PAIN, PAIN MANAGEMENT
Conditions
Keywords
Heel prick, breastfeeding, breast milk, non-pharmacological analgesia, facilitated tucking
Brief summary
This randomized clinical trial evaluated whether a non-pharmacological Triple Combination of expressed breast milk, sucking, and facilitated tucking reduced pain during heel prick in healthy term newborns compared with Breastfeeding (Tetanalgesia). The study included healthy term newborns with a gestational age of 37 weeks or more whose parents provided informed consent in the maternity unit of Hospital Comarcal de Vinaròs, Spain. Pain and response to the procedure were assessed by comparing the two groups, and two investigators who were not involved in data collection independently reviewed the video recordings to assign pain scores.
Detailed description
The study was designed as a randomized, single-blind clinical trial with two study groups. Healthy term newborns were recruited consecutively from January 2021 to March 2023 in the maternity unit of Hospital Comarcal de Vinaròs (Castellón, Spain). After informed consent was obtained from parents or legal representatives, participants were allocated by simple randomization using sealed envelopes to one of two study groups: Triple Combination or Breastfeeding (Tetanalgesia). In the Triple Combination group, neonates were placed in a lateral flexed position with the arms and legs close to the trunk. Sucking with a pacifier or finger was started 2 minutes before the heel prick and continued until 2 minutes after the procedure. During the procedure, 1 to 2 mL of freshly expressed breast milk was administered by syringe, while facilitated tucking was maintained throughout the procedure and for 2 minutes afterward. In the Breastfeeding (Tetanalgesia) group, neonates were breastfed during the heel prick while being held in their mothers' arms. The procedure started after approximately 2 minutes of effective sucking and ended 2 minutes after the heel prick. Pain outcomes were assessed using the Premature Infant Pain Profile (PIPP) and the Neonatal Infant Pain Scale (NIPS). Additional outcomes included heart rate and oxygen saturation at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick, as well as crying duration in seconds from the start of the heel prick until crying ceased, assessed up to 5 minutes after heel prick. Two independent investigators who were not involved in data collection reviewed the video recordings to assign pain scores.
Interventions
PROCEDURETriple Combination
Triple Combination intervention administered during heel prick.
PROCEDUREBreastfeeding (Tetanalgesia)
Breastfeeding (Tetanalgesia) intervention administered during heel prick.
Sponsors
Universitat Jaume I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors reviewing the video recordings were blinded to group allocation.
Intervention model description
Participants were randomized to one of two parallel groups, Triple Combination or Breastfeeding (Tetanalgesia), and remained in the assigned group for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
47 Years to 52 Years
Healthy volunteers
No
Inclusion criteria
* Healthy term newborns with a gestational age of 37 weeks or later. * Breastfed newborns. * Newborns undergoing heel prick. * Written informed consent obtained from a parent or legal guardian.
Exclusion criteria
* Formula-fed newborns. * Newborns admitted to the pediatric unit for any medical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total score on the Premature Infant Pain Profile (PIPP) | During the heel prick procedure. | Total score on the Premature Infant Pain Profile (PIPP), assessed in term newborns (gestational age ≥37 weeks) during the heel prick procedure using a 15 second behavioral observation period and a 30 second physiological/facial observation period. Possible scores range from 0 to 18, with higher scores indicating worse pain. |
| Total score on the Neonatal Infant Pain Scale (NIPS) | During the heel prick procedure. | Total score on the Neonatal Infant Pain Scale (NIPS), assessed during the heel prick procedure. The scale evaluates five behavioral responses and one physiological response to procedural pain. Possible scores range from 0 to 7, with higher scores indicating worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to cessation of crying | Up to 5 minutes after heel prick. | Time from the start of the heel prick until cessation of crying, measured in seconds. |
| Mean heart rate | Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick. | Mean heart rate, measured in beats per minute, recorded in term newborns (gestational age ≥ 37 weeks) at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick. |
| Mean oxygen saturation (SpO2) | Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick. | Mean oxygen saturation (SpO2), measured as percentage, recorded in term newborns (gestational age ≥37 weeks) at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick. |
Countries
Spain
Outcome results
None listed