The Effect of Gentle Human Touch and Kangaroo Care on Pain and Crying Physiological Parameters During Hepatitis-B Vaccination in a Newborn

NCT06196502 | Unknown

• 1 other identifier: AhiEvranU-UTubaKOÇ-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Many short- and long-term consequences, including altered physiological parameters, issues with feeding and sleep, chronic pain syndrome, difficulty focusing, anxiety, cognitive behavioral disorders, adjustment disorders, and growth retardation, have been linked to pain in neonates. Each and every newborn is entitled to pain relief and reduction. Avoiding painful interventions is the most crucial tactic in the management of newborn pain. However, it is impossible to ignore the necessity of therapeutic and diagnostic interventions. As such, pain reduction and elimination are crucial. Non-pharmacological techniques used on infants undergoing invasive operations have been shown in studies to be successful in reducing discomfort, pain, and restlessness while also enhancing comfort. Numerous non-invasive, non-pharmacological techniques are employed for this goal. Among the non-invasive, non-pharmacological techniques include breastfeeding, nursing, therapeutic touch, skin-to-skin contact, wrapping, swaddling, music therapy, and white noise. The Hepatitis-B vaccine is among the first invasive therapies administered to infants. Research indicates that pain scores are positively impacted by canopy touch. Skin-to-skin contact is achieved by a number of techniques. The most popular is kangaroo care, which is given to mothers nude on their chests. Gentle human touch is another technique used to lessen pain during invasive operations (GHT). GHT is a soothing tactile stimulation that doesn't involve touching or rubbing. Several research have examined GHT's impact and discovered that it effectively reduces pain. The purpose of this study was to ascertain how GHT and Kangaroo care affected the newborn's pain, length of crying, and physiological parameters while the Hepatitis-B vaccine was being administered. The researchers at the Kirsehir Training and Research Hospital in Turkey will apply their findings to healthy newborns who are placed adjacent to their moms in the postpartum ward. The researchers have experience in neonatal critical care nursing and are qualified in therapeutic touch.

Conditions

Pain

Keywords

newborn; pain; intervention; pediatric nursing; vaccination

Outcome Measures

Primary Outcomes (1)

• pain level

  The newborn's pain assessment will be measured by NIPS. In the scale, the baby's facial expression (0-1 point), crying (0-2 points), breathing pattern (0-1 point), arm movements (0-1 point), leg movements (0-1 point) and alertness ( Scores between 0-7 are given according to 0-1 points). An increase in the score on the scale indicates a higher severity of pain.

  before vaccination/ immediately after vaccination

Secondary Outcomes (4)

• newborn crying duration

  immediately after vaccination

• Saturation

  before vaccination/ immediately after vaccination

• Heart rate

  before vaccination/ immediately after vaccination

• Respiratory rate

  before vaccination/ immediately after vaccination

Study Arms (3)

Gentle human touch (GHT)

EXPERIMENTAL

Experimental: Gentle human touch (GHT) Group 1: Gentle touch is a touch technique that provides a kind of relaxation in premature babies, reduces behavioral stress and motor activities of babies and is effective in their positive behavior.

Other: Gentle Human Touch (GHT)

Kangaroo Care

ACTIVE COMPARATOR

Experimental: Kangaroo Care Group 2: Kangaroo care is a comforting technique that strengthens and bonds the baby and parent, increases the production of milk by the mother, and lessens the stress and anxiety of both parties. Kangaroo care between parent and baby is a method that regulates vital values, reduces the possibility of hypoglycemia and prevents hypothermia.

Other: Kangaroo Care

Lactation

ACTIVE COMPARATOR

Breastfeeding will begin 5 minutes before the Hepatitis-B vaccine administration and will continue during and after the procedure. It is planned to last 10 minutes in total.

Other: Lactation

Interventions

Gentle Human Touch (GHT) OTHER

Gentle touch is a touch technique that provides a kind of relaxation in premature babies, reduces behavioral stress and motor activities of babies and is effective in their positive behavior. GHT Hepatitis-B vaccine will start 5 minutes before the application and continue during and after the procedure. It is planned to take 10 minutes in total. The researcher will place one hand on the baby's head and the other hand on the baby's lower abdomen, covering the waist and hips, for 10 minutes.

Gentle human touch (GHT)

Kangaroo Care OTHER

Kangaroo care will be provided to randomly selected volunteer moms in their own gynecological ward rooms, where they will have skin-to-skin contact with their babies while maintaining their privacy. Kangaroo care is a strategy that promotes bonding and engagement between a mother and her infant by allowing skin-to-skin contact with the newborn's face facing the mother and only the diaper remaining. The infant is positioned such that his or her shoulders are totally on the mother's chest, ensuring the baby's airway is open. To avoid heat loss while the baby is in skin-to-skin contact with his mother, a tiny blanket will be placed on his back and a beanie will be placed on his head. Kangaroo care will begin 5 minutes before the Hepatitis-B vaccine is administered and will continue throughout the operation. It is estimated that it will take 10 minutes in total.

Kangaroo Care

Lactation OTHER

Breastfeeding will become standard medical practice. Breastfeeding will start as soon as the baby is given the vaccination and continue throughout the process.

Lactation

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational week between 38-42,
• Born at 38 weeks or above and with a body weight of \>2500 grams,
• Apgar score 1st and 5th 7 and above per minute,
• Mothers who speak and speak Turkish

You may not qualify if:

• Congenital anomaly
• Hospitalization of the baby in the neonatal intensive care unit after birth
• Mothers with hepatitis B vaccine refusal
• Mothers who do not have kangaroo care

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (5)

• Uematsu H, Sobue I. Effect of music (Brahms lullaby) and non-nutritive sucking on heel lance in preterm infants: A randomized controlled crossover trial. Paediatr Child Health. 2019 Feb;24(1):e33-e39. doi: 10.1093/pch/pxy072. Epub 2018 Jul 24.

  PMID: 30792607 BACKGROUND

• Im H, Kim E. Effect of Yakson and Gentle Human Touch versus usual care on urine stress hormones and behaviors in preterm infants: a quasi-experimental study. Int J Nurs Stud. 2009 Apr;46(4):450-8. doi: 10.1016/j.ijnurstu.2008.01.009. Epub 2008 Mar 18.

  PMID: 18353332 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

• Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.

  PMID: 34713833 BACKGROUND

• Sezer Efe Y, Erdem E, Caner N, Gunes T. The effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing. Complement Ther Clin Pract. 2022 Aug;48:101622. doi: 10.1016/j.ctcp.2022.101622. Epub 2022 Jun 22.

  PMID: 35759976 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Kangaroo-Mother Care Method; Lactation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Central Study Contacts

Elif Tuba KOÇ, 1

CONTACT

+905063057819; elif.koc@ahievran.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child Health and Diseases Nursing Department President

Model Details: There are three sections to it, and they will all be finished simultaneously. This is not a study of drugs or devices. The three arms of the study are the breastfeeding (standard care), kangaroo care, and gentle human touch groups.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: January 9, 2024
• Study Start: February 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)