Fear Clinical Trial
Official title:
The Effect of Dry Heat and Dry Cold Application on Pain, Anxiety and Fear Levels Before Blood Sample Collection in School Age Children: A Randomized Controlled Study
NCT number | NCT05974319 |
Other study ID # | GHF_MC1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 11, 2021 |
Est. completion date | December 29, 2021 |
Verified date | August 2023 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study was conducted as a parallel group randomized controlled in order to determine the effects of dry heat and dry cold application before blood collection in school-aged children (7-12 years old) on pain, anxiety and fear levels. Participants were randomly assigned to experiment 1-dry hot application group, experiment 2-dry cold application group and control group. In Experiment 1-Dry Heat Application group, a dry heat of 42°C was applied to the determined area with an electrical heating pad for 5 minutes before blood sample was taken. In Experiment 2-Dry Cold Application group, dry cold was applied to the area determined with a gel pad for 3 minutes before blood sample was taken. In the Control group, blood sampling was performed according to the clinical routine, and no heat or cold application was made.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 29, 2021 |
Est. primary completion date | December 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 12 Years |
Eligibility | Inclusion Criteria: - 7-12 years old - Absence of physical and mental illness - Absence of auditory, visual and verbal speech disability - Parents' willingness to participate in the research, and signing the volunteer form Exclusion Criteria: - Those who do not meet the inclusion criteria - Those who do not volunteer to participate |
Country | Name | City | State |
---|---|---|---|
Turkey | Saglik Bilimleri University Gulhane Training and Research Hospital | Ankara | Keçiören |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wong Baker Faces Pain Rating Scale | Refers to the pain felt due to the blood sample collection process. | One minutes after blood sampling; once | |
Secondary | Child Fear Scale | It expresses the fear of taking a blood sample, which is a painful procedure. | Two minutes before blood sampling, Two minutes after blood sampling; twice. | |
Secondary | Child Anxiety Scale | It expresses the anxiety of taking a blood sample, which is a painful procedure. | Two minutes before blood sampling, two minutes after blood sampling; twice. | |
Secondary | Medical Procedures Fear Inventory | It refers to evaluating children's fears towards medical interventions. | Three minutes after blood sampling; once. |
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