The Effect of Local Cold Application on Hypertension

Hypertension Clinical Trial

Official title:

The Effect of Local Cold Application on Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04998526
• Other study ID #: yavuztez
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: March 2022

Study information

• Verified date: August 2021
• Source: Ataturk University
• Contact: YAVUZ ÜREN, PhD Student
• Phone: +905065961050
• Email: yavuzuren[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Experimental group
The cold gel pack will be applied to the nape.
• Placebo group
The gel pack kept at room temperature will be applied to the nape.

Locations

Country	Name	City	State
Turkey	Van Yüzüncü Yil University Dursun Odabas Medical Centre Emergency Service	VAN

Sponsors (2)

Lead Sponsor	Collaborator
Ataturk University	Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Lowering blood pressure	90 minute