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

Not Applicable

Completed

• Conditions: Venipuncture; Anxiety; Fear; Pain
• Interventions: Other: Trace Image and Coloring for Kids-Book (TICK-B)

• Registration Number: NCT04690257
• Lead Sponsor: University of Witten/Herdecke

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.

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 Timeline

• Study Start: 2020-01-10
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Study First Submitted: 2020-12-26
• Study First Submitted QC: 2020-12-26
• Study First Posted: 2020-12-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TICK-B group as Intervention group	Trace Image and Coloring for Kids-Book (TICK-B)	Experimental: TICK-B group -Pediatric patients received TICK-B as a distraction in the TICK-B group

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measure	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 Outcome Measures

Name	Time	Method
Fear Measure	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.

Trial Locations

Locations (1)

Sherzad Suleman; 🇩🇪 Witten, NRW, Germany