An interventional study of Kangaroo Care and Kangaroo Care+lullabies in The Gestational Age of the Newborn is Between 28-37 Weeks, Stable Health Status of the Newborn and Mothers' Willingness to Participate in the Study, sponsored by Kirsehir Ahi Evran Universitesi. Not yet recruiting. Open to participants aged 28 Weeks to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Kirsehir Ahi Evran Universitesi · Not applicable, Interventional, and Supportive care
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.
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.
Kirsehir Ahi Evran Universitesi is the lead sponsor of 133 studies on the registry; 55 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria (during the research):
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
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
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.
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.
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.
Time frame: First measurement - Before starting the study
2. Mother Infant Physiologic Parameters Monitoring Form
The 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.
Time frame: Before and after the intervention for 3 days after starting the study
Spielberg State Anxiety Scale
The 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.
Time frame: Before starting the study and after completion of the study at the end of 3 days
No study locations are listed for this record.
Plan to share: Undecided — Individual participant data (IPD) will be shared upon reasonable request from qualified researchers. Requests will be evaluated by the study investigators, and data will be shared in compliance with ethical and institutional regulations.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Kirsehir Ahi Evran Universitesi