Clinical trial NCT06953817: The Effect of Kangaroo Care Education on Mother-Infant Bonding, Maternal and Neonatal Comfort
Official title: The Effect of Kangaroo Care Education Given to Pregnant Women in the Third Trimester on Mother-Infant Bonding, Maternal and Neonatal Comfort: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kangaroo Care
Pregnant
Bonding
Comfort
Keywords: Kangaroo care
Neonatal
Mother-Infant Bonding
Neonatal Comfort
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled and quasi-experimental research
Primary purpose: SUPPORTIVE_CARE

Brief summary: Kangaroo care encompasses early and continuous skin-to-skin contact, frequent and regular breastfeeding, early discharge from the hospital, and other supportive care practices necessary for the infant . Through kangaroo care, the transition of newborns from intrauterine to extrauterine life is facilitated, and a strong and secure bond between the mother and the newborn is established. Kangaroo care, which does not require any additional equipment or special preparation, is a safe method that can be easily and frequently implemented due to its numerous benefits. Since maternal and neonatal health affects not only the family but also public health, maternal and neonatal comfort is considered to be of great importance. Kangaroo care is believed to contribute positively to the enhancement of this comfort and the strengthening of the mother-infant bond. Despite the well-documented benefits of kangaroo care in the literature, its implementation in our country has not reached the desired level. This study is planned to determine the effect of kangaroo care education provided to pregnant women in the third trimester on mother-infant bonding and maternal and neonatal comfort.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for Pregnant Women:

* Aged 18 years or older,
* Primiparous (first pregnancy),
* Between 35-38 weeks of gestation,
* Able to speak Turkish and/or without communication barriers,
* At least a primary school graduate,
* A healthy pregnancy,
* Good health status during and after delivery,
* No contraindications for providing kangaroo care,
* No physical and/or mental health issues,
* No infectious diseases transmitted through contact,
* Willing to participate in the study,
* Use of WhatsApp application,
* Pregnant women expecting a single baby will be included in the study.

Inclusion Criteria for the Infant:

* Full-term,
* No need for oxygen support,
* No congenital anomalies,
* No infectious diseases,
* Stable general condition.

Exclusion Criteria:

* Exclusion Criteria for Pregnant Women:
* Multiparity,
* Foreign nationals, migrants, or those with communication difficulties,
* High-risk pregnancies,
* Physical and/or mental health issues,
* Presence of an infectious disease transmitted through contact,
* Refusal to participate in the study,
* Non-users of phone and/or WhatsApp application,
* Pregnant women expecting multiple babies will be excluded from the study.

Exclusion Criteria during Data Collection:

* Women who no longer wish to continue in the study after volunteering,
* Women who cannot be reached via WhatsApp and/or phone,
* Women whose infants experience death (exitus),
* Women whose infants have conditions preventing the application of kangaroo care will be excluded from the study.

Primary outcomes:
measure: Evaluation of Mother-Infant Bonding in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
timeFrame: At the time of first participation in the study in the third trimester, within the first 24 hours after delivery, and 4 weeks after delivery
measure: Evaluation of Maternal Comfort in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
timeFrame: At the time of first participation in the study in the third trimester, within the first 24 hours after delivery, and 4 weeks after delivery
measure: Evaluation of Neonatal Comfort in Pregnant Women Who Received Kangaroo Care Education in the Third Trimester
timeFrame: Newborn comfort behaviors will be evaluated within the first 24 hours after birth and again at 4 weeks postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Yalova University
Study officials:
affiliation: Yalova Unıversıty
name: EMEL AVÇİN, Doctor
role: PRINCIPAL_INVESTIGATOR
References: