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

NCT ID: NCT06350084

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2025-02-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Acute Newborn Crying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mother's Touch

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Nurse's Therapeutic Touch

Intervention Type BEHAVIORAL

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.

Control Group

In this group, infants received routine heel blood collection procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

2 Days

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role lead

Responsible Party

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Selda Ateş Beşirik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selda Ateş Beşirik, PhD.

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Emine Geçkil, Professor

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

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Burdur Bucak State Hospital

Burdur, Bucak, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/381

Identifier Type: -

Identifier Source: org_study_id

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