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Crochet Octopus in The Process of Heel Lance in Neonates

Primary Purpose

Procedural Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

crochet octopus

About this trial

This is an interventional supportive care trial for Procedural Pain focused on measuring neonate, pain, heel lance, developmental care

Eligibility Criteria

5 Days - 15 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Giresun University Women and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of Crying

Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus.

Full Information

NCT ID

NCT04560374

First Posted

September 13, 2020

Last Updated

April 27, 2021

Sponsor

Marmara University

1. Study Identification

Unique Protocol Identification Number

NCT04560374

Brief Title

Crochet Octopus in The Process of Heel Lance in Neonates

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

August 15, 2020 (Actual)

Study Completion Date

August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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".

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Procedural Pain

Keywords

neonate, pain, heel lance, developmental care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

crochet octopus

Intervention Description

Delivering crochet octopus to the hands of the neonates

Primary Outcome Measure Information:

Title

Neonate Infant Pain Scale Score

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Duration of Crying

Description

Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Days

Maximum Age & Unit of Time

15 Days

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cagri Covener Ozcelik, PhD

Organizational Affiliation

Marmara University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Özge Eren, MSN

Organizational Affiliation

Marmara University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nagihan Sabaz, MSN

Organizational Affiliation

Marmara University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Muhammet Bulut, MD

Organizational Affiliation

Giresun University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Giresun University Women and Children's Hospital

City

Giresun

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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Crochet Octopus in The Process of Heel Lance in Neonates

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