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

Sponsor
University of Witten/Herdecke (Other)
Overall Status
Completed
CT.gov ID
NCT04714255
Collaborator
(none)
100
1
2
3.1
32.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Trace Image and Coloring for Kids-Book (TICK-B)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
Actual Study Start Date :
Nov 3, 2019
Actual Primary Completion Date :
Feb 5, 2020
Actual Study Completion Date :
Feb 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: TICK-B group as Intervention group

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.

Other: Trace Image and Coloring for Kids-Book (TICK-B)
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.

No Intervention: Standard care provided group as control group

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

Outcome Measures

Primary Outcome Measures

  1. Self-reported pain [Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)]

    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

  1. Fear Measure [Time Frame: Immediately after venipuncture (1-2 min.)]

    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.

Other Outcome Measures

  1. Pain and anxiety of children measured by parents and observe. [Time Frame: Immediately after venipuncture (1-2 minutes after procedure to mask observer]

    outcomes Measured by Visual Analog Scale (VAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sherzad Suleman Witten NRW Germany 58455

Sponsors and Collaborators

  • University of Witten/Herdecke

Investigators

  • Study Chair: Akram Atrushi, Professor, Duhok University
  • Study Director: Margareta Halek, Professor, Witten\Herdecke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sherzad Khudeida Suleman, Principal Investigator (PhD Student), University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT04714255
Other Study ID Numbers:
  • SSK
First Posted:
Jan 19, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021