The Comparison of Gentle Human Touch's Effect by Mother and Nurse on Pain Level During Heel Blood Sampling in Preterm Infants

May 4, 2023 updated by: Cansu Avlac, Istanbul University - Cerrahpasa (IUC)
This study is an experimental randomized controlled study conducted to compare the effect of gentle human touch applied by mother and nurse on pain level during heel blood sampling in preterm infant. The population of the study consists of preterm infants who stay neonatal intensive care unit of state hospital and whose heels blood sampling will be collected. The number of samples for this study was determined as 40 preterm infants with theoretical power of 95%. This study will be started when the researcher informs the families of preterm infants about the research and receives written and oral consent. The preterm infants were divided into 2 groups of 20 preterm infants, including control group who are applied gentle human touch by nurses and the experimental group who are applied gentle human touch by mothers. In the study, the randomization of the sample group was performed through the website named www.randomizer.org. The researcher records physiological measurements (heart rate and oxygen saturation) and the NIPS score before heel lancing. The gentle human touch procedure will be applied to infants in both groups for 10 minutes and then blood will be drawn from the infants' heels. Intervention assessment (KTA, oxygen saturation, and NIPS) will be done after the preterm infant's heel is pricked. The time will be kept when the needle is pricked and the procedure time will be recorded when the blood collection is finished. The time will be kept as soon as the baby starts to cry and the crying time will be recorded when the crying ends. Evaluation of the NIPS/Neonatal Pain Scale will be done by the researcher and a nurse outside the study. Then, inta-rater reliability will be evaluated. After the blood collection, Gentle Human Touch application will be continued for 5 more minutes. At the end of this period, the heart rate, oxygen saturation and NIPS score will be evaluated again.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The hypotheses of the research are as follows:

  • Ho: There is no significant difference between the effect of gentle human touch applied by the mother during heel prick procedure of preterm infants on neonatal pain level (NIPS: Neonatal Infant Pain Scale), heart rate, O2 saturation, and crying time, and the effect of gentle human touch applied by the nurse on pain level.
  • H1: The NIPS score of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be lower than the neonates who received gentle human touch from the nurse.
  • H2: The heart rate of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be lower than the neonates who received gentle human touch from the nurse.
  • H3: The O2 saturation of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be higher than the neonates who received gentle human touch from the nurse.
  • H4: The crying time of neonates who received gentle human touch from their mother during heel prick procedure of preterm infants will be shorter than the neonates who received gentle human touch from the nurse.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gestational age between 32 and 36 weeks,
  • Birth weight 1200 gr or more,
  • APGAR score more than 6 at 5 minute,
  • No intracranial hemorrhage higher than Grade II,
  • Must have a hemodynamic stability (infants receiving ventilator respiratory support, sepsis, cyanosis and heart disease are not included in the sampling),
  • Not taking opiates and sedatives within 4 hour before heel lancing,
  • No painful procedure was performed 1 hour ago before heel lancing,

Exclusion Criteria:

  • Having a congenital anomalies,
  • Having a skin disease,
  • Receiving respiratory support with a mechanical ventilator,
  • Having a surgical operation,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Preterm infants who are applied gentle human touch by nurses
Other: Gentle Human Touch

Gentle Human Touch procedure has 3 step as follows:

  1. Mother/nurse must wash their hands with antimicrobial soap for 3 minutes before starting Gentle Human Touch procedure.
  2. Next, mother/nurse must warm their hands.
  3. Mother/nurse must place their one hand on the infant's head and the other hand on the lower abdomen that covers the waist and hips of the preterm infant, for 15 minute.
Experimental: Experimental Group
Preterm infants who are applied gentle human touch by mother
Other: Gentle Human Touch

Gentle Human Touch procedure has 3 step as follows:

  1. Mother/nurse must wash their hands with antimicrobial soap for 3 minutes before starting Gentle Human Touch procedure.
  2. Next, mother/nurse must warm their hands.
  3. Mother/nurse must place their one hand on the infant's head and the other hand on the lower abdomen that covers the waist and hips of the preterm infant, for 15 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain on the Neonatal Infant Pain Scale (NIPS) at 5 minutes after the heel lancing
Time Frame: Baseline and 5 minutes after the heel lancing

This scale, behavioral responses to pain as facial expression, crying, breathing pattern, arms, legs, and alertness are evaluated. The preterm infant get a score between 0-7 and is considered to have pain if it gets a score greater than 3.

Change=(5 minutes after score- baseline score)
Baseline and 5 minutes after the heel lancing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 10, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

March 25, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IstanbulUCCansuAvlaç0000000001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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