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Facilitated Tucking Position, Gentle Human Touch Practices and Pain

NCT05948098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-10-24

No results posted yet for this study

Summary

This prospective study is planned as a randomized controlled study to evaluate the effect of facilitated tucking position and gentle human touch practices on the pain experienced by newborns during heel blood collection. This study is planned to be carried out between 15 July and 15 December 2023 in the neonatal intensive care unit of a training and research hospital in the Southeastern Anatolia Region. The sample size was calculated based on the study of premature infants to determine the effect of facilitated tucking position on procedural pain. According to the results of the study, PIPP pain scores were determined as 11.88±3.05 in the intervention group (n=17) and 9.06±2.95 in the control group (n=17). The effect size of the study was determined as d= 0.939 at α=0.05 level and 95% confidence interval. It was decided to conduct the study with a total of 90 premature babies, 30 of whom were in the groups, in case of data loss during the study.

Conditions

Interventions

BEHAVIORAL

Facilitated Tucking Position

a sub-form of method of nesting the baby and the procedure of bringing the body to middle or even close position by holding the upper and lower extremities of the baby in flexion with hands

BEHAVIORAL

Gentle Human Touch

It is a form of healing touch

Sponsors & Collaborators

  • Adiyaman University Research Hospital

    lead OTHER

Principal Investigators

  • Tuba Koç Özkan · Adiyaman University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
34 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2023-09-21
Completion
2023-10-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT05948098 on ClinicalTrials.gov