Crochet Octopus in The Process of Heel Lance in Neonates

NCT04560374 | Completed Results

• 1 other identifier: 90139838-000-E.20252
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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".

Conditions

Procedural Pain

Keywords

neonate; pain; heel lance; developmental care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of Crying

  Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)

Study Arms (2)

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.

Device: crochet octopus

Control Group

NO INTERVENTION

Control group neonates were performed all the process without delivering them any crochet octopus.

Interventions

crochet octopus DEVICE

Delivering crochet octopus to the hands of the neonates

Experimental Group

Eligibility Criteria

• Age: 5 Days - 15 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Giresun University Women and Children's Hospital

Giresun, Turkey (Türkiye)

Location

Related Publications (44)

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MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Çağrı Çövener Özçelik
• Organization: Marmara University Faculty of Health Sciences Department of Pediatric Nursing

ccovener@gmail.com

009-0216-777-57-00

Study Officials

• Cagri Covener Ozcelik, PhD

  Marmara University

  STUDY CHAIR

• Özge Eren, MSN

  Marmara University

  PRINCIPAL INVESTIGATOR

• Nagihan Sabaz, MSN

  Marmara University

  PRINCIPAL INVESTIGATOR

• Muhammet Bulut, MD

  Giresun University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 23, 2020
• Study Start: May 1, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)