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Completed

NCT Number: NCT05948098

Facilitated Tucking Position, Gentle Human Touch Practices and Pain

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.

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Key information

Conditions

Pain Female Urogenital Diseases and Pregnancy Complications Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Premature Birth Signs and Symptoms Urogenital Diseases

Age range

34 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adıyaman University

Adıyaman, Turkey (Türkiye)

About this study

Neonatal pain negatively affects prognosis, behavior, environmental adaptation, development of the brain and senses, and interaction. Effective management of neonatal pain supports health and recovery, shortens hospital stays, and reduces care costs and the prevalence of neurobehavioral problems. Therefore, proper management of pain in newborns is important for the healthy development of newborns. Many invasive procedures are applied to newborns hospitalized in neonatal intensive care units. Non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and gentle human touch have proven to have positive effects on the pain experienced by newborns during interventional procedures. In this study, the effect of facilitated tucking position and gentle human touch practices applied during heel blood collection on the perception of pain in premature newborns will be examined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature newborns (34-37 weeks of gestation), dependent on nasal CPAP, without congenital anomalies, not taking sedative or analgesic drugs, not receiving oral feeding, and whose parents approved to participate in the study will be included in the study.

Exclusion criteria

  • Newborns with open wounds on their body, bleeding disorders, and those who underwent a painful procedure just before heel blood sampling will not be included in the study.

Treatment and study plan

Facilitated Tucking Position

Behavioral

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

Gentle Human Touch

Behavioral

It is a form of healing touch

Primary outcomes

  1. Neonatal Pain Diagnostic Scale (NIPS)

    Time frame: 1 minutes

    It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım 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.

Secondary outcomes

  1. Pulse Oximeter Device

    Time frame: 1 minutes

    It was used for the measurement of oxygen saturation and heart rate before, during and after heel lancing in all three groups.

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

The Effect of Facilitated Tucking Position and Gentle Human Touch Practices on the Perception of Pain During Heel Blood Collection in Premature Newborns

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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