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

Primary Purpose

Venipuncture, Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Trace Image and Coloring for Kids-Book (TICK-B)
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venipuncture

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sherzad Suleman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TICK-B group as Intervention group

Standard care provided group as control group

Arm Description

Experimental: TICK-B group -Pediatric patients received TICK-B as a distraction in the TICK-B group

-Pediatric patients received standard care (routine care) in the control group.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
December 26, 2020
Last Updated
March 26, 2021
Sponsor
University of Witten/Herdecke
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1. Study Identification

Unique Protocol Identification Number
NCT04690257
Brief Title
Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture
Official Title
The Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venipuncture, Pain, Anxiety, Fear

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TICK-B group as Intervention group
Arm Type
Experimental
Arm Description
Experimental: TICK-B group -Pediatric patients received TICK-B as a distraction in the TICK-B group
Arm Title
Standard care provided group as control group
Arm Type
No Intervention
Arm Description
-Pediatric patients received standard care (routine care) in the control group.
Intervention Type
Other
Intervention Name(s)
Trace Image and Coloring for Kids-Book (TICK-B)
Intervention Description
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 Outcome Measure Information:
Title
Pain Intensity Measure
Description
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).
Time Frame
Immediately after venipuncture (1-2 min)
Secondary Outcome Measure Information:
Title
Fear Measure
Description
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.
Time Frame
Immediately after venipuncture (1-2 min. )
Other Pre-specified Outcome Measures:
Title
Pain and anxiety measured by parents and observe.
Description
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.
Time Frame
Immediately after venipuncture (1-2 min.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akram M Atrushi, Professor
Organizational Affiliation
Duhok University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Margareta Halek, Professor
Organizational Affiliation
Witten\Herdecke University
Official's Role
Study Director
Facility Information:
Facility Name
Sherzad Suleman
City
Witten
State/Province
NRW
ZIP/Postal Code
58455
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35512482
Citation
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.
Results Reference
derived

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

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