Non-Pharmacological Nursing Pain Management for Preterm Infants

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05947877

Enrollment

105

Registered

2023-07-17

Start date

2023-01-02

Completion date

2023-02-28

Last updated

2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management

Keywords

Non-pharmacological Pain Management Strategies, Preterm Infants, NICU

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.

Interventions

PROCEDURENon-pharmacological pain management strategies

Non-pharmacological pain management strategies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

32 Weeks to 37 Weeks

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026