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| ID | Type | Description | Link |
|---|---|---|---|
| 7bRd8d6b | Registry Identifier | Istanbul University Cerrahpasa |
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| Name | Class |
|---|---|
| Istanbul University - Cerrahpasa | OTHER |
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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.
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;
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 group | Experimental | Patients in this group will be applied cold application with cold application bandage for 20 minutes as soon as the infusion begins. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Application | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Headache | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasemin K Uğurlu, MSCN | Contact | 05465674652 | yasemin_kalkan24@hotmail.com | |
| Nuray K Enç, Professör | Contact | 05337261618 | nurayenc@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Yasemin K Uğurlu | Ordu Üniversitesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuray Enc | Recruiting | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23901394 | Background | Sprouse-Blum AS, Gabriel AK, Brown JP, Yee MH. Randomized controlled trial: targeted neck cooling in the treatment of the migraine patient. Hawaii J Med Public Health. 2013 Jul;72(7):237-41. | |
| 20728068 | Background | Demir Y, Khorshid L. The effect of cold application in combination with standard analgesic administration on pain and anxiety during chest tube removal: a single-blinded, randomized, double-controlled study. Pain Manag Nurs. 2010 Sep;11(3):186-96. doi: 10.1016/j.pmn.2009.09.002. Epub 2010 May 31. |
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The study protocol will be shared after the study is finished.
Data will become available towards the end of 2022 and, it can be used for 1 year.
IPD Sharing will be make only for research.
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The quasi-experimental, two-group, pretest-posttest study
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| Yasemin Kalkan Uğurlu | Recruiting | Ordu | 52200 | Turkey (Türkiye) |
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| 22082021 | Background | Ertug N, Ulker S. The effect of cold application on pain due to chest tube removal. J Clin Nurs. 2012 Mar;21(5-6):784-90. doi: 10.1111/j.1365-2702.2011.03955.x. Epub 2011 Nov 15. |
| 28283812 | Result | Fraser F, Matsuzawa Y, Lee YSC, Minen M. Behavioral Treatments for Post-Traumatic Headache. Curr Pain Headache Rep. 2017 May;21(5):22. doi: 10.1007/s11916-017-0624-x. |
| 17173113 | Result | Ucler S, Coskun O, Inan LE, Kanatli Y. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study. Evid Based Complement Alternat Med. 2006 Dec;3(4):489-93. doi: 10.1093/ecam/nel035. Epub 2006 Jun 15. |