School Age ChildrenNCT05974319
The Effect of Dry Heat and Dry Cold Application on Blood Sampling in Children
A study testing Dry heat application and Dry cold application in people with School Age Children and Blood, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- School Age Children, Blood, Procedural Pain
- What is being tested?
- Dry heat application and Dry cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2021to 29 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Those who do not meet the inclusion criteria
- Those who do not volunteer to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri University Gulhane Training and Research Hospital
Ankara, Keçiören, 06010
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- School Age Children, Blood, Procedural Pain, Procedural Anxiety, Fear
- Being tested
- Dry heat application, Dry cold application
- Keywords
- Blood sampling, Children, Dry heat, Dry cold, Pediatric nurse
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry heat applicationOther
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 applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dry cold application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong Baker Faces Pain Rating Scale
Refers to the pain felt due to the blood sample collection process.
Measured: One minutes after blood sampling; once
Secondary outcomes (3)
Child Fear Scale
It expresses the fear of taking a blood sample, which is a painful procedure.
Measured: Two minutes before blood sampling, Two minutes after blood sampling; twice.
Child Anxiety Scale
It expresses the anxiety of taking a blood sample, which is a painful procedure.
Measured: Two minutes before blood sampling, two minutes after blood sampling; twice.
Medical Procedures Fear Inventory
It refers to evaluating children's fears towards medical interventions.
Measured: Three minutes after blood sampling; once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start11 Jun 2021
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for School Age ChildrenStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Eren Fidancı, Saglik Bilimleri Universitesi
- Investigators
- Berna Eren Fidancı, RA, Study director, University of Sağlık Bilimleri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974319
- Sponsor's protocol ID
- GHF_MC1
- Status last verified
- Aug 2023
- First submitted
- 11 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37863785
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05974319
- Acronym / sponsor ID
- GHF_MC1
- Conditions
- School Age Children, Blood, Procedural Pain, Procedural Anxiety, Fear
- Keywords
- Blood sampling, Children, Dry heat, Dry cold, Pediatric nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Before blood sampling, the participants were assigned to the experiment 1-dry heat application, experiment 2-dry cold application and control groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –During the blood sample collection, the application was carried out in line with the routine care. |
| Dry heat application | Experimental | Other: Dry heat applicationThe 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 | Experimental | Other: Dry cold applicationThe 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Those who do not meet the inclusion criteria
- Those who do not volunteer to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry heat applicationDry 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 cold applicationDry 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. | Other | Dry cold application |
Primary outcome
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.
3 secondary outcomes
Child Fear Scale
Time frame: Two minutes before blood sampling, Two minutes after blood sampling; twice.
Child Anxiety Scale
Time frame: Two minutes before blood sampling, two minutes after blood sampling; twice.
Medical Procedures Fear Inventory
Time frame: Three minutes after blood sampling; once.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 37863785Cil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berna Eren Fidancı, RA study director
University of Sağlık Bilimleri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry heat application and Dry cold application in people with School Age Children and Blood, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong Baker Faces Pain Rating Scale (time frame: One minutes after blood sampling; once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.