The Effect of Local Cold Application on Hypertension

Not Applicable

• Conditions: Hypertension
• Interventions: Other: Experimental group; Other: Placebo group

• Registration Number: NCT04998526
• Lead Sponsor: Ataturk University

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.

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Study First Posted: 2021-08-10
• Last Update Posted: 2021-08-10
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Experimental group	After routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes.
Placebo group	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure	90 minute	Lowering blood pressure

Trial Locations

Locations (1)

Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service; 🇹🇷 VAN, Turkey