Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection

July 4, 2025 updated by: Selda Ateş Beşirik, Burdur Mehmet Akif Ersoy University

The Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection in Newborns: A Randomized Controlled Study

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.

This study is a prospective, randomized and controlled trial. In this study aim, the effect of Mother's Touch and Nurse's Therapeutic Touch applied during heel blood collection on the pain levels and crying times in newborns will be examined.

Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; Mother's Touch group, Nurse's Therapeutic Touch group, and Control group.

Data were collected using the Infant-family Information Form, NIPS-Neonatal Infant Pain Scale, and Crying Follow-up Form.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bucak
      • Burdur, Bucak, Turkey, 15030
        • Burdur Bucak State Hospital

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:

  • Parents who volunteered and gave consent to participate in the research
  • Full term neonates (38-42 weeks of gestation)
  • Underwent heel stick blood drawing for routine metabolic screening
  • Aged 1 to 4 days
  • Passed the hearing screening
  • Birth weight between 2500-4400 grams
  • Parents who know how to read, write and speak Turkish.

Exclusion Criteria:

  • Parents with any mental problems
  • Infants with any chronic disease and congenital anomalies.

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
Experimental: Mother's Touch Group
Heel blood will be taken while the infant was Mother's Touch. Mother's touch will be applied to the infants before, during and after the procedure.
Behavioral: Mother's Touch
Heel blood will be taken while the infant was Mother's Touch. Mother's touch will be applied to the infants before, during and after the procedure.
Experimental: Nurse's Therapeutic Touch Group
Heel blood will be taken while the infant was Nurse's Therapeutic Touch.Therapeutic Touch will be applied to the infants before, during and after the procedure.
Behavioral: Nurse's Therapeutic Touch
Heel blood will be taken while the infant was Nurse's Therapeutic Touch.Therapeutic Touch will be applied to the infants before, during and after the procedure.
No Intervention: Control Group
In this group, infants received routine heel blood collection procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIPS (Neonatal Infant Pain Scale)
Time Frame: during the heel blood collection procedures (10 minutes)
It was developed in 1993 to evaluate interventional pain in newborns. Its Turkish adaptation was made in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.
during the heel blood collection procedures (10 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crying times
Time Frame: during the heel blood collection procedures (average 10 minutes)
Duration of crying were recorded.
during the heel blood collection procedures (average 10 minutes)
Processing time
Time Frame: during the heel blood collection procedures (average 10 minutes)
Duration of heel blood collection procedure were recorded.
during the heel blood collection procedures (average 10 minutes)

Collaborators and Investigators

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

Sponsor

Burdur Mehmet Akif Ersoy University

Investigators

  • Study Director: Emine Geçkil, Professor, Necmettin Erbakan University
  • Principal Investigator: Selda Ateş Beşirik, PhD., Burdur Mehmet Akif Ersoy University

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 (Actual)

September 4, 2023

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

February 10, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this study, after deidentification, will be shared with researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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

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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