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

Primary Purpose

School Age Children, Blood, Procedural Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dry heat application
Dry cold application
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for School Age Children focused on measuring Blood sampling, Children, Dry heat, Dry cold, Pediatric nurse

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sağlık Bilimleri University Gulhane Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Dry heat application

Dry cold application

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Wong Baker Faces Pain Rating Scale
Refers to the pain felt due to the blood sample collection process.

Secondary Outcome Measures

Child Fear Scale
It expresses the fear of taking a blood sample, which is a painful procedure.
Child Anxiety Scale
It expresses the anxiety of taking a blood sample, which is a painful procedure.
Medical Procedures Fear Inventory
It refers to evaluating children's fears towards medical interventions.

Full Information

First Posted
July 11, 2023
Last Updated
August 2, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05974319
Brief Title
The Effect of Dry Heat and Dry Cold Application on Blood Sampling in Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
December 29, 2021 (Actual)
Study Completion Date
December 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
School Age Children, Blood, Procedural Pain, Procedural Anxiety, Fear
Keywords
Blood sampling, Children, Dry heat, Dry cold, Pediatric nurse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
During the blood sample collection, the application was carried out in line with the routine care.
Arm Title
Dry heat application
Arm Type
Experimental
Arm Description
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.
Arm Title
Dry cold application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry heat application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dry cold application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wong Baker Faces Pain Rating Scale
Description
Refers to the pain felt due to the blood sample collection process.
Time Frame
One minutes after blood sampling; once
Secondary Outcome Measure Information:
Title
Child Fear Scale
Description
It expresses the fear of taking a blood sample, which is a painful procedure.
Time Frame
Two minutes before blood sampling, Two minutes after blood sampling; twice.
Title
Child Anxiety Scale
Description
It expresses the anxiety of taking a blood sample, which is a painful procedure.
Time Frame
Two minutes before blood sampling, two minutes after blood sampling; twice.
Title
Medical Procedures Fear Inventory
Description
It refers to evaluating children's fears towards medical interventions.
Time Frame
Three minutes after blood sampling; once.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berna Eren Fidancı, RA
Organizational Affiliation
University of Sağlık Bilimleri
Official's Role
Study Director
Facility Information:
Facility Name
Sağlık Bilimleri University Gulhane Training and Research Hospital
City
Ankara
State/Province
Keçiören
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

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

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