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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06350084
Other study ID # 2023/381
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Burdur Mehmet Akif Ersoy University
Contact Selda Ates Besirik, PhD.
Phone +905076228189
Email seldaates07@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Days to 4 Days
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Burdur Bucak State Hospital Burdur Bucak

Sponsors (1)

Lead Sponsor Collaborator
Burdur Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary NIPS (Neonatal Infant Pain Scale) 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 Crying times Duration of crying were recorded. during the heel blood collection procedures (average 10 minutes)
Secondary Processing time Duration of heel blood collection procedure were recorded. during the heel blood collection procedures (average 10 minutes)
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