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

The Effect of Kangaroo Care and Lullaby on Mother-Baby Physiological Parameters and Mother's State Anxiety Level in Premature Newborns: A Randomized Controlled Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06964204
Enrollment
57
Registered
2025-05-09
Start date
2025-05-15
Completion date
2025-09-15
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

BEHAVIORALKangaroo 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.

BEHAVIORALKangaroo 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.

Sponsors

Kirsehir Ahi Evran Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
1. Mother and Newborn Introductory Information FormFirst measurement - Before starting the studyThe 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.

Secondary

MeasureTime frameDescription
2. Mother Infant Physiologic Parameters Monitoring FormBefore and after the intervention for 3 days after starting the studyThe chart was created by the researcher to monitor the physiologic parameters of the newborn according to the type of intervention (kangaroo care - lullaby with kangaroo care) (Yasova Barbeau et al., 2019). Measurements of body temperature (°C), peak heart rate (min), respiratory rate (min), oxygen saturation (mmHg), blood pressure (mmHg) of infants and mothers before and after the intervention will be recorded in this chart. The chart was sent to 5 academicians who are experts in Pediatric Nursing and their expert opinions were taken and the chart was finalized by making the necessary changes in line with their suggestions.

Other

MeasureTime frameDescription
Spielberg State Anxiety ScaleBefore starting the study and after completion of the study at the end of 3 daysThe State Anxiety Inventory, which was adapted to Turkish culture by Öner and Le Compte (1983) and norm studies were conducted along with validity and reliability studies, consists of a total of twenty items. The State Anxiety Inventory requires individuals to describe how they feel at a certain moment under certain conditions and to answer the items by taking into account their feelings about the situation they are in. The feelings or behaviors expressed in the items of the State Anxiety Scale are answered by marking one of the options such as (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree to which the individual feels the situation. Scoring: The scales have direct (straight) and inverted expressions. When scoring inverted statements expressing positive emotions, those with a weight value of 1 are converted to 4 and those with a weight value of 4 are converted to 1.

Contacts

Primary ContactEdanur Tar Bolacali, PhD
edanurtar.1107@gmail.com+908504412483
Backup ContactSibel Kucukoglu, Kucukoglu, PhD
s_nadaroglu@hotmail.com+903322231623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026