams
• Having congenital anomalies
• Vomiting, constipation and malnutrition
• being a volunteer
• being literate and
• having a smart phone.
• using incorrect massage and kangaroo care
• using other traditional and medical treatments during the study.

Sponsors & Collaborators

• Gulsah Sunay Ertem: lead

Study Sites (1)

Ataturk City Hospital

Balıkesir, Altıeylül, 10020, Turkey (Türkiye)

Location

Related Publications (21)

• 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.

  PMID: 18086500 BACKGROUND

• 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.

  PMID: 11246096 BACKGROUND

• 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.

  PMID: 31193199 BACKGROUND

• 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.

  PMID: 17604088 BACKGROUND

• 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.

  PMID: 17992067 BACKGROUND

• 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.

  PMID: 16835028 BACKGROUND

• 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.

  PMID: 17138300 BACKGROUND

• 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.

  PMID: 35129000 BACKGROUND

• 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.

  PMID: 25371871 BACKGROUND

• 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.

  PMID: 37941566 BACKGROUND

• 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.

  PMID: 30344873 BACKGROUND

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

  PMID: 26447441 BACKGROUND

• 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.

  PMID: 30271572 BACKGROUND

• 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.

  PMID: 13214956 BACKGROUND

• 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.

  PMID: 28401050 BACKGROUND

• 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.

  PMID: 28385295 BACKGROUND

• 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.

  PMID: 27453882 BACKGROUND

• 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.

  PMID: 25394549 BACKGROUND

• 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.

  PMID: 30532613 BACKGROUND

• 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.

  PMID: 22435980 BACKGROUND

• 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.

  PMID: 40644765 DERIVED

Related Links

• Meta-analysis the effect of baby massage in increasing quality of sleep and infant body weight.
• The Effects of Kangaroo Mother Care (KMC) on the Fuss and Crying Time of Colicky Infants. Iranian Journal of Neonatology, 6(1).
• Effects of abdominal massage on feeding tolerance in preterm infants hospitalized in selected hospitals of Isfahan-Iran.
• Kangaroo Mother Care and Neonatal Outcomes in the Pediatric Department of CHU Gabriel Toure
• Akdoğan R. The Effect of Spa and Massage Applied to Babies on Colic Symptoms: A Randomized Controlled Trial. PhD Thesis. Istanbul University. Istanbul. 2023
• Meta-analysis the effect of baby massage in increasing quality of sleep and infant body weight
• A controlled trial of skin-to-skin contact in extremely preterm infants.
• Efficacy of abdominal massage on feeding intolerance of preterm neonetes
• The effects of infant massage on maternal postpartum depression: A randomized controlled trial.
• The effects of infant massage on maternal distress: a systematic review
• Comparing the effect of kangaroo mother care and massage on preterm infant pain score, stress, anxiety, depression, and stress coping strategies of their mothers.
• The impact of baby massage training on awareness, perceived stress and breastfeeding self-efficacy of mothers with hospitalized neonate
• Infant massage improves attitudes toward childbearing, maternal satisfaction and pleasure in parenting

MeSH Terms

Conditions

Colic; Depression, Postpartum; Crying

Interventions

Massage

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• nurcan özyazıcıoğlu, professor

  bursa uludağ üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: December 11, 2024
• Study Start: March 8, 2022
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)