Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-30
SponsorMansoura University

About this trial

Neonates, particularly those hospitalized in neonatal intensive care units (NICUs), are subjected to numerous painful procedures essential for their diagnosis and monitoring. Heel lance, performed for routine blood sampling, stands as one of the most frequently encountered painful experiences for these vulnerable infants, as robust neurobiological evidence confirms that even preterm infants possess the anatomical and functional capacity to perceive pain, manifesting measurable physiological, hormonal, and behavioral responses. The daily average of acute painful events can reach up to 10-15 procedures in the NICU, and repeated exposure to inadequately managed procedural pain has been associated with immediate physiological instability as well as longer-term alterations in stress regulation, somatosensory processing, and neurodevelopmental outcomes. These vulnerabilities are further compounded in preterm and low birth weight infants who require prolonged hospitalization and specialized care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preterm neonates: Gestational age 32-37 weeks

Age: 2-30 days postnatal

Clinically stable

Requiring heel lance for routine blood sampling

Disqualifiers

Major congenital anomalies

Neurological disorders

Received pharmacological analgesia within 24 hours prior to the procedure

Receiving mechanical ventilation or continuous positive airway pressure (CPAP)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Crochet Octopus

    Device

    1. A standard crochet octopus will be placed with the neonate 10 minutes before the heel lance procedure. 2. The octopus will be positioned so that the neonate can touch its tendrils. 3. The octopus will remain with the neonate during the heel lance procedure. 4. The octopus will remain with the neonate for 10 minutes after the procedure completion. 5. Standard nursing care will be provided as per unit protocol. Crochet Octopus Specifications: * Handmade using 100% cotton yarn * Soft, with 8 curled tendrils approximately 15-20 cm in length * Hypoallergenic materials * Washable and sterilizable * Standard design consistent with published protocols

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Intervention Group (Crochet Octopus)Experimental treatment 1 intervention
Group B: Control Group (Standard Care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Neonatal Pain

The Premature Infant Pain Profile (PIPP) will be used to assess pain in preterm neonates (gestational age 32-36 weeks).

Time frame
through study completion, an average of 3 months
2

Behavioral State

The Brazelton Neonatal Behavioral Assessment Scale (NBAS) state categories will be used to classify the neonate's behavioral state

Time frame
through study completion, an average of 3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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