An interventional study of Non-pharmacological pain management strategies in Pain Management, sponsored by University of Baghdad. Completed at 1 site in Iraq. Open to participants aged 32 Weeks to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by University of Baghdad · Not applicable, Interventional, and Supportive care
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 105 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
This arm considers conventional care.
Procedure: Non-pharmacological pain management strategies
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
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
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
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
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.
Time frame: Two months
Plan to share: Undecided
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of Baghdad