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Clinical Trials/NCT05947877
NCT05947877
Completed
Not Applicable

Effectiveness of Interventional Non-Pharmacological Nursing Pain Management for Preterm Infants at Neonatal Intensive Care Unit

University of Baghdad1 site in 1 country105 target enrollmentJanuary 2, 2023
ConditionsPain Management

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain Management
Sponsor
University of Baghdad
Enrollment
105
Locations
1
Primary Endpoint
Premature Infant Pain Profile - Revised
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

A randomized controlled trial will be conducted to examine the effect of non-pharmacological nursing pain management strategies in alleviating pain among preterm infants. The study includes a simple random sample of 105 preterm infants with CGA 32- < 37 weeks were randomly assigned into five groups: routine care (n = 21), breast milk (n = 21), oral sucrose (n = 21), KMC (n = 21), nesting position (n = 21). PIPP-R will be used to subjectively assess the pain intensity after heel stick, and salivary cortisol measures will be used to objectively assess the pain intensity in NICU at Children Welfare Teaching Hospital/ Medical City Complex in Baghdad City.

Registry
clinicaltrials.gov
Start Date
January 2, 2023
End Date
February 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hiba Abdulwahid Dawood

Principal Investigator

University of Baghdad

Eligibility Criteria

Inclusion Criteria

  • Preterm infants whose corrected gestational age from (32 - \<37) weeks of pregnancy,
  • Preterm infants who do not experience any painful procedure for last 24 hours.
  • Preterm infants who do not receive any sedation for last 24 hours, and clinically required heel stick.

Exclusion Criteria

  • Full-term infants whose gestational age (GA) is \>37 weeks
  • Preterm infants who extremely preterm (\< 28 weeks); very preterm (28-\< 32 weeks)
  • Preterm infants who are proven or suspected sepsis, major congenital malformations, heart defect, necrotizing enterocolitis (NEC), and neurodevelopmental disability.
  • Preterm infants who receive respiratory support {Mechanical Ventilation, Continuous Positive Airway Pressure (CPAP), or high-flow support}
  • Preterm infants who are indicated for surgery
  • Preterm infants who are contraindicated to oral sucrose
  • Preterm infants who had a condition that might influence their physiological and responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.

Outcomes

Primary Outcomes

Premature Infant Pain Profile - Revised

Time Frame: Two months

Premature Infant Pain Profile - Revised measures pain intensity through infant indicators (heart rate, oxygen saturation, brow bulge, eye squeeze). Other indicators in the PIPP-R include gestational age and behavioral state.

Study Sites (1)

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