Clinical trial NCT06111534: Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates
Official title: Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Keywords: Healthy infant
Parent participation
Procedural pain
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 92
Sex: ALL
Minimum age (years): 38
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: Through painful procedure completion, an average of 10 minutes
Secondary outcomes:
measure: Crying time during the procedure
timeFrame: Through painful procedure completion, an average of 2 minutes
measure: Crying time after the procedure
timeFrame: Through painful procedure completion, an average of 2 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: Istanbul Medeniyet University
name: Aynur Aytekin Özdemir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perry M, Tan Z, Chen J, Weidig T, Xu W, Cong XS. Neonatal Pain: Perceptions and Current Practice. Crit Care Nurs Clin North Am. 2018 Dec;30(4):549-561. doi: 10.1016/j.cnc.2018.07.013.
citation: Dur S, Caglar S, Yildiz NU, Dogan P, Guney Varal I. The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing. Intensive Crit Care Nurs. 2020 Dec;61:102886. doi: 10.1016/j.iccn.2020.102886. Epub 2020 Jun 27.
citation: Johnston CC, Campbell-Yeo M, Filion F. Paternal vs maternal kangaroo care for procedural pain in preterm neonates: a randomized crossover trial. Arch Pediatr Adolesc Med. 2011 Sep;165(9):792-6. doi: 10.1001/archpediatrics.2011.130.
citation: Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
citation: Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15.