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

NCT05001191 | Completed

• 1 other identifier: 2021/453
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heel Lancing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Newborn infant pain scale (NIPS) scores

  before the heel lancing, during the heel lancing and after heel lancing 15. minute

Other Outcomes (4)

• physiological parameters- heart rate

  before the heel lancing, during the heel lancing and after heel lancing 15. minute

• physiological parameters- respiratory rate

  before the heel lancing, during the heel lancing and after heel lancing 15. minute

• physiological parameters- oxygen saturation

  before the heel lancing, during the heel lancing and after heel lancing 15. minute

Study Arms (2)

Gentle Human Touch Group

EXPERIMENTAL

Other: Gentle Human Touch

Control group

NO INTERVENTION

Interventions

Gentle Human Touch 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.

Gentle Human Touch Group

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes university

Kayseri, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35759976 DERIVED

Study Officials

• Yağmur Sezer Efe, Assist. Prof.

  ErciyesUniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Yağmur Sezer Efe

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 11, 2021
• Study Start: August 10, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)