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

NCT ID: NCT06964204

Last Updated: 2025-05-09

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-09-15

Brief Summary

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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.

Detailed Description

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Due to health problems, premature infants are subjected to many painful and uncomfortable interventions such as intubation and respiratory support, umbilical catheter, intravenous interventions, nasogastric catheter, sometimes gastrostomy, peritoneal dialysis, eye examinations and operations. The premature newborn may therefore be deprived of compassionate care that will provide comfort, such as sucking, cuddling, touching and eye contact, which are basic needs. The mother-infant relationship may be negatively affected because premature babies are different from what is imagined and have some health problems and are transferred to the intensive care unit. The birth of a premature baby, which is a crisis for the whole family, can cause intense anxiety and fear that the mother will lose her baby. The mother may avoid touching her baby for fear of harming her baby, and participating in the care of her baby can be very difficult and anxiety-provoking. Nurses working in the neonatal service and neonatal intensive care unit play a major role in ensuring mother-infant interaction in premature babies. It should enable the mother to share the same room (rooming-in), skin-to-skin contact (kangaroo care), eye-to-eye contact, hugging her baby, participating in the care of her baby and maintaining breastfeeding, which will increase the intimacy between mother and baby. Kangaroo care is a method in which newborns are placed on their mothers' chests, facing the mother, and skin-to-skin contact between mother and baby is ensured in order to ensure the early discharge of the baby from the hospital and to ensure that the baby starts to benefit from breast milk as soon as possible. Kangaroo care should be initiated as early as possible in the delivery room or neonatal intensive care unit to ensure thermal regulation, physiological stability, appropriate stimulation and to increase the rate of attachment and breastfeeding. It is known that the fetus recognizes the mother's voice from the 32nd week of gestation and in the postnatal period and responds with parameters such as increased pulse rate. It is argued that lullaby recital in neonatal intensive care has a relaxing effect on the newborn by masking environmental stressors and negative sounds. During kangaroo care, the baby's ear rests directly against the mother's breast, skin-to-skin contact and sounds are transferred to the baby through tissue and air, and the mother's voice is compared to the fetal auditory environment that the baby hears in the uterus, and it is thought that the positive effects on the mother and baby should be examined. This study was planned to examine the effect of kangaroo care and lullaby on the physiologic parameters of the mother and infant and the mother's state anxiety level in premature newborns. Thus, it is aimed to provide physiological stability in the infant and to increase mother-infant bonding by determining the effect of kangaroo care and lullaby, which are safe, inexpensive and easily applicable methods, on the vital signs of the mother and infant and the anxiety level of the mother.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Kangaroo Care

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

Group Type EXPERIMENTAL

Kangaroo Care

Intervention Type 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 + Lullaby

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.

Group Type EXPERIMENTAL

Kangaroo Care+lullabies

Intervention Type 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.

Interventions

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Kangaroo Care

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.

Intervention Type BEHAVIORAL

Kangaroo Care+lullabies

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Edanur Tar Bolacali

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Edanur Tar Bolacali, PhD

Role: CONTACT

+908504412483

Sibel Kucukoglu, Kucukoglu, PhD

Role: CONTACT

+903322231623

References

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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.

Reference Type RESULT
PMID: 31397094 (View on PubMed)

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

Reference Type 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.

Reference Type RESULT
PMID: 36511921 (View on PubMed)

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.

Reference Type RESULT
PMID: 25039678 (View on PubMed)

Other Identifiers

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SU-2025-041

Identifier Type: -

Identifier Source: org_study_id

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