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

NCT04690257 | Completed

• 1 other identifier: SSKhudeida
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venipuncture; Pain; Anxiety; Fear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fear Measure

  Immediately after venipuncture (1-2 min. )

Other Outcomes (1)

• Pain and anxiety measured by parents and observe.

  Immediately after venipuncture (1-2 min.)

Study Arms (2)

TICK-B group as Intervention group

EXPERIMENTAL

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)

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 pictures designed as a book contains and given to children during the procedure and they take a picture as they favored.

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:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

Sherzad Suleman

Witten, North Rhine-Westphalia, 58455, Germany

Location

Related Publications (1)

• 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.

  PMID: 35512482 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Akram M 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: December 26, 2020
• First Posted: December 30, 2020
• Study Start: January 10, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)