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

Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates: A Quasi-experimental Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06111534
Enrollment
92
Registered
2023-11-01
Start date
2016-02-04
Completion date
2016-09-30
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Pain

Keywords

Healthy infant, Parent participation, Procedural pain

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.

Interventions

BEHAVIORALHolding

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.

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
38 Weeks to 42 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Infant Pain Scale (NIPS)Through painful procedure completion, an average of 10 minutesThe 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

MeasureTime frameDescription
Crying time during the procedureThrough painful procedure completion, an average of 2 minutesThe 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.
Crying time after the procedureThrough painful procedure completion, an average of 2 minutesThe total crying time after the procedure is between when the procedure is completed and the baby calms down.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026