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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2023
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Prior to blood sampling, parents and children were initially informed about the study in Experiment 1-dry heat, Experiment 2-dry cold, and control groups, and their written and verbal consents were obtained. After obtaining consent, information about the child and family was collected by the researcher with the "Child-Family Introductory Information Form" before the procedure. After the family and the child were introduced to the measurement tools (Wong Baker Faces Pain Scale, Child Fair Anxiety Scale and Medical Procedures Fear Inventory) to be scored, it was explained to the child that his mother or father would be with him during the procedure, and he was taken to the intervention room. Before the blood sample collection, the child's fear and anxiety were evaluated using Child Fear Anxiety Scale. In Experiment 1-Dry Heat Application group, the electrical heating pad with temperature regulation was heated by the researcher and set to 42°C. After making sure that there were no contraindications (deterioration of skin integrity, etc.) in the application of the electrical heating pad device, a dry heat of 42°C was applied to the determined area with an electrical heating pad for 5 minutes. In Experiment 2-Dry Cold Application group, dry cold was applied to the determined area with a gel pad for 3 minutes after the researcher made sure that there were no contraindications (deterioration of skin integrity, etc.) in the application of the gel pad. In the Control group, blood sampling was performed according to the clinical routine, and no heat or cold application was made.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Dry heat application
Dry heat application: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.
Dry cold application
Dry cold applicaiton: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.

Locations

Country Name City State
Turkey Saglik Bilimleri University Gulhane Training and Research Hospital Ankara Keçiören

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

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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