Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates

Moi University

Status: Completed

Conditions: Prematurity

Treatments: Behavioral: Tactile-kinesthetic stimulation; Behavioral: Recorded maternal voice

Study type: Interventional

Funder types: Other

Identifiers

NCT04287322

MOiU

Details and patient eligibility

About

The study was conducted at a level II special care nursery of the Moi Teaching & Referral Hospital, an academic hospital in the Western region of Kenya. A sample of 108 preterm neonates who met eligibility criteria were studied (36 in auditory group, 36 in tactile-kinesthetic stimulation group, and 36 in control group). Auditory group listened to recorded maternal voice while tactile-kinesthetic group received massage and joint movements.The interventions were provided for 15 minutes, 3 times a day for 10 days while outcome measures were observed for 21 days. The neonates in the control group received standard neonatal care and were observed for outcome measures as those in the intervention groups.

Full description

The study was aimed to determine the effect of auditory stimulation using recorded maternal voice and tactile-kinesthetic stimulation on physiological parameters, physical growth and behavioral development of preterm neonates. Three groups were involved; auditory stimulation, tactile-kinesthetic stimulation and control.

A quasi-experimental design was used to recruit 108 study subjects (36 in each group). A trained researcher conducted the stimulation in the intervention groups and two research assistants did the data entry. The research assistants were blinded to aim of study, group assignments, and interventions received by preterm neonates.

Preterm neonates baseline characteristics and clinical data were obtained at initial contact.

Physiological parameters (heart rate, oxygen saturation and body temperature) were monitored using a cardio-respiratory monitor (CODEC patient monitor CMS6000). Respiratory rate was measured by counting breaths per minute by the research assistant. The parameters were monitored and recorded before, during and after stimulation in the intervention groups. The control group had the measurement recorded in the morning, afternoon and evening.

Physical growth was assessed using weight measurement. Neonates are weighed daily in the nursery and data on weight was entered by research assistants on alternate days.

Neonatal behavioral assessment scale (NBAS) was used to assess behavior at initial contact, day 10, 17 and 24.

Enrollment: 108 patients

Sex: All

Ages: 3 to 3 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• on breast milk or formula feeds
• born 28 to 37 weeks gestational age
• ≥1000grams. The gestation was limited to ≥ 28 weeks and ≥1000grams based on significant neonatal mortality rate in neonates born before 28 weeks gestation and/or weighing <1000grams in MTRH (Njuguna et al., 2015).

Exclusion criteria

• critically ill and those on continuous positive airway pressure (CPAP)
• had neonatal infections including severe sepsis or necrotizing enterocolitis.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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108 participants in 3 patient groups

Tactile-kinesthetic stimulation

Experimental group

Description:

Received tactile-kinesthetic stimulation three times a day (morning, afternoon and evening) for 10 days starting on day 3 of life (initial contact).

Treatment:

Behavioral: Tactile-kinesthetic stimulation

Recorded maternal voice

Experimental group

Description:

Listened to recorded maternal voice stimulation, three times a day (morning, afternoon and evening) for 10 days starting on day 3 of life (initial contact).

Treatment:

Behavioral: Recorded maternal voice

Control

No Intervention group

Description:

Received only standard nursery care