Crochet Octopus in The Process of Heel Lance in Neonates
NCT ID: NCT04560374
Last Updated: 2021-05-18
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-05-01
Study Completion Date
2020-08-15
Brief Summary
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The main objective of the study was to determine the effect of using crochet octopus in order to reduce the acute pain developed during the process of heel lance in neonates.
The hypothesis of the study was "Crochet octopus is rather effective in reducing the acute pain in heel lance process for neonates".
The hypothesis of the study was "Crochet octopus is rather effective in reducing the acute pain in heel lance process for neonates".
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Detailed Description
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The study was conducted as randomized controlled. It included term neonates born between May 2020 and August 2020 at a training and research hospital. The study was completed with 100 neonates in total as 50 for experiment and 50 for control groups. During the process of heel lance, experiment group neonates were delivered crochet octopus 10 minutes before the process and let them touch the octopus 10 minutes more after the process. Control group neonates experienced the process without any intervention. As for the data collection, "Newborn Identification Form", "Neonatal-Infant Pain Scale (NIPS)" and "Observation Form" were utilized. The whole process was video-recorded.
Conditions
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Procedural Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized controlled study
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Experimental Group
Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.
Group Type
EXPERIMENTAL
crochet octopus
Intervention Type
DEVICE
Delivering crochet octopus to the hands of the neonates
Control Group
Control group neonates were performed all the process without delivering them any crochet octopus.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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crochet octopus
Delivering crochet octopus to the hands of the neonates
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* being a healthy term neonates,
* being 5-15 days,
* taking of blood sample for Guthrie test routinely.
* being 5-15 days,
* taking of blood sample for Guthrie test routinely.
Exclusion Criteria
* admitted to the neonatal intensive care units
* his/her being taken any analgesics prior to the intervention,
* having any congenital anomalies
* his/her being taken any analgesics prior to the intervention,
* having any congenital anomalies
Minimum Eligible Age
5 Days
Maximum Eligible Age
15 Days
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Marmara University
OTHER
Sponsor Role
lead
Responsible Party
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cagri covener ozcelik
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Cagri Covener Ozcelik, PhD
Role: STUDY_CHAIR
Marmara University
Özge Eren, MSN
Role: PRINCIPAL_INVESTIGATOR
Marmara University
Nagihan Sabaz, MSN
Role: PRINCIPAL_INVESTIGATOR
Marmara University
Muhammet Bulut, MD
Role: PRINCIPAL_INVESTIGATOR
Giresun University
Locations
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Giresun University Women and Children's Hospital
Giresun, , Turkey (Türkiye)
Site Status
Countries
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Turkey (Türkiye)
References
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Abbasoglu A, Cabioglu MT, Tugcu AU, Ince DA, Tekindal MA, Ecevit A, Tarcan A. Acupressure at BL60 and K3 Points Before Heel Lancing in Preterm Infants. Explore (NY). 2015 Sep-Oct;11(5):363-6. doi: 10.1016/j.explore.2015.07.005. Epub 2015 Jul 3.
Reference Type
BACKGROUND
Akcan E, Polat S. Comparative Effect of the Smells of Amniotic Fluid, Breast Milk, and Lavender on Newborns' Pain During Heel Lance. Breastfeed Med. 2016 Aug;11(6):309-314. doi: 10.1089/bfm.2015.0174. Epub 2016 Jun 17.
Reference Type
BACKGROUND
American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
Reference Type
BACKGROUND
Anand KJ; International Evidence-Based Group for Neonatal Pain. Consensus statement for the prevention and management of pain in the newborn. Arch Pediatr Adolesc Med. 2001 Feb;155(2):173-80. doi: 10.1001/archpedi.155.2.173.
Reference Type
BACKGROUND
Asmerom Y, Slater L, Boskovic DS, Bahjri K, Holden MS, Phillips R, Deming D, Ashwal S, Fayard E, Angeles DM. Oral sucrose for heel lance increases adenosine triphosphate use and oxidative stress in preterm neonates. J Pediatr. 2013 Jul;163(1):29-35.e1. doi: 10.1016/j.jpeds.2012.12.088. Epub 2013 Feb 14.
Reference Type
BACKGROUND
Axelin A, Salantera S, Lehtonen L. 'Facilitated tucking by parents' in pain management of preterm infants-a randomized crossover trial. Early Hum Dev. 2006 Apr;82(4):241-7. doi: 10.1016/j.earlhumdev.2005.09.012. Epub 2006 Jan 10.
Reference Type
BACKGROUND
Bueno M, Stevens B, de Camargo PP, Toma E, Krebs VL, Kimura AF. Breast milk and glucose for pain relief in preterm infants: a noninferiority randomized controlled trial. Pediatrics. 2012 Apr;129(4):664-70. doi: 10.1542/peds.2011-2024. Epub 2012 Mar 5.
Reference Type
BACKGROUND
Courtois E, Droutman S, Magny JF, Merchaoui Z, Durrmeyer X, Roussel C, Biran V, Eleni S, Vottier G, Renolleau S, Desfrere L, Castela F, Boimond N, Mellah D, Bolot P, Coursol A, Brault D, Chappuy H, Cimerman P, Anand KJ, Carbajal R. Epidemiology and neonatal pain management of heelsticks in intensive care units: EPIPPAIN 2, a prospective observational study. Int J Nurs Stud. 2016 Jul;59:79-88. doi: 10.1016/j.ijnurstu.2016.03.014. Epub 2016 Mar 30.
Reference Type
BACKGROUND
Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics. 2000 Jan;105(1):e14. doi: 10.1542/peds.105.1.e14.
Reference Type
BACKGROUND
Grunau RE. Neonatal pain in very preterm infants: long-term effects on brain, neurodevelopment and pain reactivity. Rambam Maimonides Med J. 2013 Oct 29;4(4):e0025. doi: 10.5041/RMMJ.10132. eCollection 2013.
Reference Type
BACKGROUND
Hebb AL, Poulin JF, Roach SP, Zacharko RM, Drolet G. Cholecystokinin and endogenous opioid peptides: interactive influence on pain, cognition, and emotion. Prog Neuropsychopharmacol Biol Psychiatry. 2005 Dec;29(8):1225-38. doi: 10.1016/j.pnpbp.2005.08.008. Epub 2005 Oct 20.
Reference Type
BACKGROUND
Mangat AK, Oei JL, Chen K, Quah-Smith I, Schmolzer GM. A Review of Non-Pharmacological Treatments for Pain Management in Newborn Infants. Children (Basel). 2018 Sep 20;5(10):130. doi: 10.3390/children5100130.
Reference Type
BACKGROUND
Hill S, Engle S, Jorgensen J, Kralik A, Whitman K. Effects of facilitated tucking during routine care of infants born preterm. Pediatr Phys Ther. 2005 Summer;17(2):158-63. doi: 10.1097/01.pep.0000163097.38957.ec.
Reference Type
BACKGROUND
Huang CM, Tung WS, Kuo LL, Ying-Ju C. Comparison of pain responses of premature infants to the heelstick between containment and swaddling. J Nurs Res. 2004 Mar;12(1):31-40. doi: 10.1097/01.jnr.0000387486.78685.c5.
Reference Type
BACKGROUND
Hall RW, Anand KJ. Pain management in newborns. Clin Perinatol. 2014 Dec;41(4):895-924. doi: 10.1016/j.clp.2014.08.010. Epub 2014 Oct 7.
Reference Type
BACKGROUND
Hwang MJ, Seol GH. Cerebral Oxygenation and Pain of Heel Blood Sampling Using Manual and Automatic Lancets in Premature Infants. J Perinat Neonatal Nurs. 2015 Oct-Dec;29(4):356-62. doi: 10.1097/JPN.0000000000000138.
Reference Type
BACKGROUND
Jain S, Kumar P, McMillan DD. Prior leg massage decreases pain responses to heel stick in preterm babies. J Paediatr Child Health. 2006 Sep;42(9):505-8. doi: 10.1111/j.1440-1754.2006.00912.x.
Reference Type
BACKGROUND
Johnson AN. Kangaroo holding beyond the NICU. Pediatr Nurs. 2005 Jan-Feb;31(1):53-6.
Reference Type
BACKGROUND
Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Aita M, Finley GA, Walker CD. Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. BMC Pediatr. 2008 Apr 24;8:13. doi: 10.1186/1471-2431-8-13.
Reference Type
BACKGROUND
Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.
Reference Type
BACKGROUND
Johnston C, Campbell-Yeo M, Fernandes A, Inglis D, Streiner D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2014 Jan 23;(1):CD008435. doi: 10.1002/14651858.CD008435.pub2.
Reference Type
BACKGROUND
Kahraman A, Basbakkal Z, Yalaz M, Sozmen EY. The effect of nesting positions on pain, stress and comfort during heel lance in premature infants. Pediatr Neonatol. 2018 Aug;59(4):352-359. doi: 10.1016/j.pedneo.2017.11.010. Epub 2017 Nov 13.
Reference Type
BACKGROUND
Kostandy RR, Ludington-Hoe SM, Cong X, Abouelfettoh A, Bronson C, Stankus A, Jarrell JR. Kangaroo Care (skin contact) reduces crying response to pain in preterm neonates: pilot results. Pain Manag Nurs. 2008 Jun;9(2):55-65. doi: 10.1016/j.pmn.2007.11.004.
Reference Type
BACKGROUND
Kucukoglu S, Kurt S, Aytekin A. The effect of the facilitated tucking position in reducing vaccination-induced pain in newborns. Ital J Pediatr. 2015 Aug 21;41:61. doi: 10.1186/s13052-015-0168-9.
Reference Type
BACKGROUND
Liu M, Zhao L, Li XF. Effect of skin contact between mother and child in pain relief of full-term newborns during heel blood collection. Clin Exp Obstet Gynecol. 2015;42(3):304-8.
Reference Type
BACKGROUND
Livingston K, Beider S, Kant AJ, Gallardo CC, Joseph MH, Gold JI. Touch and massage for medically fragile infants. Evid Based Complement Alternat Med. 2009 Dec;6(4):473-82. doi: 10.1093/ecam/nem076. Epub 2007 Aug 6.
Reference Type
BACKGROUND
Losacco V, Cuttini M, Greisen G, Haumont D, Pallas-Alonso CR, Pierrat V, Warren I, Smit BJ, Westrup B, Sizun J; ESF Network. Heel blood sampling in European neonatal intensive care units: compliance with pain management guidelines. Arch Dis Child Fetal Neonatal Ed. 2011 Jan;96(1):F65-8. doi: 10.1136/adc.2010.186429.
Reference Type
BACKGROUND
Meek J, Huertas A. Cochrane review: Non-nutritive sucking, kangaroo care and swaddling/facilitated tucking are observed to reduce procedural pain in infants and young children. Evid Based Nurs. 2012 Jul;15(3):84-5. doi: 10.1136/ebnurs-2011-100453. Epub 2012 Mar 12. No abstract available.
Reference Type
BACKGROUND
Morrow C, Hidinger A, Wilkinson-Faulk D. Reducing neonatal pain during routine heel lance procedures. MCN Am J Matern Child Nurs. 2010 Nov-Dec;35(6):346-54; quiz 354-6. doi: 10.1097/NMC.0b013e3181f4fc53.
Reference Type
BACKGROUND
Perry M, Tan Z, Chen J, Weidig T, Xu W, Cong XS. Neonatal Pain: Perceptions and Current Practice. Crit Care Nurs Clin North Am. 2018 Dec;30(4):549-561. doi: 10.1016/j.cnc.2018.07.013.
Reference Type
BACKGROUND
Pillai Riddell RR, Racine NM, Turcotte K, Uman LS, Horton RE, Din Osmun L, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Gerwitz-Stern A. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006275. doi: 10.1002/14651858.CD006275.pub2.
Reference Type
BACKGROUND
Shah SR, Kadage S, Sinn J. Trial of Music, Sucrose, and Combination Therapy for Pain Relief during Heel Prick Procedures in Neonates. J Pediatr. 2017 Nov;190:153-158.e2. doi: 10.1016/j.jpeds.2017.08.003.
Reference Type
BACKGROUND
Smith A, Tamgumus S, Lawless S, Penrose P, EL-Khuffash A, Boyle MA. Tentacles For Tinies: The Many Arms of the Crocheted Octopus. Ir Med J. 2018 Sep 10;111(8):812. No abstract available.
Reference Type
BACKGROUND
Soltani S, Zohoori D, Adineh M. Comparison the Effectiveness of Breastfeeding, Oral 25% Dextrose, Kangaroo-Mother Care Method, and EMLA Cream on Pain Score Level Following Heal Pick Sampling in Newborns: a randomized clinical trial. Electron Physician. 2018 May 5;10(5):6741-6748. doi: 10.19082/6741. eCollection 2018 May.
Reference Type
BACKGROUND
Stevens B, Gibbins S, Franck LS. Treatment of pain in the neonatal intensive care unit. Pediatr Clin North Am. 2000 Jun;47(3):633-50. doi: 10.1016/s0031-3955(05)70230-3.
Reference Type
BACKGROUND
Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.
Reference Type
BACKGROUND
Stevens B, Yamada J, Campbell-Yeo M, Gibbins S, Harrison D, Dionne K, Taddio A, McNair C, Willan A, Ballantyne M, Widger K, Sidani S, Estabrooks C, Synnes A, Squires J, Victor C, Riahi S. The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial. BMC Pediatr. 2018 Feb 23;18(1):85. doi: 10.1186/s12887-018-1026-x.
Reference Type
BACKGROUND
Taddio A, Katz J. The effects of early pain experience in neonates on pain responses in infancy and childhood. Paediatr Drugs. 2005;7(4):245-57. doi: 10.2165/00148581-200507040-00004.
Reference Type
BACKGROUND
van Sleuwen BE, L'hoir MP, Engelberts AC, Busschers WB, Westers P, Blom MA, Schulpen TW, Kuis W. Comparison of behavior modification with and without swaddling as interventions for excessive crying. J Pediatr. 2006 Oct;149(4):512-7. doi: 10.1016/j.jpeds.2006.06.068.
Reference Type
BACKGROUND
Whitfield MF, Grunau RE. Behavior, pain perception, and the extremely low-birth weight survivor. Clin Perinatol. 2000 Jun;27(2):363-79. doi: 10.1016/s0095-5108(05)70026-9.
Reference Type
BACKGROUND
Zargham-Boroujeni A, Elsagh A, Mohammadizadeh M. The Effects of Massage and Breastfeeding on Response to Venipuncture Pain among Hospitalized Neonates. Iran J Nurs Midwifery Res. 2017 Jul-Aug;22(4):308-312. doi: 10.4103/ijnmr.IJNMR_119_13.
Reference Type
BACKGROUND
Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.
Reference Type
RESULT
Cong X, Ludington-Hoe SM, McCain G, Fu P. Kangaroo Care modifies preterm infant heart rate variability in response to heel stick pain: pilot study. Early Hum Dev. 2009 Sep;85(9):561-7. doi: 10.1016/j.earlhumdev.2009.05.012. Epub 2009 Jun 7.
Reference Type
RESULT
Erkut Z, Yildiz S. The Effect of Swaddling on Pain, Vital Signs, and Crying Duration during Heel Lance in Newborns. Pain Manag Nurs. 2017 Oct;18(5):328-336. doi: 10.1016/j.pmn.2017.05.007. Epub 2017 Aug 2.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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90139838-000-E.20252
Identifier Type: -
Identifier Source: org_study_id
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