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Completed

NCT Number: NCT05974319

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

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri University Gulhane Training and Research Hospital

Ankara, Keçiören, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dry heat application

Other

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

Other

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 outcomes

  1. 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

  1. Child Fear Scale

    Time frame: 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

    Time frame: 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

    Time frame: Three minutes after blood sampling; once.

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

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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