Effect of Auditory & Tactile-kinesthetic Stimulation on Preterm Neonates

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04287322
Study type	Interventional
Source	Moi University
Contact
Status	Completed
Phase	N/A
Start date	January 14, 2018
Completion date	January 28, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms