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Clinical Trials/NCT06436404
NCT06436404
Completed
Not Applicable

Effect of Two Different Positions on Pain, Stress, Comfort and Physiological Parameters of the Premature Infants: Randomized Controlled Trial

Nigde Omer Halisdemir University1 site in 1 country42 target enrollmentJanuary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant Development
Sponsor
Nigde Omer Halisdemir University
Enrollment
42
Locations
1
Primary Endpoint
Determining the descriptive characteristics of babies
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.

Detailed Description

Providing adequate therapeutic positioning in preterms can minimize postural abnormalities and asymmetries associated with prematurity and NICU stay, as well as support the development of spontaneous and functional motor abilities of infants. Studies show that positioning directly affects cardiovascular, respiratory and sleep-wake states. When the literature is examined; Although the vital signs, pain levels and comfort levels of babies in the NICU have been examined in many applications, the number of studies comparing the hammock position and Kangaroo care in preterms is very limited. Therefore, this study will try to determine the effect of hammock position and kangaroo care on the pain, stress, comfort and physiological parameters of the infants. It is thought that the study will provide new data to the literature and lead to many researches.

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
May 20, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nigde Omer Halisdemir University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Infants having at least 2 days of inpatient treatment from,
  • Infants 32-36+
  • being born during the gestational week,
  • Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
  • Apgar score above 6 at the 5th minute Infants will included.

Exclusion Criteria

  • Infants having at least 2 days of inpatient treatment from,
  • Infants 32-36+
  • being born during the gestational week,
  • Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
  • Apgar score above 6 at the 5th minute Infants will included.

Outcomes

Primary Outcomes

Determining the descriptive characteristics of babies

Time Frame: 1 hour

1- Infant Introductory Form: The form includes introductory information about the baby (Postnatal day, gestational age, birth weight (g), weight on the day of the intervention, type of birth, gender, postnatal age, physiological weight loss, feeding style, 1st and 5th minute Apgar score, maternal age. It consists of questions containing).

Hammock position and Kangaroo care increase comfort level in preterm infants

Time Frame: 1 hour

2- The COMFORT-behavior scale (COMFORTneo): It is a Likert-type scale developed to be used in evaluating the sedation and comfort needs, pain and distress of newborns monitored in intensive care. The scale was revised for newborns. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.

Hammock position and Kangaroo care decrease pain and stress level in preterm infants

Time Frame: 1 hour

3- ALPS-Neo "Newborn Pain and Stress Assessment Scale": The scale was developed in 2014 to evaluate pain and stress in premature and term newborns. Measurement is made through observation. As the score obtained increases, stress and pain increase.

Secondary Outcomes

  • Hammock position and Kangaroo care support physiological stability in premature infants.(1 hour)

Study Sites (1)

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