Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Behavioral: Recorded maternal voice; Behavioral: Tactile-kinesthetic stimulation

• Registration Number: NCT04287322
• Lead Sponsor: Moi University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-14
• Primary Completion: 2018-10-17
• Study Completion: 2019-01-28
• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Recorded maternal voice	Recorded maternal voice	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).
Tactile-kinesthetic stimulation	Tactile-kinesthetic stimulation	Received tactile-kinesthetic stimulation three times a day (morning, afternoon and evening) for 10 days starting on day 3 of life (initial contact).

Primary Outcome Measures

Name	Time	Method
Weight	21 days	Preterm neonates were weighed without clothes on ade digital weighing scale by the research assistants. The scale was disinfected, rechecked and caliberated to zero before each measurement.
Oxygen saturation	15 minutes	The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and oxygen saturation readings were recorded by research assistant.
Heart rate	15 minutes	The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and heart rate readings were recorded by research assistants.
Respiratory rate was measured by counting breaths per minute by the research assistants.	15 minutes	Recording respiratory rate
Body temperature	15 minutes	The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) with a temperature probe and temperature readings were recorded by research assistants.
Behavioral development	21 days	Neonatal Behavioral Assessment Scale by Brazelton TB \& Nugent J., (2011) was administered to each preterm neonate in the study by a trained research assistant. Minimum score was 1 and maximum score 9, a higher score indicated better behavioral development of preterm neonate.

Trial Locations

Locations (1)

Constantine Akwanalo; 🇰🇪 Eldoret, Kenya