Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
128

Summary

Conditions
Headache
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A randomized controlled experimental studyMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

he 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 ...

he 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. Blood pressure above 150/90 mm / Hg. Purpose and Type of Research: This research was planned as a randomized controlled experimental study to determine the effect of the use of cold application bandages, which allows cold application to the frontotemporal and occipital areas of the patients at the same time, on the severity of headache and to compare these effects. 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: Patients in this group will be applied with a cold application bandage. 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. There is no previous study with a similar design for the experimentally designed study. Therefore, the power analysis was made based on a medium effect size. Groups will be assigned using http://stattrek.com/statistics/random-number-generator.aspx for the randomization of patients in the sample 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 (Cold application bandage users) and Control group. 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 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 control 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.

Tracking Information

NCT #
NCT04707586
Collaborators
Istanbul University-Cerrahpasa
Investigators
Principal Investigator: Yasemin K U?urlu Ordu Üniversitesi