Reducing Pain During Heel Blood Collection in Preterm Newborns

Preterm Birth Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431452
• Other study ID #: 206337
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: Suleyman Demirel University
• Contact: Serife Tutar
• Phone: +905053126429
• Email: serifeguven[@]sdu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Days to 5 Days

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Premature Birth
• Preterm Birth

Intervention

Other:
• Pain management
Nonpharmacological pain management during blood collection in preterm infants

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain management	Management of pain heel puncture in premature newborn. The parameter for pain management will be determined by the Premature Infant Pain Profile (PIPP)	10 month