The Effect of Kangaroo Care and Lullaby on Mother-Baby Physiological Parameters and Mother's State Anxiety Level

NCT06964204 | Not Yet Recruiting

• 1 other identifier: SU-2025-041
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was planned to investigate the effect of kangaroo care and lullaby on mother-baby physiologic parameters and mother's state anxiety level in premature newborns.

Conditions

The Gestational Age of the Newborn is Between 28-37 Weeks; Stable Health Status of the Newborn; Mothers' Willingness to Participate in the Study

Keywords

Infant, Premature; Kangaroo-Mother Care Method; Lullabies; Physiological Parameters; Anxiety

Outcome Measures

Primary Outcomes (1)

• 1. Mother and Newborn Introductory Information Form

  The form prepared by the researcher in line with the literature (Arnon et al., 2014) consists of a total of 22 questions about the mother and the infant. The questions questioning the characteristics of the mother in the form are "age, educational status, occupation, family type, presence of social security, economic status, disease status, number of pregnancies, whether the last pregnancy was planned, and when she breastfed her baby for the first time after birth". The questions about the infant consisted of "gender, gestational age, postnatal age, mode of delivery, 1st and 5th minute APGAR score, birth and weight, height, head circumference, hospitalization diagnosis and duration, and infant's diet". The form was sent to 5 academicians specialized in Pediatric Nursing and their expert opinions were obtained, and the information form was finalized in line with their suggestions.

  First measurement - Before starting the study

Secondary Outcomes (1)

• 2. Mother Infant Physiologic Parameters Monitoring Form

  Before and after the intervention for 3 days after starting the study

Other Outcomes (1)

• Spielberg State Anxiety Scale

  Before starting the study and after completion of the study at the end of 3 days

Study Arms (2)

Kangaroo Care

EXPERIMENTAL

Kangaroo care will be applied to the babies in the 1st group and inclusion in the groups will be done by randomization.

Behavioral: Kangaroo Care

Kangaroo Care + Lullaby

EXPERIMENTAL

In addition to kangaroo care, mothers will sing a lullaby to the babies in the 2nd group and inclusion in the groups will be done by randomization.

Behavioral: Kangaroo Care+lullabies

Interventions

Kangaroo Care BEHAVIORAL

Kangaroo care practice will be carried out in 3 stages: "preparation, implementation and recording stage". Vital signs of the baby such as body temperature, heart rate, respiratory rate will be evaluated and necessary materials such as hats and covers will be prepared. In the implementation phase; the general condition of the baby will be checked, clothing and position will be adjusted, and then the baby will be transferred to the mother. After the baby is placed, his/her back will be covered with a blanket and the mother will be asked to support the baby's back with one hand and the hips with the other. When 60 minutes are completed, kangaroo care will be terminated. After the baby is placed, vital signs and general condition will be evaluated and all nursing observations will be recorded. For the babies in the other group, their mothers will sing lullabies along with kangaroo care and inclusion in the groups will be done by randomization.

Kangaroo Care

Kangaroo Care+lullabies BEHAVIORAL

For the babies in the other group, their mothers will sing lullabies along with kangaroo care and inclusion in the groups will be done by randomization.

Kangaroo Care + Lullaby

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The gestational age of the newborn is between 28-37 weeks,
• Stable health status of the newborn,
• Mothers' willingness to participate in the study.

You may not qualify if:

• The gestational week of the newborn is below 28 weeks and above 37 weeks
• Unstable health status of the newborn,
• Hospitalization for at least 3 days,
• Parents were not willing to participate in the study.
• Sudden need for resuscitation
• Sudden deterioration of the stabilization of health status

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Related Publications (4)

• Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.

  PMID: 31397094 RESULT

• Öner N, Le Compte A. Durumluk Sürekli Kaygı Envanteri El Kitabı, İstanbul, Boğaziçi Üniversitesi Yayınları, İstanbul, 1983.

  RESULT

• Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.

  PMID: 36511921 RESULT

• Arnon S, Diamant C, Bauer S, Regev R, Sirota G, Litmanovitz I. Maternal singing during kangaroo care led to autonomic stability in preterm infants and reduced maternal anxiety. Acta Paediatr. 2014 Oct;103(10):1039-44. doi: 10.1111/apa.12744. Epub 2014 Aug 11.

  PMID: 25039678 RESULT

MeSH Terms

Conditions

Premature Birth; Anxiety Disorders

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Edanur Tar Bolacali, PhD

CONTACT

+908504412483; edanurtar.1107@gmail.com

Sibel Kucukoglu, Kucukoglu, PhD

CONTACT

+903322231623; s_nadaroglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: The sample of the study will be selected by "random sampling" method from mothers and their babies who are diagnosed and treated in the NICU of Osmaniye State Hospital and who meet the criteria for acceptance into the study. The sample size of the study was calculated as a total of 57 newborns in the G\*Power 3.1.9.2. program with reference to a similar study in the literature (Arnon, 2014), which is parallel to our study. In the study, in order to reduce selection bias and control variables that may have an effect on the outcome parameters, the groups will be named as A and B and newborns will be randomly assigned to these groups. A: kangaroo care and B: kangaroo care+nurture or B: kangaroo care and A: kangaroo care+nurture will be determined by lottery. Before the study, mothers will be informed about both groups during the informed consent process and it will not be specified which group the newborns will be in.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: May 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05