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Completed

NCT Number: NCT04714255

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.

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Key information

Conditions

Catheterization ART Anxiety Anxiety Disorders Children Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sherzad Suleman

Witten, North Rhine-Westphalia, 58455, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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 outcomes

  1. Self-reported pain

    Time frame: 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 outcomes

  1. Fear Measure

    Time frame: 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 outcomes

  1. Pain and anxiety of children measured by parents and observe.

    Time frame: Time Frame: Immediately after venipuncture (1-2 minutes after procedure to mask observer

    outcomes Measured by Visual Analog Scale (VAS)

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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