Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates
Primary Purpose
Prematurity
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Tactile-kinesthetic stimulation
Recorded maternal voice
Sponsored by

About this trial
This is an interventional supportive care trial for Prematurity focused on measuring Maternal voice and tactile-kinesthetic stimulation
Eligibility Criteria
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.
Sites / Locations
- Constantine Akwanalo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Tactile-kinesthetic stimulation
Recorded maternal voice
Control
Arm Description
Received tactile-kinesthetic stimulation three times a day (morning, afternoon and evening) for 10 days starting on day 3 of life (initial contact).
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).
Received only standard nursery care
Outcomes
Primary Outcome Measures
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.
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.
Respiratory rate was measured by counting breaths per minute by the research assistants.
Recording respiratory rate
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04287322
First Posted
February 18, 2020
Last Updated
February 27, 2020
Sponsor
Moi University
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04287322
Brief Title
Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates
Official Title
Effect of Auditory and Tactile-kinesthetic Stimulation on Physiological Parameters, Physical Growth and Behaviour of Preterm Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
October 17, 2018 (Actual)
Study Completion Date
January 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Moi University
Collaborators
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Maternal voice and tactile-kinesthetic stimulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Quasi-experimental design
Masking
Outcomes Assessor
Masking Description
The research assistants were blinded of aim of study, group allocations and interventions.
Allocation
Non-Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tactile-kinesthetic stimulation
Arm Type
Experimental
Arm Description
Received tactile-kinesthetic stimulation three times a day (morning, afternoon and evening) for 10 days starting on day 3 of life (initial contact).
Arm Title
Recorded maternal voice
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Received only standard nursery care
Intervention Type
Behavioral
Intervention Name(s)
Tactile-kinesthetic stimulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recorded maternal voice
Intervention Description
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).
Primary Outcome Measure Information:
Title
Oxygen saturation
Description
The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and oxygen saturation readings were recorded by research assistant.
Time Frame
15 minutes
Title
Heart rate
Description
The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and heart rate readings were recorded by research assistants.
Time Frame
15 minutes
Title
Respiratory rate was measured by counting breaths per minute by the research assistants.
Description
Recording respiratory rate
Time Frame
15 minutes
Title
Body temperature
Description
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.
Time Frame
15 minutes
Title
Weight
Description
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.
Time Frame
21 days
Title
Behavioral development
Description
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.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabian Esamai, PhD
Organizational Affiliation
Moi University
Official's Role
Study Chair
Facility Information:
Facility Name
Constantine Akwanalo
City
Eldoret
Country
Kenya
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates
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