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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04714255
Enrollment
100
Registered
2021-01-19
Start date
2019-11-03
Completion date
2020-02-05
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Art, Catheterization, Children, Pain

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.

Interventions

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.

Sponsors

University of Witten/Herdecke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Self-reported painImmediately 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

MeasureTime frameDescription
Fear MeasureTime 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

MeasureTime frameDescription
Pain and anxiety of children measured by parents and observe.Time Frame: Immediately after venipuncture (1-2 minutes after procedure to mask observeroutcomes Measured by Visual Analog Scale (VAS)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026