Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates

NCT04287322 | Completed

• 1 other identifier: MOiU
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Keywords

Maternal voice and tactile-kinesthetic stimulation

Outcome Measures

Primary Outcomes (6)

• Oxygen saturation

  The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and oxygen saturation readings were recorded by research assistant.

  15 minutes

• Heart rate

  The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and heart rate readings were recorded by research assistants.

  15 minutes

• Respiratory rate was measured by counting breaths per minute by the research assistants.

  Recording respiratory rate

  15 minutes

• Body temperature

  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.

  15 minutes

• Weight

  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.

  21 days

• Behavioral development

  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.

  21 days

Study Arms (3)

Tactile-kinesthetic stimulation

EXPERIMENTAL

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

Behavioral: Tactile-kinesthetic stimulation

Recorded maternal voice

EXPERIMENTAL

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).

Behavioral: Recorded maternal voice

Control

NO INTERVENTION

Received only standard nursery care

Interventions

Tactile-kinesthetic stimulation BEHAVIORAL

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.

Tactile-kinesthetic stimulation

Recorded maternal voice BEHAVIORAL

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).

Recorded maternal voice

Eligibility Criteria

• Age: 3 Days - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Moi University: lead
• Alexandria University: collaborator

Study Sites (1)

Constantine Akwanalo

Eldoret, Kenya

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Fabian Esamai, PhD

  Moi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants were blinded of aim of study, group allocations and interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical consultant

Model Details: Quasi-experimental design

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 27, 2020
• Study Start: January 14, 2018
• Primary Completion: October 17, 2018
• Study Completion: January 28, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)