NCT06196502

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

Status unknown NA Last updated 9 January 2024

What this trial tests

NA trial testing Gentle Human Touch (GHT) in Pain in 80 participants. Status unknown.

Timeline

1 February 2024

Primary endpoint
30 July 2024

30 August 2024

Quick facts

Lead sponsor	Kirsehir Ahi Evran Universitesi
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	80
Start date	1 February 2024
Primary completion	30 July 2024
Estimated completion	30 August 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Gentle Human Touch (GHT)
• Kangaroo Care
• Lactation

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Kirsehir Ahi Evran Universitesi — full company profile →

Who can join

Adults 1 Day to 2 Days, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.