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Completed

NCT Number: NCT05947877

Non-Pharmacological Nursing Pain Management for Preterm Infants

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.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

32 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Nursing- The University of Baghdad

Baghdad, 14149, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-pharmacological pain management strategies

Procedure

Non-pharmacological pain management strategies

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Collaborators

  • Numan Nafie Hameed

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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