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

Istanbul Medeniyet University

Status: Completed

Conditions: Procedural Pain

Treatments: Behavioral: Holding

Study type: Interventional

Funder types: Other

Identifiers

NCT06111534

2016/13173

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 38 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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92 participants in 3 patient groups

MHC group

Experimental group

Description:

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.

Treatment:

Behavioral: Holding

PHC group

Experimental group

Description:

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.

Treatment:

Behavioral: Holding

Control group

No Intervention group

Description:

The control group participants (n=32) underwent the procedure according to the routine clinical practice. Either parent brought the baby into the procedure room and laid it on the procedure table in the supine position. The nurse collected the blood sample. The parent was present in the room and communicated with the baby only verbally during the procedure. The parent picked up the baby after the procedure.