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The Effect of Local Cold Application on Hypertension

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Experimental group
Placebo group
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Cold application, Headache, Heart rate, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Experimental group

Placebo group

Control group

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Blood pressure
Lowering blood pressure

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
August 4, 2021
Sponsor
Ataturk University
Collaborators
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT04998526
Brief Title
The Effect of Local Cold Application on Hypertension
Official Title
The Effect of Local Cold Application on Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
Collaborators
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Cold application, Headache, Heart rate, Nursing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
After routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine drug treatment will be given to hypertension patients and no application will be made.
Intervention Type
Other
Intervention Name(s)
Experimental group
Other Intervention Name(s)
Cold application
Intervention Description
The cold gel pack will be applied to the nape.
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
The gel pack kept at room temperature will be applied to the nape.
Primary Outcome Measure Information:
Title
Blood pressure
Description
Lowering blood pressure
Time Frame
90 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YAVUZ ÜREN, PhD Student
Phone
+905065961050
Email
yavuzuren@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YAVUZ ÜREN, PhD Student
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
EMİNE KIYAK, Prof.Dr.
Organizational Affiliation
Ataturk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
SEVDEGÜL BİLVANİSİ, Prof.Dr.
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Study Chair
Facility Information:
Facility Name
Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service
City
VAN
ZIP/Postal Code
65080
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YAVUZ ÜREN, PhD Student
Phone
+905065961050
Email
yavuzuren@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Local Cold Application on Hypertension

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