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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690257
• Other study ID #: SSKhudeida
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: April 1, 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

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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Fear
• Pain
• Venipuncture

Intervention

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.

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 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.)
Primary	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	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. )