Tactile/kinesthetic Stimulus Program

Gonca Karatas Baran

Status: Enrolling

Conditions: Enteral Feeding; Hospital Stay; Breast Feeding, Exclusive

Treatments: Other: Tactile/kinesthetic Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05486663

NEONATAL CARE

Details and patient eligibility

About

The study will be carried out as a prospective randomized controlled clinical study to determine the effect of tactile/kinesthetic stimulus program on preterm infants on transition time to full sucking, sucking success and hospital stay.

Full description

Application of the Research Tactile/kinesthetic Group After the stability in the general health status of the babies and the oral feeding decision are made, for 14 days, 2 times a day, just before feeding; There will be a 15-minute tactile/kinesthetic application. Complications that may develop during the tactile/kinesthetic application in infants will be monitored by evaluating the physical findings of the preterm infant and on the bedside monitor. In cases such as decreased oxygen saturation, apnea and bradycardia during the tactile/kinesthetic intervention, the procedure will not be performed or will be delayed until the baby regains stability.

Note: The application will be carried out by showing the necessary sensitivity for the preterm baby (not shaking the baby, not moving the baby suddenly, the temperature of the hands being close to the baby's body temperature, etc.) and by the researcher nurses experienced in NICU.

Control Group Tactile/kinesthetic applications will not be applied to the control group and these babies will be followed up for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made.

In both groups; Baby scales and tape measure will be used for anthropometric measurement of body weight before and after breastfeeding. Other data will be obtained from the patient file and observations made during the hospitalization of the preterm infant.

The LATCH Breastfeeding Diagnosis Form (during the first mother's breastfeeding) will be filled in by observation, by the researcher and an observer nurse, as it is an observation-based form. The researcher will train the observer on the use of the LATCH Breastfeeding Diagnostic Form. The researcher and observer will simultaneously and independently evaluate each preterm infant by scoring the LATCH Breastfeeding Diagnostic Form during the breastfeeding period. In order to evaluate the agreement among the observers, the agreement will be evaluated by looking at Cohen's Kappa coefficient. The LATCH second measurement will be made on Day 5.

The amount of food taken during breastfeeding within 14 days (1st, 5th, 9th, 13th, and on the day of discharge) will be determined by measuring body weight before and after feeding. Body weight will be weighed before and after feeding at discharge. The times of full enteral feeding and full oral feeding will be recorded in the groups.

Hypotheses H0 hypothesis: Tactile/kinesthetic stimulus interventions have no effect on transition time to full oral feeding in preterm infants.

Hypothesis H1: In preterm infants, interventions with tactile/kinesthetic stimuli have an effect on transition time to full oral feeding.

Enrollment: 80 estimated patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Born between 28-32 weeks of gestation,
• Stable vital signs,
• 1st and 5th minute APGAR score between 6-10,
• Babies who have received mechanical ventilator or continuous positive air pressure (CPAP) or both support after 48 hours have passed after stabilization,
• Does not have an anomaly that will prevent feeding,
• Oral feeding decision has been made,
• Babies of mothers who are willing to breastfeed their babies,
• Babies of parents who volunteered to participate in the study will be taken.

Exclusion criteria

• IUGG,
• Infants with severe asphyxia,
• Babies born with low birth weight according to their gestational week,
• Having an anomaly that will prevent her from feeding,
• Babies with unstable vital signs,
• Babies with congenital anomalies or serious complications
• Infants with intraventricular bleeding.

Dismissal Criteria

• Babies whose oral feeding process is interrupted for more than 1 day due to neonatal problems.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Tactile/kinesthetic Group

Experimental group

Description:

After the stability of the general health status of the babies is ensured and the oral feeding decision is made, tactile / kinesthetic application will be made for 14 days, 2 times a day, for 15 minutes just before feeding.

Treatment:

Other: Tactile/kinesthetic Group

Control Group

No Intervention group

Description:

Tactile / kinesthetic applications will not be applied to the control group and these babies will be followed for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made.