Pain Clinical Trial
Official title:
The Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial
Verified date | March 2021 |
Source | University of Witten/Herdecke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Sherzad Suleman | Witten | NRW |
Lead Sponsor | Collaborator |
---|---|
University of Witten/Herdecke |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain and anxiety measured by parents and observe. | 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. | Immediately after venipuncture (1-2 min.) | |
Primary | 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). | Immediately after venipuncture (1-2 min) | |
Secondary | 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. | Immediately after venipuncture (1-2 min. ) |
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