NCT05974319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

July 11, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

Blood samplingChildrenDry heatDry coldPediatric nurse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Child Fear Scale

    Two minutes before blood sampling, Two minutes after blood sampling; twice.

  • Child Anxiety Scale

    Two minutes before blood sampling, two minutes after blood sampling; twice.

  • Medical Procedures Fear Inventory

    Three minutes after blood sampling; once.

Study Arms (3)

Control group

NO INTERVENTION

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

Dry heat application

EXPERIMENTAL

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 cold application

EXPERIMENTAL

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

Interventions

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 heat 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.

Dry cold application

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Those who do not volunteer to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri University Gulhane Training and Research Hospital

Ankara, Keçiören, 06010, Turkey (Türkiye)

Location

Related Publications (1)

  • Cil M, Fidanci BE. The effect of dry heat and dry cold application on pain, anxiety and fear levels before blood sample collection in school age children (7-12 years): A randomized controlled study. J Pediatr Nurs. 2023 Nov-Dec;73:e401-e408. doi: 10.1016/j.pedn.2023.10.008. Epub 2023 Oct 19.

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Berna Eren Fidancı, RA

    University of Sağlık Bilimleri

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Before blood sampling, the participants were assigned to the experiment 1-dry heat application, experiment 2-dry cold application and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 11, 2023

First Posted

August 3, 2023

Study Start

June 11, 2021

Primary Completion

December 29, 2021

Study Completion

December 29, 2021

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations