Lokal Cold Application in Nitroglycerin-Induced Headache (NIH)

September 2, 2021 updated by: Yasemin Kalkan Uğurlu

The Effect of Lokal Cold Application in Nitroglycerin-Induced Headache

The study was planned to evaluate the effect of local cold application on headache severity in individuals who received intravenous nitroglycerin treatment, which mostly causes headache due to its vasoditator effect. It is thought that the results to be obtained may provide evidence for the development of patient care guidelines.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study was planned to evaluate the effect of local cold application on headache severity in individuals who received intravenous nitroglycerin treatment, which mostly causes headache due to its vasoditator effect.

Inclusion criteria;

  • The patient's volunteerism to participate in the research,
  • Over the age of 18,
  • Being conscious,
  • Any analgesic, NSAID, triptan etc. Not taking antimigren drugs or opioids,
  • No cold allergies. Exclusion Criteria;
  • Difficulty in communicating (speaking, perception, language, comprehension problems),
  • Vision and / or hearing loss,
  • Having a cold allergy.

Purpose and Type of Research:

This research was planned as a quasi-experimental, two-group, pretest-posttest study to determine the effect of local cold application on headache in individuals treated with intravenous NTG, which mostly causes headache due to its vasodilator effect.

Place and Time of the Study It will be carried out in Ordu State Hospital Coronary Intensive Care Unit between 15 December 2020 - 15 December November 2021.

Research Population and Sample The universe of the study is planned to be composed of all patients who were hospitalized in Ordu State Hospital Coronary Intensive Care Unit between December 2020 and December 2021 and received intravenous nitroglycerine treatment.

The sample of the study will be the patients who meet the sample selection criteria and are willing to participate in the study. The research sample will consist of experimental and control groups.

Experiment 1:Local cold application was applied to the patients with the help of the applicator during the first 20 minutes of the nitroglycerin infusion. The patient was followed up during the cold application, after the procedure, the patient was evaluated in detail using the Patient Follow-up Form and VAS, and his questions were answered. The patient was given detailed information about the application before the procedure.

Experiment 2: The patients were evaluated in detail using the Patient Follow-up Form and VAS for the first 12 hours of the infusion. Local cold application was applied for 20 minutes with the help of the applicator to the patients who developed headache. Immediately after the cold application, it was evaluated in detail using the Patient Follow-up Form and VAS. The groups were compared according to the data obtained.

Power analysis (G*Power 3.1.9.2) was performed to determine the sample size of the study. As a result of the analysis; In the evaluation made according to headache severity, the sample size determined for Power:0.80, β:0.20 and α:0.05 is a minimum of 14 patients for each group. However, to increase the reliability of the study and considering that there may be patients who could leave the study during the study, the total number of samples was determined as 70, 35 in the experimental 1 group and 35 in the experimental 2 group.

Data Collection Method

  • Individuals who meet the criteria for inclusion in the sampling will be informed about the purpose, content and method of the research, and after the randomization process, experimental and control groups will be formed by obtaining the necessary written permission from those who agree to participate in the study.
  • The research will consist of 2 groups as Experiment 1(Group of Local Cold Application at the Beginning of Infusion) and Experiment 2 (The Group Not Applying Local Cold at the Beginning of Infusion)
  • Data will be collected by the researcher.
  • Within the scope of the research, the patients in the experimental group who used the cold application bandage will be informed about the use of the bandage.
  • Patient Information Form, Patient Follow-up Form and Visual Pain Perception Scale will be used to evaluate the sociodemographic, disease, treatment and pain level of all patients participating in the study prior to nitroglycerin infusion.
  • A cold application bandage will be attached to the experimental 1 group and local cold application will be applied to the patient for the first 20 minutes of the nitroglycerine infusion. After 20 minutes, the bandage will be removed from the patient and the cold application will be terminated. The patient will be followed during the cold application, and the questions of the patient will be answered after the procedure. Immediately after the cold application, the patient's headache will be evaluated in detail using the Visual Pain Perception Scale and the Patient Follow-up Form.
  • Patients in the experimental 2 group who develop headaches will be evaluated in detail using the Visual Pain Perception Scale and the Patient Follow-up Form, a cold application bandage will be worn and local cold application will be performed for 20 minutes. Immediately after the cold application, it will be evaluated in detail again using the Visual Pain Perception Scale and Patient Monitoring Form. In this way, the preventive and therapeutic effect of local cold application will be evaluated in patients receiving intravenous nitroglycerin treatment.
  • Groups will be compared according to the data obtained.

Study Type

Interventional

Enrollment (Anticipated)

70

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 Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Nuray Enc
        • Contact:
      • Ordu, Turkey, 52200

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient's volunteerism to participate in the research,
  • Over the age of 18,
  • Being conscious,
  • Any analgesic, NSAID, triptan etc. Not taking antimigren drugs or opioids,
  • No cold allergies.

Exclusion Criteria:

  • Difficulty in communicating (speaking, perception, language, comprehension problems),
  • Vision and / or hearing loss,
  • Having a cold allergy.
  • Blood pressure above 150/90 mm / Hg.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
No application will be made to patients in this group. Routine patient care will be provided. After the patients who develop pain are recorded, the application will be made with a cold application bandage.
EXPERIMENTAL: experimental group
Patients in this group will be applied cold application with cold application bandage for 20 minutes as soon as the infusion begins.
Other: Cold Application
Created by the researcher; A bandage with 3 pieces of 13x10 cm cold gel and a cold gel container in which they are placed will be used, which can be adjusted according to the head circumference of the patient between 60-80 cm in length. The ability of the cold gel cups of the bandage to be moved on the bandage will allow comfortable cold application to the patient's bilateral frontotemporal and occipital areas at the same time. After waiting for 20 minutes in the freezer part of the refrigerator, the temperature and temperature of the gels applied and the cold application area before and after each application will be measured and recorded. An Infrared Non-Contact Food Thermometer will be used for temperature measurement of cold gel packs, and an Infrared Non-Contact Thermometer device will be used for temperature measurement of the cold application area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache
Time Frame: 30 minutes, 3.,6., 9. and 12. hours after nitroglycerin infusion starts
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance between 'no pain' and the mark then defines the subject's pain.
30 minutes, 3.,6., 9. and 12. hours after nitroglycerin infusion starts

Collaborators and Investigators

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

Sponsor

Yasemin Kalkan Uğurlu

Collaborators

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Yasemin K Uğurlu, Ordu Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

December 15, 2020

Primary Completion (ANTICIPATED)

January 15, 2022

Study Completion (ANTICIPATED)

March 15, 2022

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9080
  • 7bRd8d6b (REGISTRY: Istanbul University Cerrahpasa)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol will be shared after the study is finished.

IPD Sharing Time Frame

Data will become available towards the end of 2022 and, it can be used for 1 year.

IPD Sharing Access Criteria

IPD Sharing will be make only for research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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