Clinical trial NCT04714255: Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
Official title: The Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization
Pain
Anxiety
Art
Children
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Peripheral Intravenous Cannulation (PIVC), one of the most common therapeutic procedures in medical care, can be difficult even for experienced medical practitioners. The pain of intravenous cannulation is considered the major limitation in pediatric clinical care. Reducing the pain of intravenous cannulation has been the motive for many investigations. Intervention methods used to reduce the distress related to painful procedures are widely recommended. The management of pain and anxiety is more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture-related pain and distress, with strong evidence supporting its efficacy in children.

Art therapy commonly used to reduce pain and anxiety of children's disease but was not used in reducing distress outcomes of painful procedures.

We used a collection of the image need for coloring and tracing called Trace Image and Coloring for Kids-Book (TICK-B).

The purpose of this study is to exam the effectiveness of TICK-B in decreasing pain and anxiety during cannulation.

Detailed description: Peripheral Intravenous Cannulation (PIVC), one of the most common therapeutic procedures in medical care, can be difficult even for experienced medical practitioners. The pain of intravenous cannulation is considered the major limitation in pediatric clinical care. Reducing the pain of intravenous cannulation has been the motive for many investigations. Intervention methods used to reduce the distress related to painful procedures are widely recommended. The management of pain and anxiety is more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture-related pain and distress, with strong evidence supporting its efficacy in children.

Art therapy commonly used to reduce pain and anxiety of children's disease but was not used in reducing distress outcomes of painful procedures.

We used a collection of the image need for coloring and tracing called Trace Image and Coloring for Kids-Book (TICK-B).

The purpose of this study is to exam the effectiveness of TICK-B in decreasing pain and anxiety during cannulation.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients 6-12 years old,
* Pediatric who needed peripheral cannulation,

Exclusion Criteria:

* Children with chronic conditions,
* impairments physical,
* Disabilities with communicating difficulties,
* Those whose parent not participated,
* Neurodevelopmental delayed, can't verbal speak, hearing or visual impairments,
* Children with coma or drowsiness,
* have to take analgesic medication for less than 6 hrs.
* history of syncope.

Primary outcomes:
measure: Self-reported pain
timeFrame: Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)
Secondary outcomes:
measure: Fear Measure
timeFrame: Time Frame: Immediately after venipuncture (1-2 min.)
Other outcomes:
measure: Pain and anxiety of children measured by parents and observe.
timeFrame: Time Frame: Immediately after venipuncture (1-2 minutes after procedure to mask observer
Locations:
city: Witten
country: Germany
facility: Sherzad Suleman
state: NRW
Study officials:
affiliation: Duhok University
name: Akram Atrushi, Professor
role: STUDY_CHAIR
affiliation: Witten\Herdecke University
name: Margareta Halek, Professor
role: STUDY_DIRECTOR
References: