Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

University of Indonesia (UI)

Status: Completed

Conditions: Infant, Premature, Diseases

Treatments: Other: Placebo; Procedure: Tactile-kinesthetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04807088

681/UN2.F1/ETIK/2015

Details and patient eligibility

About

An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital.

Full description

Preterm neonates were recruited via random sampling and divided into two groups (intervention group and control group). A written informed consent was obtained from the parents or guardians.

Before the intervention, physical examination was performed to ensure the neonates had normal vital signs, were healthy and did not present with congenital abnormalities.

In the intervention group, TKS was performed with specific baby oil for 15 minutes, three times a day, for 10 days. After 10 days, TKS was applied once daily by the mother or caregiver. TKS implementation at home was supervised by the investigator or nurse through phone call. The TKS were documented by the mother or caregiver in the diary card, which should be brought during the next visit when the neonate was 11-14 days old. In addition to TKS, history of illness and nutrition which was confirmed through history taking during hospital or home visit, was also recorded. The participants who did not go the hospital were home visited by the investigator or nurse.

Anthropometric measurement by investigator and trained nurses and Dubowitz examination was performed by investigator in a warm and quiet place in the neonatal unit, mother-baby unit, outpatient clinic or participants' home while the neonate was fully alert.

At 3 months of age, infant development was assessed by the investigator using the Capute scales (Developmental Quotient of Clinical Adaptive Test [DQ CAT], Clinical Linguistic Adaptive Milestone Scale [DQ CLAMS]) and the Full Scale Developmental Quotient (FS DQ) score. The Clinical Linguistic Adaptive Milestone Scale (CLAMS) score was based on the parent's report of language skill attainment. The Clinical Adaptive Test (CAT) score was based on the child's performance according to the listed items.

Enrollment: 126 patients

Sex: All

Ages: 6 to 24 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 6-24-hour-old preterm infants with 32-<37 gestational weeks
• birth weight ranging from 1,500 to <2,500 g
• appropriate for gestational age
• a minimum Apgar score of seven at the fifth minute
• no history of neonatal resuscitation
• stable vital condition
• no invasive therapy during hospitalisation

Exclusion criteria

• intrauterine growth retardation
• untreated clinical sepsis
• congenital abnormalities such as congenital heart disease
• history of hyperbilirubinemia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

Tactile-kinesthetic stimulation (TKS) was performed with a specific baby oil provided by the investigator. Tactile stimulation was performed while the neonate was in prone position. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Every massage was performed for 2 × 5 seconds, with a total duration of 5 minutes. Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 2 × 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 10 consecutive days.

Treatment:

Procedure: Tactile-kinesthetic Stimulation

Control Group

Placebo Comparator group

Description:

Control group was not given TKS.

Treatment:

Other: Placebo