Effect of Auditory and Tactile-kinesthetic Stimulation on Physiological Parameters, Physical Growth and Behaviour of Preterm Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Moi University
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
The research assistants were blinded of aim of study, group allocations and interventions.
Eligibility Criteria
- Ages
- 3 Days to 3 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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).
Intervention: Tactile-kinesthetic stimulation (Behavioral)
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).
Intervention: Recorded maternal voice (Behavioral)
Control
Received only standard nursery care
Outcomes
Primary Outcomes
Weight
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 15 minutes
Recording respiratory rate
Body temperature
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
CONSTANTINE OLIEBA AKWANALO
Clinical consultant
Moi University