The Effect of Local Cold Application on Hypertension

August 4, 2021 updated by: YAVUZ ÜREN, Ataturk University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • VAN, Turkey, 65080
        • Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
After routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes.
Other: Experimental group
The cold gel pack will be applied to the nape.
Other Names:
  • Cold application
Placebo Comparator: 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.
Other: Placebo group
The gel pack kept at room temperature will be applied to the nape.
No Intervention: Control group
Routine drug treatment will be given to hypertension patients and no application will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 90 minute
Lowering blood pressure
90 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Collaborators

Yuzuncu Yıl University

Investigators

  • Principal Investigator: YAVUZ ÜREN, PhD Student, Ataturk University
  • Study Chair: EMİNE KIYAK, Prof.Dr., Ataturk University
  • Study Chair: SEVDEGÜL BİLVANİSİ, Prof.Dr., Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yavuztez

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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