Non-Pharmacological Nursing Pain Management for Preterm Infants

Sponsor

University of Baghdad (Other)

Overall Status

Completed

CT.gov ID

NCT05947877

Collaborator

Numan Nafie Hameed (Other)

105

Enrollment

Location

Arms

1.9

Actual Duration (Months)

56.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Management	Procedure: Non-pharmacological pain management strategies	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Preterm infants and their mothers were masked from the nature of the administered intervention.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 2, 2023

Actual Primary Completion Date :

Feb 28, 2023

Actual Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-pharmacological nursing pain management strategies This arm considers conventional care.	Procedure: Non-pharmacological pain management strategies Non-pharmacological pain management strategies
Experimental: Breast milk This arm considers breast milk. The preterm infants were orally fed 2 ml of expressed breast milk through a syringe 2 minutes before heel stick over the anterior surface of the tongue, allowing for preterm infant swallowing rates over a period of 1-2 minutes. Thereafter, the bedside nurse conducts the heel lancing. When the mother is present with her preterm infant in the NICU, the breast milk was expressed by the mother and provided in a syringe at least 30 minutes before the intervention (n = 11). For the rest 10 preterm infants whose mothers were not present with them in the NICU, they send their breast milk to be kept in the NICU refrigerator. This milk was first warmed in room temperature 30 minutes before it was given to the preterm infant.	Procedure: Non-pharmacological pain management strategies Non-pharmacological pain management strategies
Experimental: Oral sucrose This arm considers oral sucrose. The researchers gave one ml of 24% oral sucrose to the preterm infant two minutes prior to the heel stick, drop-by-drop via syringe over the anterior surface of the tongue which enable the preterm infant to swallow rates over a period of 1-2 minutes. Conducting the heel stick procedure with lancet approximately two minutes after administering the sucrose. The pharmacy at the study site supplies the syringes containing the oral sucrose solution, solutions are prepared and packaged in an identical matter, the SR will label each syringe with the preterm infants' study number and name to ensure added protection.	Procedure: Non-pharmacological pain management strategies Non-pharmacological pain management strategies
Experimental: KMC This arm considers KMC. The preterm infants were randomized to the KMC intervention; the researchers explained to the mother that she and her preterm infants will be put in KMC position, where the diaper-clad infant was held upright, at an angle of approximately 60°, between the mothers' breasts, providing maximal skin-to-skin contact between mother and baby. A blanket was placed over the preterm infant's back, and the mother's clothes were wrapped around the neonate, the preterm infant will remain in KMC for 30 minutes before the lancing procedure, during, and at least 30 minutes after the heel lance.	Procedure: Non-pharmacological pain management strategies Non-pharmacological pain management strategies
Experimental: Nesting position This arm considers nesting position. Before heel lancing, the researchers prepared and arranged all the required nesting equipment from the NICU such as linen, small pillow, and blanket. Making the nest by folding the blanket form one corner, then placing it upright and laying the linen over the blanket. Positioning the preterm infant inside the nest in supine position, ensuring that the nest size is suitable for the preterm infant's body, neither too loose nor too tight during nesting position. Position the preterm infant first in supine position through wrapping infant with hand to midline the nest through putting small pillow under the preterm infant's shoulder to keep airway open, the nested infants were placed in nest, that helped to maintain and support them in a flexed position but still facilitated unrestricted movement of their body and limbs, supine nesting position conducting 30 minutes before heel lancing and, during, and after the procedure for 30 minutes.	Procedure: Non-pharmacological pain management strategies Non-pharmacological pain management strategies

Outcome Measures

Primary Outcome Measures

Premature Infant Pain Profile - Revised [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Nursing- The University of Baghdad	Baghdad		Iraq	14149

Sponsors and Collaborators

University of Baghdad
Numan Nafie Hameed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hiba Abdulwahid Dawood, Principal Investigator, University of Baghdad

ClinicalTrials.gov Identifier:

NCT05947877

Other Study ID Numbers:

Preterm Infant Pain Management

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hiba Abdulwahid Dawood, Principal Investigator, University of Baghdad

Non-pharmacological Pain Management Strategies

Preterm Infants

NICU

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jul 17, 2023