Non-Pharmacological Nursing Pain Management for Preterm Infants

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05947877
• Other study ID #: Preterm Infant Pain Management
• Status: Completed
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management
• Premature Birth

Intervention

Procedure:
• Non-pharmacological pain management strategies
Non-pharmacological pain management strategies

Locations

Country	Name	City	State
Iraq	College of Nursing- The University of Baghdad	Baghdad

Sponsors (2)

Lead Sponsor	Collaborator
University of Baghdad	Numan Nafie Hameed

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature Infant Pain Profile - Revised	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.	Two months