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

NCT04714255 | Completed

• 1 other identifier: SSK
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheterization; Pain; Anxiety; Art; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fear Measure

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

Other Outcomes (1)

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

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

Study Arms (2)

TICK-B group as Intervention group

EXPERIMENTAL

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)

Standard care provided group as control group

NO INTERVENTION

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

Interventions

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.

TICK-B group as Intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients 6-12 years old,
• Pediatric who needed peripheral cannulation,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

Sherzad Suleman

Witten, North Rhine-Westphalia, 58455, Germany

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Akram Atrushi, Professor

  Duhok University

  STUDY CHAIR

• Margareta Halek, Professor

  Witten\Herdecke University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PhD Student)

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: November 3, 2019
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)