CompletedNot Applicable

Non-Pharmacological Nursing Pain Management for Preterm Infants

Iraq105 participantsStarted 2023-01-02

Plain-language 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.

Who can participate

Age range

32 Weeks – 37 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Premature Infant Pain Profile - Revised

Timeframe: Two months

Trial details

NCT IDNCT05947877

SponsorUniversity of Baghdad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-28

View on ClinicalTrials.gov More Pain Management trials