Clinical trial NCT05974319: 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
Overall status: COMPLETED
Phase: NA
Conditions: School Age Children
Blood
Procedural Pain
Procedural Anxiety
Fear
Keywords: Blood sampling
Children
Dry heat
Dry cold
Pediatric nurse
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Wong Baker Faces Pain Rating Scale
timeFrame: One minutes after blood sampling; once
Secondary outcomes:
measure: Child Fear Scale
timeFrame: Two minutes before blood sampling, Two minutes after blood sampling; twice.
measure: Child Anxiety Scale
timeFrame: Two minutes before blood sampling, two minutes after blood sampling; twice.
measure: Medical Procedures Fear Inventory
timeFrame: Three minutes after blood sampling; once.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sağlık Bilimleri University Gulhane Training and Research Hospital
state: Keçiören
Study officials:
affiliation: University of Sağlık Bilimleri
name: Berna Eren Fidancı, RA
role: STUDY_DIRECTOR
References: