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Crochet Octopus in The Process of Heel Lance in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560374
Recruitment Status : Completed
First Posted : September 23, 2020
Results First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
cagri covener ozcelik, Marmara University

Study Description
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Brief 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".


Condition or disease Intervention/treatment Phase
Procedural Pain Device: crochet octopus Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled study
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : August 15, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: crochet octopus
Delivering crochet octopus to the hands of the neonates
No Intervention: Control Group
Control group neonates were performed all the process without delivering them any crochet octopus.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of Crying [ Time Frame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes) ]
    Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus.


Eligibility Criteria
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Ages Eligible for Study:   5 Days to 15 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • being a healthy term neonates,
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560374


Locations
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Turkey
Giresun University Women and Children's Hospital
Giresun, Turkey
Sponsors and Collaborators
Marmara University
Investigators
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Study Chair: Cagri Covener Ozcelik, PhD Marmara University
Principal Investigator: Özge Eren, MSN Marmara University
Principal Investigator: Nagihan Sabaz, MSN Marmara University
Principal Investigator: Muhammet Bulut, MD Giresun University
  Study Documents (Full-Text)

Documents provided by cagri covener ozcelik, Marmara University:
Study Protocol and Statistical Analysis Plan  [PDF] May 1, 2020

More Information
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Publications of Results:

Other Publications:

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Responsible Party: cagri covener ozcelik, Associate Professor, Marmara University
ClinicalTrials.gov Identifier: NCT04560374    
Other Study ID Numbers: 90139838-000-E.20252
First Posted: September 23, 2020    Key Record Dates
Results First Posted: May 18, 2021
Last Update Posted: May 18, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by cagri covener ozcelik, Marmara University:
neonate
pain
heel lance
developmental care
Additional relevant MeSH terms:
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Pain, Procedural
Pain
Neurologic Manifestations