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Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation

Primary Purpose

Catheterization, Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Trace Image and Coloring for Kids-Book (TICK-B)
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheterization

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric patients 6-12 years old,
  • Pediatric who needed peripheral cannulation,

Exclusion Criteria:

  • Children with chronic conditions,
  • impairments physical,
  • Disabilities with communicating difficulties,
  • Those whose parent not participated,
  • Neurodevelopmental delayed, can't verbal speak, hearing or visual impairments,
  • Children with coma or drowsiness,
  • have to take analgesic medication for less than 6 hrs.
  • history of syncope.

Sites / Locations

  • Sherzad Suleman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TICK-B group as Intervention group

Standard care provided group as control group

Arm Description

Pediatric patients received TICK-B as a distraction in the TICK-B group Trace Image and Coloring for Kids-Book were conducted on the children undergoing the Cannulation procedure.

Pediatric patients received standard care (routine care) in the control group.

Outcomes

Primary Outcome Measures

Self-reported pain
Pain: The severity of pain measured by Faces Pain Scale-Revised (FPS-R): The FPS-R ranking is a 0-10 scale with the six cartoons.

Secondary Outcome Measures

Fear Measure
The Childrens Fear Scale (CFS) is used to assess children's fear or anxiety levels. The one-item scale consists of five sex-neutral faces arranged from left to right with no fear in the center, through fear out to extreme fear.

Full Information

First Posted
January 13, 2021
Last Updated
March 26, 2021
Sponsor
University of Witten/Herdecke
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1. Study Identification

Unique Protocol Identification Number
NCT04714255
Brief Title
Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
Official Title
The Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 3, 2019 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Peripheral Intravenous Cannulation (PIVC), one of the most common therapeutic procedures in medical care, can be difficult even for experienced medical practitioners. The pain of intravenous cannulation is considered the major limitation in pediatric clinical care. Reducing the pain of intravenous cannulation has been the motive for many investigations. Intervention methods used to reduce the distress related to painful procedures are widely recommended. The management of pain and anxiety is more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture-related pain and distress, with strong evidence supporting its efficacy in children. Art therapy commonly used to reduce pain and anxiety of children's disease but was not used in reducing distress outcomes of painful procedures. We used a collection of the image need for coloring and tracing called Trace Image and Coloring for Kids-Book (TICK-B). The purpose of this study is to exam the effectiveness of TICK-B in decreasing pain and anxiety during cannulation.
Detailed Description
Peripheral Intravenous Cannulation (PIVC), one of the most common therapeutic procedures in medical care, can be difficult even for experienced medical practitioners. The pain of intravenous cannulation is considered the major limitation in pediatric clinical care. Reducing the pain of intravenous cannulation has been the motive for many investigations. Intervention methods used to reduce the distress related to painful procedures are widely recommended. The management of pain and anxiety is more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture-related pain and distress, with strong evidence supporting its efficacy in children. Art therapy commonly used to reduce pain and anxiety of children's disease but was not used in reducing distress outcomes of painful procedures. We used a collection of the image need for coloring and tracing called Trace Image and Coloring for Kids-Book (TICK-B). The purpose of this study is to exam the effectiveness of TICK-B in decreasing pain and anxiety during cannulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheterization, Pain, Anxiety, Art, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TICK-B group as Intervention group
Arm Type
Experimental
Arm Description
Pediatric patients received TICK-B as a distraction in the TICK-B group Trace Image and Coloring for Kids-Book were conducted on the children undergoing the Cannulation procedure.
Arm Title
Standard care provided group as control group
Arm Type
No Intervention
Arm Description
Pediatric patients received standard care (routine care) in the control group.
Intervention Type
Other
Intervention Name(s)
Trace Image and Coloring for Kids-Book (TICK-B)
Intervention Description
A collection of images attractive that need to be colored, created as a book called TICK-B. This book was created with the instructions and recommendations of a pediatric psychiatrist and a professional drawing teacher at a children's school.Distraction with TICK-B began 1-3 min. before the intravenous cannula procedure and lasted until the end of the procedure.
Primary Outcome Measure Information:
Title
Self-reported pain
Description
Pain: The severity of pain measured by Faces Pain Scale-Revised (FPS-R): The FPS-R ranking is a 0-10 scale with the six cartoons.
Time Frame
Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)
Secondary Outcome Measure Information:
Title
Fear Measure
Description
The Childrens Fear Scale (CFS) is used to assess children's fear or anxiety levels. The one-item scale consists of five sex-neutral faces arranged from left to right with no fear in the center, through fear out to extreme fear.
Time Frame
Time Frame: Immediately after venipuncture (1-2 min.)
Other Pre-specified Outcome Measures:
Title
Pain and anxiety of children measured by parents and observe.
Description
outcomes Measured by Visual Analog Scale (VAS)
Time Frame
Time Frame: Immediately after venipuncture (1-2 minutes after procedure to mask observer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric patients 6-12 years old, Pediatric who needed peripheral cannulation, Exclusion Criteria: Children with chronic conditions, impairments physical, Disabilities with communicating difficulties, Those whose parent not participated, Neurodevelopmental delayed, can't verbal speak, hearing or visual impairments, Children with coma or drowsiness, have to take analgesic medication for less than 6 hrs. history of syncope.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akram Atrushi, Professor
Organizational Affiliation
Duhok University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Margareta Halek, Professor
Organizational Affiliation
Witten\Herdecke University
Official's Role
Study Director
Facility Information:
Facility Name
Sherzad Suleman
City
Witten
State/Province
NRW
ZIP/Postal Code
58455
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation

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