Skip to main content
OpenTrials
Completed

NCT Number: NCT04690257

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venipuncture Anxiety Anxiety Disorders Fear Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sherzad Suleman

Witten, North Rhine-Westphalia, 58455, Germany

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain Intensity Measure

    Time frame: Immediately after venipuncture (1-2 min)

    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).

Secondary outcomes

  1. Fear Measure

    Time 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 outcomes

  1. Pain and anxiety measured by parents and observe.

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

    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.

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2020
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.