VenipunctureNCT04690257
Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture
A study testing Trace Image and Coloring for Kids-Book (TICK-B) in people with Venipuncture and Pain, run by University of Witten/Herdecke at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Venipuncture, Pain, Anxiety
- What is being tested?
- Trace Image and Coloring for Kids-Book (TICK-B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jan 2020to 1 Apr 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
- being between 6-12 years old,
- a physician order was placed for the blood sample,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial
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.
Read the 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,
- Conditions
- Venipuncture, Pain, Anxiety, Fear
- 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 pictures designed as a book contains and given to children during the procedure and they take a picture as they favored.
| Study group | Role | What they receive |
|---|---|---|
| TICK-B group as Intervention group | Experimental | Experimental: TICK-B group
-Pediatric patients received TICK-B as a distraction in the TICK-B group 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.
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).
Measured: Immediately after venipuncture (1-2 min)
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: 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 posted30 Dec 2020
- Study start10 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VenipunctureStudies 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
- 144 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 M Atrushi, Professor, Study chair, Duhok UniversityMargareta Halek, Professor, Study director, Witten\Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690257
- Sponsor's protocol ID
- SSKhudeida
- Status last verified
- Mar 2021
- First submitted
- 26 Dec 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35512482
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 Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04690257
- Acronym / sponsor ID
- SSKhudeida
- Conditions
- Venipuncture, Pain, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 30 Dec 2020 (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.
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 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)Experimental: TICK-B group -Pediatric patients received TICK-B as a distraction in the TICK-B group |
| 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)
- being between 6-12 years old,
- a physician order was placed for the blood sample,
Key exclusion criteria (6 listed)
- 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.
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 pictures designed as a book contains and given to children during the procedure and they take a picture as they favored. | Other | TICK-B group as Intervention group |
Primary outcome
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).
1 secondary outcome
Fear Measure
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.
- Derived from this study: PubMed 35512482Suleman 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.
- 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 M 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 Venipuncture 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 6 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?
Pain Intensity Measure (time frame: Immediately after venipuncture (1-2 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690257, which also lists 1 linked publication.
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.