Clinical trial NCT04998526: The Effect of Local Cold Application on Hypertension
Official title: The Effect of Local Cold Application on Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Cold application
Headache
Heart rate
Nursing
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Yuzuncu Yıl University
First posted: 2021-08-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood pressure
timeFrame: 90 minute
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service
Study officials:
affiliation: Ataturk University
name: YAVUZ ÜREN, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: EMİNE KIYAK, Prof.Dr.
role: STUDY_CHAIR
affiliation: Yuzuncu Yıl University
name: SEVDEGÜL BİLVANİSİ, Prof.Dr.
role: STUDY_CHAIR
References: