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Clinical Trials/NCT05431452
NCT05431452
Recruiting
N/A

Evaluation of the Effect of Fetal Position, Kangaroo Care, Breast Milk and Combined Fetal Position and Kangaroo Care in Reducing Pain During Heel Blood Collection in Preterm Newborns.

Suleyman Demirel University1 site in 1 country240 target enrollmentMarch 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Suleyman Demirel University
Enrollment
240
Locations
1
Primary Endpoint
Pain management
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Pharmacological and non-pharmacological methods are used to control interventional pain in preterm newborns. Non-pharmacological methods should be preferred in the management of pain, especially during painful minor invasive procedures (blood collection, orogastric tube insertion, aspiration, etc.) applied during the day. Some of these methods are; kangaroo care, breast milk, fetal positioning, breastfeeding, listening to music and massage.

Taking heel blood from babies who are being treated in the neonatal intensive care unit is among the duties, authorities and responsibilities of neonatal intensive care nurses. In addition, the effective management of pain by using non-pharmacological methods is among the professional ethical responsibilities of nurses working in neonatal intensive care units. While fulfilling these responsibilities, nurses should conduct researches with high levels of evidence and benefit from the researches effectively. In this context, determining the most effective non-pharmacological method and activating it in a clinical setting form the basis of nursing practices. In this context, the aim of our research is; The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns.

Detailed Description

The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns. The sample of the study will consist of late preterm newborns who meet the inclusion criteria of the study. It is envisaged that 40 babies will be included in the sample for each group. Randomization will be done in order to provide an equal number of samples for the intervention and control groups in the study. In the randomization to be made, the "simple randomization method" will be used in order to provide equal samples for all three groups. The data of the study will be collected by the clinical nurse working as a nurse in the clinic where the research is conducted, in accordance with the randomization scheme. Physiological parameters of all babies will be monitored on the monitor during the interventions. During the research, all groups will be video-recorded for 10 minutes before the procedure, during the procedure and for 5 minutes after the procedure. After the data of the study are collected, all video recordings will be examined by two researchers (a neonatal intensive care nurse and a neonatal intensive care specialist) and PIPP-R The scale will be filled in by these two independent observers. Descriptive statistics (mean, standard deviation) will be used for the quantitative variables of the research determined by measurement, and descriptive statistics (number, percentage) will be used for the qualitative variables determined by counting. The conformity of the data to be used with the normal distribution will be determined by the Shapiro-Wilk test. In paired comparisons between variables with two categories such as gender, t-test, Analysis of Variance will be applied to find the differences between variables with three or more categories such as group. Paired-sample t-test will be applied between dependent groups for the features that are significant as a result of the analysis of variance. Mann Whitney U test, Wilcoxon test and correlation analyzes will be used to evaluate the relationships between dependent and independent variables. Results will be evaluated at 95% confidence interval and p\<0.05 significance level.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Serife Tutar

Assistant professor

Suleyman Demirel University

Eligibility Criteria

Inclusion Criteria

  • Gestation week between 34(0)/7 - 36(6)/7 weeks
  • Stable physiological condition
  • Able to maintain spontaneous breathing
  • Able to take breast milk
  • Not exposed to a painful procedure at least half an hour before the intervention.
  • Late preterm newborns not taking opioid or non-opioid analgesics will be included in the -study.

Exclusion Criteria

  • Receiving mechanical ventilator support
  • Congenital anomaly
  • Using analgesic/narcotic analgesic drugs
  • Babies who receive treatment with continuous sedation will not be included in the study.

Outcomes

Primary Outcomes

Pain management

Time Frame: 10 month

Management of pain heel puncture in premature newborn. The parameter for pain management will be determined by the Premature Infant Pain Profile (PIPP)

Study Sites (1)

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