Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates

NCT04287322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-03-02

No results posted yet for this study

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.

Conditions

  • Prematurity

Interventions

BEHAVIORAL

Tactile-kinesthetic stimulation

Tactile-kinesthetic stimulation involved three sessions per day; morning, afternoon, and evening for 10 days starting day 3 of life (initial contact). The stimulation included three phases; Phase 1: With neonates in prone position, moderate pressure was used to provide 12 strokes with palms of the hands, each stroke lasting 5 seconds. The strokes were provided in each area as follows: head, neck, shoulders and back. Phase 2: In supine position, twelve moderate pressure strokes with palms of the hands, 5 seconds each, were provided in each area as follows:forehead,cheeks,chest, abdomen, upper limbs (each separately), lower limbs, palms and soles. Phase 3: Kinesthetic stimulation was done for 5 minutes. The intervention comprised five passive flexion and extension movements of each large joint.

BEHAVIORAL

Recorded maternal voice

Following informed written consent from mothers,maternal voice was recorded (5 minutes talking to her baby and 10 minutes singing) using Philips Electronics, SA2RGA04KS, Netherlands. Recorded voice was played back inside the incubator or cot via micro audio system, which has been validated for safety and feasibility in previous studies (Doheny et al., 2012. Preterm neonate lay in supine/lateral position and recorded maternal voice was played for 15 minutes three times a day (morning, afternoon, evening) starting on day 3 of life up to day 12 of life (10 days).

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER
  • Moi University

    lead OTHER

Principal Investigators

  • Fabian Esamai, PhD · Moi University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
3 Days
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-14
Primary Completion
2018-10-17
Completion
2019-01-28

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04287322 on ClinicalTrials.gov