Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates

Not Applicable

Completed

• Conditions: Procedural Pain
• Interventions: Behavioral: Holding

• Registration Number: NCT06111534
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

This study investigated the effect of maternal holding-cuddling (MHC) and paternal holding-cuddling (PHC) on heel prick pain and crying duration in healthy term neonates

Detailed Description

Newborns undergo many painful procedures. The heel prick, or heel lancing, is a painful procedure used for newborn screening tests. It is a more painful procedure than other venipuncture procedures. All pediatricians and healthcare professionals working with neonates should focus on pain management during heel pricks for two reasons. First, they are under an ethical obligation to help neonates experience as little pain as possible during medical procedures. Second, repeated painful exposure has harmful consequences. The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) also recommends pharmacological and non-pharmacological methods to prevent and effectively manage acute procedural pain in children. However, pharmacological methods for pain management in neonates may have some side effects. On the other hand, non-pharmacological methods are easy to use, affordable, and time-effective methods with no side effects. Healthcare professionals do not use non-pharmacological methods that are expensive, hard to apply, and time-consuming. Therefore, this study focused on maternal holding-cuddling and paternal holding-cuddling as alternative non-pharmacological methods to prevent procedural pain in neonates during heel pricks. Holding-cuddling is an effective non-pharmacological method for reducing procedural pain.

Study Timeline

• Study Start: 2016-02-04
• Primary Completion: 2016-08-20
• Study Completion: 2016-09-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• healthy term neonates
• birth weight between 2500 and 4000 g
• 38-42 gestational week
• postnatal age of 48-72 hours
• a 5-minute APGAR score of ≥8,
• having had no experience of any painful interventions other than vitamin K and hepatitis B vaccine at birth
• fed between 30 and 60 min before the procedure
• undergoing heel prick only once
• blood collection for the Guthrie test
• willing to hold their babies during the procedure

Exclusion Criteria

• sleeping during the procedure
• receiving analgesics up to 24 hours before the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MHC group	Holding	Each MHC group participant (n=30) was brought to the procedure room by its mother. The mother sat in a comfortable chair with back support. She held her baby close to her chest, with the baby's head in a crossed position so that it could see its mother. The same nurse collected the blood sample. The mother communicated with the baby verbally and made eye contact with it to calm it down during the procedure. She was holding the baby both during and after the procedure.
PHC group	Holding	Each PHC group participant (n=30) was brought to the procedure room by its father. The father sat in a comfortable chair with back support. He held his baby close to his chest, with the baby's head in a crossed position so that it could see its father. The same nurse collected the blood sample. The father communicated with the baby verbally and made eye contact with it to calm it down during the procedure. He was holding the baby both during and after the procedure.

Primary Outcome Measures

Name	Time	Method
Neonatal Infant Pain Scale (NIPS)	Through painful procedure completion, an average of 10 minutes	The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.

Secondary Outcome Measures

Name	Time	Method
Crying time after the procedure	Through painful procedure completion, an average of 2 minutes	The total crying time after the procedure is between when the procedure is completed and the baby calms down.
Crying time during the procedure	Through painful procedure completion, an average of 2 minutes	The duration of total crying time during the procedure is between when the heel is pricked and the injection site is covered with a cotton pad.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Kadıköy, Turkey