HypertensionNCT04998526
The Effect of Local Cold Application on Hypertension
A study testing Experimental group in people with Hypertension, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Experimental group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2021to Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 mg sublingual ACE inhibitor given as a treatment protocol,
- No wound on the nape,
- Does not develop cold intolerance,
- Not taking any hypertension medication and pain medication in the last 6 hours,
- Without heart diseases, peripheral arterial circulation disorders, sensory disorders and edema,
- Not pregnant,
- Agreeing to participate in the study,
- Essential hypertension patients with systolic blood pressure 160 - 179 mmHg, diastolic blood pressure 100 - 109 mmHg.
Who cannot join
- Developing cold intolerance,
- Changes in the treatment regimen,
- Panic attack, allergic reaction and any similar situation develops,
- Those who want to withdraw from the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service
Van, 65080
YAVUZ ÜREN, PhD Student, +905065961050, yavuzuren@hotmail.com
About this study
This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.
Read the detailed description
Aim: This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.
Material and method: This study, which is planned as a randomized controlled and experimental study, will be conducted with type 2 (systolic blood pressure between 160 and 179 mmHg, diastolic blood pressure between 100 and 109 mmHg) essential hypertension patients who refer to Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service. The patients will be distributed as 24 in experimental group, 24 in placebo group and 24 in control group based on block randomization (gender and age) method and a total of 72 patients will be included. Patient information form, blood pressure and heart rate monitoring form and VAS pain scale will be used to collect study data. Patients in all groups will be measured in 90 minutes for a total of 8 times, as pre-test (pre-application) and post-test (minutes 3, 10, 15, 20, 30, 60 and 90). After routine medication therapy is given to all three groups, the cold gel pack which has been kept at least for four hours in the freezer will be applied to the nape of the patients in the experimental group, while gel pack at room temperature will be applied to the placebo group and no application will be made to the control group. Variance analysis, Friedman analysis, t test, Wilcoxon test and Kruskal Wallis analysis will be used in data assessment.
- Conditions
- Hypertension
- Being tested
- Experimental group, Placebo group
- Keywords
- Cold application, Headache, Heart rate, Nursing
- Medical subject headings
- Hypertension, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Also called Cold application
The cold gel pack will be applied to the nape.
Placebo groupOther
The gel pack kept at room temperature will be applied to the nape.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | After routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes. Receives: Other: Experimental group |
| Placebo group | Placebo comparator | After routine drug therapy is given to hypertension patients, the gel pack kept at room temperature will be applied to the nape for 3 minutes. Receives: Other: Placebo group |
| Control group | No intervention | Routine drug treatment will be given to hypertension patients and no application will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Lowering blood pressure
Measured: 90 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study, which is planned as a randomized controlled and experimental study, will be conducted with type 2 (systolic blood pressure between 160 and 179 mmHg, diastolic blood pressure between 100 and 109 mmHg) essential hypertension patients who refer to Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service. The patients will be distributed as 24 in experimental group, 24 in placebo group and 24 in control group based on block randomization (gender and age) method and a total of 72 patients will be included.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Principal investigator, YAVUZ ÜREN, Ataturk University
- Investigators
- YAVUZ ÜREN, PhD Student, Principal investigator, Ataturk UniversityEMİNE KIYAK, Prof.Dr., Study chair, Ataturk UniversitySEVDEGÜL BİLVANİSİ, Prof.Dr., Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998526
- Sponsor's protocol ID
- yavuztez
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Cold Application on Hypertension
- ClinicalTrials.gov ID
- NCT04998526
- Acronym / sponsor ID
- yavuztez
- Conditions
- Hypertension
- Keywords
- Cold application, Headache, Heart rate, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Yuzuncu Yil University
- Study start
- Aug 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 10 Aug 2021 (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.
This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.
Detailed description
Aim: This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.
Material and method: This study, which is planned as a randomized controlled and experimental study, will be conducted with type 2 (systolic blood pressure between 160 and 179 mmHg, diastolic blood pressure between 100 and 109 mmHg) essential hypertension patients who refer to Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service. The patients will be distributed as 24 in experimental group, 24 in placebo group and 24 in control group based on block randomization (gender and age) method and a total of 72 patients will be included. Patient information form, blood pressure and heart rate monitoring form and VAS pain scale will be used to collect study data. Patients in all groups will be measured in 90 minutes for a total of 8 times, as pre-test (pre-application) and post-test (minutes 3, 10, 15, 20, 30, 60 and 90). After routine medication therapy is given to all three groups, the cold gel pack which has been kept at least for four hours in the freezer will be applied to the nape of the patients in the experimental group, while gel pack at room temperature will be applied to the placebo group and no application will be made to the control group. Variance analysis, Friedman analysis, t test, Wilcoxon test and Kruskal Wallis analysis will be used in data assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study, which is planned as a randomized controlled and experimental study, will be conducted with type 2 (systolic blood pressure between 160 and 179 mmHg, diastolic blood pressure between 100 and 109 mmHg) essential hypertension patients who refer to Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service. The patients will be distributed as 24 in experimental group, 24 in placebo group and 24 in control group based on block randomization (gender and age) method and a total of 72 patients will be included.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupAfter routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes. |
| Placebo group | Placebo comparator | Other: Placebo groupAfter routine drug therapy is given to hypertension patients, the gel pack kept at room temperature will be applied to the nape for 3 minutes. |
| Control group | No intervention | –Routine drug treatment will be given to hypertension patients and no application will be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 25 mg sublingual ACE inhibitor given as a treatment protocol,
- No wound on the nape,
- Does not develop cold intolerance,
- Not taking any hypertension medication and pain medication in the last 6 hours,
- Without heart diseases, peripheral arterial circulation disorders, sensory disorders and edema,
Key exclusion criteria (4 listed)
- Developing cold intolerance,
- Changes in the treatment regimen,
- Panic attack, allergic reaction and any similar situation develops,
- Those who want to withdraw from the research
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 |
|---|---|---|
| Experimental groupAlso: Cold applicationThe cold gel pack will be applied to the nape. | Other | Experimental group |
| Placebo groupThe gel pack kept at room temperature will be applied to the nape. | Other | Placebo group |
Primary outcome
Blood pressure
Time frame: 90 minute
Lowering blood pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
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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.
YAVUZ ÜREN, PhD Student principal investigator
Ataturk University
EMİNE KIYAK, Prof.Dr. study chair
Ataturk University
SEVDEGÜL BİLVANİSİ, Prof.Dr. study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Hypertension, run by Ataturk University 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YAVUZ ÜREN, PhD Student (+905065961050, yavuzuren@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 90 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2021.