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

NCT06196502 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-09

No results posted yet for this study

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

Interventions

OTHER

Gentle Human Touch (GHT)

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.

OTHER

Kangaroo Care

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.

OTHER

Lactation

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

Sponsors & Collaborators

  • Kirsehir Ahi Evran Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-07-30
Completion
2024-08-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06196502 on ClinicalTrials.gov