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

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

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 Overview

• Status: Completed
• Conditions: Pain; Anxiety; Children; Catheterization; Art
• Intervention / Treatment: Other: Trace Image and Coloring for Kids-Book (TICK-B)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Witten, NRW, Germany, 58455
      • Sherzad Suleman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Time Frame: Immediately after venipuncture (1-2 min.)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and anxiety of children measured by parents and observe.	outcomes Measured by Visual Analog Scale (VAS)	Time Frame: Immediately after venipuncture (1-2 minutes after procedure to mask observer

Collaborators and Investigators

• Sponsor: University of Witten/Herdecke
• Investigators: Study Chair: Akram Atrushi, Professor, Duhok university

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2019
• Primary Completion (ACTUAL): February 5, 2020
• Study Completion (ACTUAL): February 5, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: SSK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No