Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The Newborn Infant Pain Scale (NIPS)
Study Overview
Brief Summary
This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.
Detailed Description
The randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. The infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
The two separate clinicians conducting the assessment were masked to allow for impartiality.
Eligibility Criteria
- Ages
- 2 Days to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Gestational age of 38-41 weeks,
- •Chronological age of 2-28 days,
- •Without any physical, metabolic or genetic disease,
- •Newborns who did not use any analgesic drugs before the procedure
Exclusion Criteria
- •Newborns whose heel blood cannot be taken at once
Arms & Interventions
Control Group
Routine heel blood was taken from the control group. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was watched and scored by two midwives who had training in the Neonatal Pain Scale.
Experimental Group
The newborns in the experimental group listened to the recorded heart sounds of their mothers for 1 minute before the heel blood procedure, during the procedure and for 1 minute after the procedure. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was monitored and scored by two midwives trained in the Neonatal Pain Scale.
Intervention: Listening the maternal heart sound during the invasive interventions (Other)
Outcomes
Primary Outcomes
The Newborn Infant Pain Scale (NIPS)
Time Frame: 15 minutes
The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.
Secondary Outcomes
No secondary outcomes reported