The Effect of Local Cold Application on Hypertension

NCT ID: NCT04998526

Last Updated: 2021-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-03-31

Brief Summary

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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

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

After routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes.

Group Type EXPERIMENTAL

Experimental group

Intervention Type OTHER

The cold gel pack will be applied to the nape.

Placebo group

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.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type OTHER

The gel pack kept at room temperature will be applied to the nape.

Control group

Routine drug treatment will be given to hypertension patients and no application will be made.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental group

The cold gel pack will be applied to the nape.

Intervention Type OTHER

Placebo group

The gel pack kept at room temperature will be applied to the nape.

Intervention Type OTHER

Other Intervention Names

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Cold application

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role collaborator

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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YAVUZ ÜREN

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YAVUZ ÜREN, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

EMİNE KIYAK, Prof.Dr.

Role: STUDY_CHAIR

Ataturk University

SEVDEGÜL BİLVANİSİ, Prof.Dr.

Role: STUDY_CHAIR

Yuzuncu Yıl University

Locations

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Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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YAVUZ ÜREN, PhD Student

Role: CONTACT

+905065961050

Facility Contacts

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YAVUZ ÜREN, PhD Student

Role: primary

+905065961050

Other Identifiers

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yavuztez

Identifier Type: -

Identifier Source: org_study_id

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