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Clinical Trials/NCT05974319
NCT05974319
Completed
Not Applicable

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

Saglik Bilimleri Universitesi1 site in 1 country120 target enrollmentJune 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
School Age Children
Sponsor
Saglik Bilimleri Universitesi
Enrollment
120
Locations
1
Primary Endpoint
Wong Baker Faces Pain Rating Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 11, 2021
End Date
December 29, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Berna Eren Fidancı

Associate professor

Saglik Bilimleri Universitesi

Eligibility Criteria

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

Outcomes

Primary Outcomes

Wong Baker Faces Pain Rating Scale

Time Frame: One minutes after blood sampling; once

Refers to the pain felt due to the blood sample collection process.

Secondary Outcomes

  • Child Anxiety Scale(Two minutes before blood sampling, two minutes after blood sampling; twice.)
  • Child Fear Scale(Two minutes before blood sampling, Two minutes after blood sampling; twice.)
  • Medical Procedures Fear Inventory(Three minutes after blood sampling; once.)

Study Sites (1)

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