Clinical trial NCT05001191: The Effect of Gentle Human Touch in Preterm Infants During Heel Lancing
Official title: The Effect of Gentle Human Touch on Pain, Comfort and Physiological Parameters in Preterm Infants During Heel Lancing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heel Lancing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. The study will be performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. The therapeutic touch will be applied 10 minutes before the heel lancing, it will continue during and after the procedure, a total of 15 minutes of sensitive touch will be applied. The practitioner will place one hand on the baby's head and the other hand on the lower abdomen covering the waist and hips of the preterm baby for 15 minutes. Before and after the study the following were evaluated in preterm infants in the gentle human touch and control group: pain, comfort and physiological parameters.

Detailed description: This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. The research sample will consist of 50 preterm infants who meet the inclusion criteria. In the literature, the number of infants varies between 11 and 38 in different studies in which gentle human touch was applied to preterm infants. In this study, it was decided that the number of infants in the groups should be 25 according to α=95% confidence level and 90% power. In the study, it was planned to have 25 infants in the gentle human touch (GHT) and control groups. After reaching 50 preterm infants in the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not. The infants in the GHT group will be applied gentle human touch for a total of 15 minutes, starting 10 minutes before the heel lancing and continuing during the heel lancing. The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made. Being 32-37 gestational age weeks, being birth weight of 1500 g and above, without a congenital anomaly, not having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis, no chest tube, not connected to a mechanical ventilator, not having intracranial bleeding, not taking any medication other than antibiotics and vitamin supplements, not taking opiates and sedatives within 4 hours before heel lancing, no painful intervention is applied at least one hour before the heel lancing, preterm infants whose mothers gave verbal and written consent will be included in the study. Data will be collected with the Questionnare Form, Physiological Parameters Observation Form, Neonatal Infant Pain Scale (NIPS), Premature Infant Comfort Scale (PBIC) and Pulse Oximeter.

Eligibility criteria: Inclusion Criteria:

* Being 32-37 gestational age weeks,
* being birth weight of 1500 g and above,
* without a congenital anomaly, not having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis,
* no chest tube,
* not connected to a mechanical ventilator,
* not having intracranial bleeding,
* not taking any medication other than antibiotics and vitamin supplements,
* not taking opiates and sedatives within 4 hours before heel lancing,
* no painful intervention is applied at least one hour before the heel lancing,
* preterm infants whose mothers gave verbal and written consent

Exclusion Criteria:

* having a congenital anomaly, having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis,
* being chest tube,
* connected to a mechanical ventilator,
* having intracranial bleeding,
* taking any medication other than antibiotics and vitamin supplements,
* taking opiates and sedatives within 4 hours before heel lancing,
* painful intervention is applied at least one hour before the heel lancing

Primary outcomes:
measure: Premature infants comfort scale (PICS) scores
timeFrame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
Secondary outcomes:
measure: Newborn infant pain scale (NIPS) scores
timeFrame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
Other outcomes:
measure: physiological parameters- heart rate
timeFrame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
measure: physiological parameters- respiratory rate
timeFrame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
measure: physiological parameters- oxygen saturation
timeFrame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
measure: physiological parameters- crying time
timeFrame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
Locations:
city: Kayseri
country: Turkey
facility: Erciyes university
Study officials:
affiliation: ErciyesUniversity
name: Yağmur Sezer Efe, Assist. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.