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

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT05974319
Collaborator
(none)
120
1
3
6.6
18.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dry heat application
  • Other: Dry cold application
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Before blood sampling, the participants were assigned to the experiment 1-dry heat application, experiment 2-dry cold application and control groups.Before blood sampling, the participants were assigned to the experiment 1-dry heat application, experiment 2-dry cold application and control groups.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Jun 11, 2021
Actual Primary Completion Date :
Dec 29, 2021
Actual Study Completion Date :
Dec 29, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

During the blood sample collection, the application was carried out in line with the routine care.

Experimental: 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.

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.

Experimental: Dry cold application

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Wong Baker Faces Pain Rating Scale [One minutes after blood sampling; once]

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

Secondary Outcome Measures

  1. Child Fear Scale [Two minutes before blood sampling, Two minutes after blood sampling; twice.]

    It expresses the fear of taking a blood sample, which is a painful procedure.

  2. Child Anxiety Scale [Two minutes before blood sampling, two minutes after blood sampling; twice.]

    It expresses the anxiety of taking a blood sample, which is a painful procedure.

  3. Medical Procedures Fear Inventory [Three minutes after blood sampling; once.]

    It refers to evaluating children's fears towards medical interventions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sağlık Bilimleri University Gulhane Training and Research Hospital Ankara Keçiören Turkey 06010

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi

Investigators

  • Study Director: Berna Eren Fidancı, RA, University of Sağlık Bilimleri

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Berna Eren Fidancı, Associate professor, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT05974319
Other Study ID Numbers:
  • GHF_MC1
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Berna Eren Fidancı, Associate professor, Saglik Bilimleri Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023