The Effect of Gentle Human Touch in Preterm Infants During Heel Lancing

The Effect of Gentle Human Touch on Pain, Comfort and Physiological Parameters in Preterm Infants During Heel Lancing

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.

Study Overview

• Status: Completed
• Conditions: Heel Lancing
• Intervention / Treatment: Other: Gentle Human Touch

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey
    • Erciyes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Gentle Human Touch Group	Other: Gentle Human Touch; Gentle human touch, which has a pain and stress-reducing effect, is a sensitive tactile stimulus applied to the skin, without caress or massage, which provides a kind of relaxation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature infants comfort scale (PICS) scores	According to the PICS, a score between 7-35 is obtained from the scale. A high score from the scale indicates a low level of comfort. Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )	before the heel lancing, during the heel lancing and after heel lancing 15. minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn infant pain scale (NIPS) scores	A score between 0-7 is taken from the scale. As the score increases, the severity of the pain also increases (0-2 points no pain, 3-4 points moderate pain, and >4 points severe pain). Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )	before the heel lancing, during the heel lancing and after heel lancing 15. minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiological parameters- heart rate	heart rate. Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )	before the heel lancing, during the heel lancing and after heel lancing 15. minute
physiological parameters- respiratory rate	respiratory rate. Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )	before the heel lancing, during the heel lancing and after heel lancing 15. minute
physiological parameters- oxygen saturation	oxygen saturation. Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )	before the heel lancing, during the heel lancing and after heel lancing 15. minute
physiological parameters- crying time	crying time. Change= (before the heel lancing, during the heel lancing and after heel	before the heel lancing, during the heel lancing and after heel lancing 15. minute

Collaborators and Investigators

• Sponsor: TC Erciyes University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021/453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No