Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture

The Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial

Venipuncture is one of the most common stressful procedures in children. Managing pain and fear of venipuncture procedure recommended strongly because it may change children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.

There was clear evidence that the distraction method is the most performed as a psychological technique performed to decrease venipuncture-related pain and distress and supporting its efficacy in children.

The aim of this study to investigate the effectiveness of TICK-B on children's pain and anxiety during venipuncture procedure.

Study Overview

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

Detailed Description

Note:

The first registration number for the protocol of Ph.D. was approved as 10092019-6 on 10th September 2019 It approved the grant to publish the result as 20072020-3 on 23, August,

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• being between 6-12 years old,
• a physician order was placed for the blood sample,

Exclusion Criteria:

• Chronic medical condition.
• Those whose parent not participated,
• Neurodevelopmental delayed, verbal difficulties, difficulties in hearing or visual,
• Unconsciousness.
• Take a medication analgesic in the past 6 hrs.
• history of syncope.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TICK-B group as Intervention group; Experimental: TICK-B group -Pediatric patients received TICK-B as a distraction in the TICK-B group	Other: Trace Image and Coloring for Kids-Book (TICK-B); A collection of pictures designed as a book contains and given to children during the procedure and they take a picture as they favored.
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
Pain Intensity Measure	Wong-Baker faces scale (WBFS). Used to measure the pain severity during the procedure, the WB-FBRS is a series of six cartoon faces positioned side-by-side from the greatest pain to the mildest one (0-5).	Immediately after venipuncture (1-2 min)

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.	Immediately after venipuncture (1-2 min. )

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and anxiety measured by parents and observe.	Visual Analog Scale (VAS) was used to measure the pain and fear of children by parents and observer. A rating of 0 represents no pain and 10 represents the worst or most severe pain. The VAS is a valid, reliable, and frequently used measure of procedural distress in children 6 to 18 years of age.	Immediately after venipuncture (1-2 min.)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Suleman SK, Atrushi A, Enskar K. Effectiveness of art-based distraction on reducing pediatric patients' pain and anxiety during venipuncture: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101597. doi: 10.1016/j.ctcp.2022.101597. Epub 2022 Apr 30.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: December 26, 2020
• First Submitted That Met QC Criteria: December 26, 2020
• First Posted (Actual): December 30, 2020

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: SSKhudeida

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