Crochet Octopus in The Process of Heel Lance in Neonates

Study Overview
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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.

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.

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

Conditions
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Procedural Pain

Intervention / Treatment
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* Device: crochet octopus


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

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 15 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* Delivering crochet octopus to the hands of the neonates<br>|
| No Intervention: Control Group<br>Control group neonates were performed all the process without delivering them any crochet octopus. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Crying | Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus. | Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, pain, heel lance, developmental care