The Effect of Local Cold Application on Hypertension

NCT04998526 | Unknown

• 1 other identifier: yavuztez
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Cold application; Headache; Heart rate; Nursing

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Lowering blood pressure

  90 minute

Study Arms (3)

Experimental group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Experimental group OTHER

The cold gel pack will be applied to the nape.

Also known as: Cold application

Experimental group

Placebo group OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead
• Yuzuncu Yil University: collaborator

Study Sites (1)

Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service

Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Headache

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• YAVUZ ÜREN, PhD Student

  Ataturk University

  PRINCIPAL INVESTIGATOR

• EMİNE KIYAK, Prof.Dr.

  Ataturk University

  STUDY CHAIR

• SEVDEGÜL BİLVANİSİ, Prof.Dr.

  Yuzuncu Yil University

  STUDY CHAIR

Central Study Contacts

YAVUZ ÜREN, PhD Student

CONTACT

+905065961050; yavuzuren@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 10, 2021
• Study Start: August 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)