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

NCT ID: NCT05001191

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2021-09-10

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.

Conditions

Heel Lancing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Gentle Human Touch Group

Group Type: EXPERIMENTAL

Gentle Human Touch

Intervention Type: OTHER

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.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Yağmur Sezer Efe

Assist. Prof. Yağmur Sezer Efe

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yağmur Sezer Efe, Assist. Prof.

Role: PRINCIPAL_INVESTIGATOR

ErciyesUniversity

Locations

Erciyes university

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35759976 (View on PubMed)

Other Identifiers

2021/453

Identifier Type: -

Identifier Source: org_study_id