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

NCT05857423 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Infant, Premature

Interventions

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.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2023-12-30
Completion
2023-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857423 on ClinicalTrials.gov