Preterm NeonatesRCTNCT07828795
Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates
A study testing Crochet Octopus in people with Preterm Neonates and Heel Lance Procedures, run by Mansoura University.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 30 days
- Conditions the study is for
- Preterm Neonates, Heel Lance Procedures, Procedural Pain
- What is being tested?
- Crochet Octopus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Neonates, Heel Lance Procedures, Procedural Pain
- Being tested
- Crochet Octopus
- Keywords
- Crochet Octopus, Procedural Pain, Heel Lance, Preterm Neonates
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crochet OctopusDevice
- A standard crochet octopus will be placed with the neonate 10 minutes before the heel lance procedure.
- The octopus will be positioned so that the neonate can touch its tendrils.
- The octopus will remain with the neonate during the heel lance procedure.
- The octopus will remain with the neonate for 10 minutes after the procedure completion.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Crochet Octopus) | Experimental | Intervention Group (Crochet Octopus) Receives: Device: Crochet Octopus |
| Control Group (Standard Care) | No intervention | Control Group (Standard Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Pain
The Premature Infant Pain Profile (PIPP) will be used to assess pain in preterm neonates (gestational age 32-36 weeks).
Measured: 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
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mustafa Hamza Taha, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828795
- Sponsor's protocol ID
- SS.26.08.40
- Acronym
- RCT
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40075464Covener 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.
PubMed 36525534Bastons-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.
PubMed 28890146