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

NCT06111534 | Completed

• 1 other identifier: 2016/13173
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Procedural Pain

Keywords

Healthy infant; Parent participation; Procedural pain

Outcome Measures

Primary Outcomes (1)

• Neonatal Infant Pain Scale (NIPS)

  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.

  Through painful procedure completion, an average of 10 minutes

Secondary Outcomes (2)

• Crying time during the procedure

  Through painful procedure completion, an average of 2 minutes

• Crying time after the procedure

  Through painful procedure completion, an average of 2 minutes

Study Arms (3)

MHC group

EXPERIMENTAL

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.

Behavioral: Holding

PHC group

EXPERIMENTAL

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.

Behavioral: Holding

Control group

NO INTERVENTION

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.

Interventions

Holding 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.

MHC group; PHC group

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy term neonates
• birth weight between 2500 and 4000 g
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30447813 BACKGROUND

• 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.

  PMID: 32601011 BACKGROUND

• 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.

  PMID: 21893645 BACKGROUND

• 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.

  PMID: 8413140 BACKGROUND

• 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.

  PMID: 27751753 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aynur Aytekin Özdemir, PhD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: February 4, 2016
• Primary Completion: August 20, 2016
• Study Completion: September 30, 2016
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)