The Effect of Dry Heat and Dry Cold Application on Blood Sampling in Children

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05974319
• Other study ID #: GHF_MC1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood
• Fear
• Pain, Procedural
• Procedural Anxiety
• Procedural Pain

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.