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Non-Pharmacological Nursing Pain Management for Preterm Infants

Not Applicable
Completed
Conditions
Pain Management
Registration Number
NCT05947877
Lead Sponsor
University of Baghdad
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
105
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
  • Twins
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Premature Infant Pain Profile - RevisedTwo 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

College of Nursing- The University of Baghdad

🇮🇶

Baghdad, Iraq

College of Nursing- The University of Baghdad
🇮🇶Baghdad, Iraq

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