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Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates (RCT)
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
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Sara Mustafa Hamza Taha, PhD
- Telefoonnummer: +20 01098022749
- E-mail: sarahamza@mans.edu.eg
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention Group (Crochet Octopus)
Intervention Group (Crochet Octopus) |
Crochet Octopus Specifications:
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Geen tussenkomst: Control Group (Standard Care)
Control Group (Standard Care) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Neonatal Pain
Tijdsspanne: through study completion, an average of 3 months
|
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
Tijdsspanne: through study completion, an average of 3 months
|
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
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SS.26.08.40
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data (IPD) will not be shared publicly because the dataset contains potentially identifiable participant information. Sharing the raw data could compromise participants' privacy and confidentiality. Therefore, IPD will not be made publicly available. However, anonymized or aggregated data may be considered for sharing upon reasonable request, subject to ethical approval, institutional policies, and applicable data-protection regulations.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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