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

Effect of a Crochet Octopus in Reducing Procedural Pain and Improving Physiological and Behavioral Responses During Heel Lance in Preterm Neonates: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07828795
Acronym
RCT
Enrollment
98
Registered
2026-09-18
Start date
2026-10-01
Completion date
2027-09-01
Last updated
2026-09-18

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

Conditions

Heel Lance Procedures, Preterm Neonates, Procedural Pain

Keywords

Crochet Octopus, Procedural Pain, Heel Lance, Preterm Neonates

Brief summary

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.

Detailed description

While pharmacological analgesia is available, its use in neonates is often limited by concerns regarding dosing complexity, potential adverse effects, and safety in this vulnerable population. Consequently, non-pharmacological strategies have become central to neonatal pain management. Interventions such as kangaroo care (skin-to-skin contact), facilitated tucking, breastfeeding, sweet solutions, non-nutritive sucking, and various forms of auditory and tactile stimulation have consistently demonstrated effectiveness in reducing both behavioral and physiological indicators of pain. Breastfeeding has also been identified as the most effective method to reduce pain during heel lance in term newborns. Moreover, auditory interventions such as white noise and mother-sung lullabies have been shown to significantly reduce neonatal pain scores. These findings underscore the growing evidence base supporting non-pharmacological approaches. garnered attention as a simple, low-cost, and potentially effective tool for neonatal pain management. The crochet octopus is a soft, handmade toy with long, curled tendrils that neonates can grasp, providing tactile stimulation theorized to operate via the gate control theory of pain, whereby non-painful tactile input can close the "gates" to painful signals in the spinal cord. A seminal randomized controlled study by Çövener Özçelik et al. (2023), conducted with 100 term neonates, demonstrated that infants who touched a crochet octopus during heel lance had significantly higher oxygen saturation levels, shorter crying durations, and lower pain scores compared to the control group. More recently, Reddy et al. (2025) confirmed these findings in a randomized controlled trial involving 100 neonates, showing that octopus therapy significantly reduced pain scores, stabilized physiological parameters, and decreased crying duration during minor procedures. The intervention, where the octopus is provided 10 minutes before the procedure, has been shown to affect physiological measurements positively and reduce procedural pain.

Interventions

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

* Research assistants performing pain score assessments will be blinded to group allocation (video assessments will be conducted by assessors unaware of group assignment). * Parents cannot be blinded due to the nature of the intervention. * Nurses performing the heel lance cannot be blinded due to the visibility of the intervention. * Data analysts will be blinded to group allocation

Eligibility

Sex/Gender
ALL
Age
2 Days to 30 Days
Healthy volunteers
No

Inclusion criteria

* Preterm neonates: Gestational age 32-37 weeks * Age: 2-30 days postnatal * Clinically stable * Requiring heel lance for routine blood sampling

Exclusion criteria

* Major congenital anomalies * Neurological disorders * Received pharmacological analgesia within 24 hours prior to the procedure * Receiving mechanical ventilation or continuous positive airway pressure (CPAP)

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Painthrough study completion, an average of 3 monthsThe Premature Infant Pain Profile (PIPP) will be used to assess pain in preterm neonates (gestational age 32-36 weeks).
Behavioral Statethrough study completion, an average of 3 monthsThe Brazelton Neonatal Behavioral Assessment Scale (NBAS) state categories will be used to classify the neonate's behavioral state

Contacts

CONTACTSara Mustafa Hamza Taha, PhD
sarahamza@mans.edu.eg+20 01098022749

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026