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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714255
• Other study ID #: SSK
• Status: Completed
• Phase: N/A
• Start date: November 3, 2019
• Est. completion date: February 5, 2020

Study information

• Verified date: March 2021
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Art
• Catheterization
• Children
• Pain

Intervention

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.

Locations

Country	Name	City	State
Germany	Sherzad Suleman	Witten	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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.)