The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory

NCT ID: NCT04506541

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-02-01

Brief Summary

Kangaroo care is a developmental care method determined to improve the quality of life of premature babies. When the benefits of kangaroo care on development and feeding with breast milk on premature babies are considered, term babies should also receive kangaroo care, and kangaroo care should be started immediately after birth. In this research, the authors aimed to investigate the effect of kangaroo care at birth on breast milk only feeding status and infant growth and development according to attachment theory. This is a randomized controlled, experimental, prospective study. The sample of the study consisted of pregnant women between 36-38 gestational weeks, who referred to the pregnant outpatient clinic of Buca Maternity and Children Hospital between March 2017 and February 2019 (n: 132). Pregnant women in the intervention group received "kangaroo care and breastfeeding training," and their babies were given kangaroo care at birth. Routine care was given to the mothers and their babies in the control group. Maternal attachment levels of mothers in both groups after birth and infants' breastfeeding only status and infant growth and development in the first, third, sixth, and ninth months were evaluated.

Detailed Description

The research is a randomized controlled, experimental, prospective study conducted to examine the effect of kangaroo care at birth on feeding with breast milk only and nutritional status and growth-development of the baby according to attachment theory. The research was carried out at the Republic of Turkey, Ministry of Health, Izmir Provincial Health Directorate, Buca Women Birth and Child Diseases Hospital. The population of the study consisted of all pregnant women who were between 36-38 weeks of gestation and referred to the pregnant outpatient clinic between March 2017 and February 2019 (N.8079).Power analysis was carried out to determine the sample group that would represent the population in the research. In the power analysis, the sample was determined by evaluating the reference studies related to the feeding rate of only with breast milk in the first nine months, and the expected growth development level in the first nine months, which were the dependent variables of the research. For the first nine months, the 2.4% value stated in TNSA 2013 regarding feeding with breast milk rate was taken as reference (TNSA, 2013). Studies of Çelik et al. (2014) were taken as reference for the evaluation of growth and development. The number of samples to be taken for each group was determined as a result of the power analysis made according to these values. As a result of the evaluation made with power analysis, the expected effect factor with growth and development was calculated as two-times. Accordingly, it was determined that 48 samples should be taken for each group. Forecasting that data loss may occur in multi-monitoring studies, more than 10% of the sufficient sample size was included in the study (n: 214). The sample of the study consisted of pregnant women who applied to the Ministry of Health, Izmir Provincial Health Directorate, Buca Women Birth and Child Diseases Hospital pregnant outpatient clinic between March 2017 and February 2019, who were between 36-38 weeks of gestation and who met the inclusion criteria (n:132). After determining the sample number of the research, it was decided to make randomization according to the last numbers of the pregnant women's protocol numbers, and to which group the odd and even numbers would be included was determined by the method of a draw. As a result of the draw, the last digit of the protocol number ending with an odd number was included in the control group, the last digit of the protocol number, ending with an even number, was included in the intervention group

Conditions

Breastfeeding, Exclusive; Growth Acceleration; Development, Infant; Attachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Kangaroo Care Group

The pregnant women who were in the kangaroo care group of the study and who were 36-38 weeks of gestation were given 20 minutes of kangaroo care and breastfeeding training by the researcher. A video about "kangaroo care and breastfeeding" was sent to pregnant women to remind them two weeks after the training. Kangaroo care application started in the first minute after giving birth in mothers who were in the kangaroo care group and came to the delivery room. In the first, third, sixth, and ninth months after the discharge of the mothers who started applying kangaroo care, kangaroo care application status, breastfeeding status, baby's growth, and development status were evaluated. In each follow-up, the baby's height, weight, and head circumference were measured with a standard measuring tool.

Group Type: EXPERIMENTAL

Kangaroo Care

Intervention Type: OTHER

Kangaroo care application started in the first minute after giving birth in mothers who were in the kangaroo care group and came to the delivery room.

Control Group

The pregnant women in the control group were not trained other than breastfeeding training given in the hospital. In the maternity room, routine care practices were performed after delivery of the pregnant women. As in mothers in the kangaroo care group, in the first, third, sixth, and ninth months after the discharge of mothers, kangaroo care application situations, breastfeeding conditions, growth, and development of the baby were evaluated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kangaroo Care

Kangaroo care application started in the first minute after giving birth in mothers who were in the kangaroo care group and came to the delivery room.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 36-38 gestational weeks,
• giving birth at 37 weeks or above,
• single and live fetus,
• having no obstacle for applying kangaroo care,
• accepting kangaroo care implementation,
• no need for intervention of newborn,
• no need of newborn to be referred to the neonatal intensive care unit,
• being able to communicate with the pregnant woman,
• having a cesarean section with spinal or epidural anesthesia.

Exclusion Criteria

• being accepted to the delivery room with urgent delivery,
• mothers who did not want to apply kangaroo care,
• mothers who had mental disorders which could harm the baby or self such as postpartum depression,
• the delivery was performed under general anesthesia for pregnant women who had a cesarean delivery.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Buca Women Birth and Child Diseases Hospital

UNKNOWN

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Emine Serap Sarıcan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia GENÇ

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

Ege University

Bornova, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Kangaroo care at birth

Identifier Type: -

Identifier Source: org_study_id