Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates

NCT ID: NCT04287322

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-14
• Study Completion Date: 2019-01-28

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.

Conditions

Prematurity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Tactile-kinesthetic stimulation

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Recorded maternal voice

Intervention Type: 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).

Control

Received only standard nursery care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: collaborator

Moi University

OTHER

Sponsor Role: lead

Responsible Party

CONSTANTINE OLIEBA AKWANALO

Clinical consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabian Esamai, PhD

Role: STUDY_CHAIR

Moi University

Locations

Constantine Akwanalo

Eldoret, , Kenya

Countries

Kenya

Other Identifiers

MOiU

Identifier Type: -

Identifier Source: org_study_id