CatheterizationNCT04714255
Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
A study testing Trace Image and Coloring for Kids-Book (TICK-B) in people with Catheterization and Pain, run by University of Witten/Herdecke at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Catheterization, Pain, Anxiety
- What is being tested?
- Trace Image and Coloring for Kids-Book (TICK-B)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 3 Nov 2019to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients 6-12 years old,
- Pediatric who needed peripheral cannulation,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
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.
Read more
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.
Read the 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.
- Conditions
- Catheterization, Pain, Anxiety, Art, Children
- Being tested
- Trace Image and Coloring for Kids-Book (TICK-B)
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trace Image and Coloring for Kids-Book (TICK-B)Other
A collection of images attractive that need to be colored, created as a book called TICK-B. This book was created with the instructions and recommendations of a pediatric psychiatrist and a professional drawing teacher at a children's school.Distraction with TICK-B began 1-3 min. before the intravenous cannula procedure and lasted until the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| TICK-B group as Intervention group | Experimental | Pediatric patients received TICK-B as a distraction in the TICK-B group Trace Image and Coloring for Kids-Book were conducted on the children undergoing the Cannulation procedure. Receives: Other: Trace Image and Coloring for Kids-Book (TICK-B) |
| Standard care provided group as control group | No intervention | Pediatric patients received standard care (routine care) in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain
Pain: The severity of pain measured by Faces Pain Scale-Revised (FPS-R): The FPS-R ranking is a 0-10 scale with the six cartoons.
Measured: Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)
Secondary outcomes (1)
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.
Measured: Time Frame: Immediately after venipuncture (1-2 min.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start3 Nov 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherzad Khudeida Suleman, University of Witten/Herdecke
- Investigators
- Akram Atrushi, Professor, Study chair, Duhok UniversityMargareta Halek, Professor, Study director, Witten\Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714255
- Sponsor's protocol ID
- SSK
- Status last verified
- Mar 2021
- First submitted
- 13 Jan 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation
- ClinicalTrials.gov ID
- NCT04714255
- Acronym / sponsor ID
- SSK
- Conditions
- Catheterization, Pain, Anxiety, Art, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TICK-B group as Intervention group | Experimental | Other: Trace Image and Coloring for Kids-Book (TICK-B)Pediatric patients received TICK-B as a distraction in the TICK-B group Trace Image and Coloring for Kids-Book were conducted on the children undergoing the Cannulation procedure. |
| Standard care provided group as control group | No intervention | –Pediatric patients received standard care (routine care) in the control group. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients 6-12 years old,
- Pediatric who needed peripheral cannulation,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trace Image and Coloring for Kids-Book (TICK-B)A collection of images attractive that need to be colored, created as a book called TICK-B. This book was created with the instructions and recommendations of a pediatric psychiatrist and a professional drawing teacher at a children's school.Distraction with TICK-B began 1-3 min. before the intravenous cannula procedure and lasted until the end of the procedure. | Other | TICK-B group as Intervention group |
Primary outcome
Self-reported pain
Time frame: Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)
Pain: The severity of pain measured by Faces Pain Scale-Revised (FPS-R): The FPS-R ranking is a 0-10 scale with the six cartoons.
1 secondary outcome
Fear Measure
Time frame: Time Frame: Immediately after venipuncture (1-2 min.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akram Atrushi, Professor study chair
Duhok University
Margareta Halek, Professor study director
Witten\Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trace Image and Coloring for Kids-Book (TICK-B) in people with Catheterization and Pain, run by University of Witten/Herdecke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain (time frame: Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.