Procedural PainNCT04560374

Crochet Octopus in The Process of Heel Lance in Neonates

A study testing crochet octopus in people with Procedural Pain, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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". Read more about this study

Who is it for?: Ages 5 to 15 daysHealthy volunteers can take part
Conditions the study is for: 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: 100 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 May 2020to 15 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 to 15 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

being a healthy term neonates,
being 5-15 days,
taking of blood sample for Guthrie test routinely.

Who cannot join

admitted to the neonatal intensive care units
his/her being taken any analgesics prior to the intervention,
having any congenital anomalies

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Giresun University Women and Children's Hospital
Giresun

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Using Crochet Octopus in Reducing The Pain Developed During The Process of Heel Lance İn Neonates: A Randomized Controlled Study

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".

Read the detailed description

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: Procedural Pain
Being tested: crochet octopus
Keywords: neonate, pain, heel lance, developmental care
Medical subject headings: Pain, Procedural, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

crochet octopusDevice
Delivering crochet octopus to the hands of the neonates

Study groups in NCT04560374
Study group	Role	What they receive
Experimental Group	Experimental	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. Receives: Device: crochet octopus
Control Group	No intervention	Control group neonates were performed all the process without delivering them any crochet octopus.

What is being measured

The primary outcome is the main question the study is designed to answer.

Neonate Infant Pain Scale Score
Neonate Infant Pain Scale score calculated before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus. It is a 6-itemed scale developed to assess the pain occuring due to interventions implemented to term and premature infants. The scoring of the scale was realized by assessing five behavioral classification (mimics, crying, movements of arms and legs, wakefulness state) and one physological parameter (type of respiration). It needs too much time and is difficult to assess intubated infants. It is suitable for painful conditions of non-intubated infants . Total score calculated. The lowest score of the scale is 0; the highest one is 7 and 3+ score shows the presence of pain.
Measured: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)

Secondary outcomes (1)

Duration of Crying
Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus.
Measured: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202015 Aug 2020

First posted23 Sep 2020
Study start1 May 2020
Primary completion15 Aug 2020
Study completion15 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (44)Papers the sponsor has linked to this study.
Other trials for Procedural PainStudies of the same condition, open and under way.
More trials run by Marmara UniversityThe sponsor's other registered studies.
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
Model description: Randomized controlled study
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04560374
Sponsor's protocol ID: 90139838-000-E.20252
Status last verified: Apr 2021
First submitted: 13 Sep 2020
Last updated: 18 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26242287
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.
PubMed 27315487
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.
PubMed 17079598
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.
PubMed 11177093
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.
PubMed 23415615
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.
PubMed 16410042
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.
PubMed 22392169
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.
PubMed 27222453
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.
PubMed 10617751
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.
PubMed 24228168
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.
PubMed 16242828
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.
PubMed 30241352
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.
PubMed 16357666
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.
PubMed 15136961
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.
PubMed 25459780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Procedural Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Using Crochet Octopus in Reducing The Pain Developed During The Process of Heel Lance İn Neonates: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT04560374
Acronym / sponsor ID: 90139838-000-E.20252
Conditions: Procedural Pain
Keywords: neonate, pain, heel lance, developmental care
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Marmara UniversityUniversity, hospital or other
Study start: 1 May 2020 (actual)
Primary completion: 15 Aug 2020 (actual)
Study completion: 15 Aug 2020 (actual)
First posted: 23 Sep 2020 (actual)
Results: Posted 18 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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".

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized controlled study

Arm	Type	Receives
Experimental Group	Experimental	Device: crochet octopusCrochet 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.
Control Group	No intervention	–Control group neonates were performed all the process without delivering them any crochet octopus.

Who may qualify

Ages: 5 to 15 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

being a healthy term neonates,
being 5-15 days,
taking of blood sample for Guthrie test routinely.

Key exclusion criteria (3 listed)

admitted to the neonatal intensive care units
his/her being taken any analgesics prior to the intervention,
having any congenital anomalies

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
crochet octopusDelivering crochet octopus to the hands of the neonates	Device	Experimental Group

Primary outcome

Neonate Infant Pain Scale Score
Time frame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)
Neonate Infant Pain Scale score calculated before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus. It is a 6-itemed scale developed to assess the pain occuring due to interventions implemented to term and premature infants. The scoring of the scale was realized by assessing five behavioral classification (mimics, crying, movements of arms and legs, wakefulness state) and one physological parameter (type of respiration). It needs too much time and is difficult to assess intubated infants. It is suitable for painful conditions of non-intubated infants . Total score calculated. The lowest score of the scale is 0; the highest one is 7 and 3+ score shows the presence of pain.

1 secondary outcome

Duration of Crying
Time frame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	50	50
Control Group	50	50

Primary outcome: Neonate Infant Pain Scale Score

Time frame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Experimental Group n = 50	Control Group n = 50
Before procedure (0th min.)	0 (0 to 1)	1 (0 to 1)
During procedure	4 (3 to 5)	4 (3 to 5)
After procedure (2nd min)	0 (0 to 1.25)	2 (1 to 3)
After procedure (10th min)	0 (0 to 0)	1 (0 to 1)

Experimental Group vs Control Group: p <0.001, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: No adverse event data were collected. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	0 of 0	0 of 0	0
Control Group	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26242287Abbasoglu 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.
Background: PubMed 27315487Akcan 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.
Background: PubMed 17079598American 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.
Background: PubMed 11177093Anand 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.
Background: PubMed 23415615Asmerom 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.
Background: PubMed 16410042Axelin 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.
Background: PubMed 22392169Bueno 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.
Background: PubMed 27222453Courtois 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.
Background: PubMed 10617751Gray 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.
Background: PubMed 24228168Grunau 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.
Background: PubMed 16242828Hebb 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.
Background: PubMed 30241352Mangat 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cagri Covener Ozcelik, PhD study chair

Marmara University

Özge Eren, MSN principal investigator

Marmara University

Nagihan Sabaz, MSN principal investigator

Marmara University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing crochet octopus in people with Procedural Pain, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonate Infant Pain Scale Score (time frame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560374, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.