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

NCT07828795 | Not Yet Recruiting

• 1 other identifier: SS.26.08.40
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Neonates; Procedural Pain; Heel Lance Procedures

Keywords

Crochet Octopus; Procedural Pain; Heel Lance; Preterm Neonates

Outcome Measures

Primary Outcomes (2)

• Neonatal Pain

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

  through study completion, an average of 3 months

• Behavioral State

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

  through study completion, an average of 3 months

Study Arms (2)

Intervention Group (Crochet Octopus)

EXPERIMENTAL

Intervention Group (Crochet Octopus)

Device: Crochet Octopus

Control Group (Standard Care)

NO INTERVENTION

Control Group (Standard Care)

Interventions

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

Intervention Group (Crochet Octopus)

Eligibility Criteria

• Age: 2 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates: Gestational age 32-37 weeks
• Age: 2-30 days postnatal
• Clinically stable

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (3)

• Karga Yilmaz T, Yavuz B. Comparison of different methods for reducing pain during a heel lance in newborns: a randomized trial. Ital J Pediatr. 2025 Mar 12;51(1):73. doi: 10.1186/s13052-025-01916-w.

  PMID: 40075464 RESULT

• Covener Ozcelik C, Eren O, Sabaz N, Bulut M. Effect of using crochet octopus in reducing the pain: a randomized controlled study. J Trop Pediatr. 2022 Dec 5;69(1):fmac107. doi: 10.1093/tropej/fmac107.

  PMID: 36525534 RESULT

• Bastons-Compta A, Astals M, Sanchez E, Garcia-Algar O. Knitted octopuses inside the incubators, a non-evidence based viral practice. Early Hum Dev. 2019 Jan;128:101. doi: 10.1016/j.earlhumdev.2017.09.001. Epub 2017 Sep 8. No abstract available.

  PMID: 28890146 RESULT

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Mustafa Hamza Taha, PhD

CONTACT

+20 01098022749; sarahamza@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of Pediatric Nursing, Pediatric Nursing Department, Faculty of Nursing, Mansoura University

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share