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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-04

Study Completion Date

2016-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Procedural Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Participants were recruited using random sampling. The group assignment was determined using the closed envelope method. Therefore, data were collected first from the MHC group, followed by the PHC and control groups.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MHC group

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.

Group Type EXPERIMENTAL

Holding

Intervention Type BEHAVIORAL

Holding is an effective non-pharmacological method for reducing procedural pain. Minor painful procedures, such as heel pricks, are easy to use, practical, non-invasive, and affordable procedures when performed when the neonate is held/cuddled by one of its parents. Neonates held/cuddled by their mothers are likely to experience less pain and cry less during heel pricks. The MHC and PHC methods help neonates experience tactile, auditory, visual, and olfactory sensory inputs that can enhance analgesic effects. These multisensory methods can alleviate the pain experienced by the infant during minor painful procedures and shorten the crying time. This type of analgesia may be mediated by multisensory stimulation associated with the mother/father-infant attachment.

PHC group

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.

Group Type EXPERIMENTAL

Holding

Intervention Type BEHAVIORAL

Holding is an effective non-pharmacological method for reducing procedural pain. Minor painful procedures, such as heel pricks, are easy to use, practical, non-invasive, and affordable procedures when performed when the neonate is held/cuddled by one of its parents. Neonates held/cuddled by their mothers are likely to experience less pain and cry less during heel pricks. The MHC and PHC methods help neonates experience tactile, auditory, visual, and olfactory sensory inputs that can enhance analgesic effects. These multisensory methods can alleviate the pain experienced by the infant during minor painful procedures and shorten the crying time. This type of analgesia may be mediated by multisensory stimulation associated with the mother/father-infant attachment.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Holding

Holding is an effective non-pharmacological method for reducing procedural pain. Minor painful procedures, such as heel pricks, are easy to use, practical, non-invasive, and affordable procedures when performed when the neonate is held/cuddled by one of its parents. Neonates held/cuddled by their mothers are likely to experience less pain and cry less during heel pricks. The MHC and PHC methods help neonates experience tactile, auditory, visual, and olfactory sensory inputs that can enhance analgesic effects. These multisensory methods can alleviate the pain experienced by the infant during minor painful procedures and shorten the crying time. This type of analgesia may be mediated by multisensory stimulation associated with the mother/father-infant attachment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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