Lokal Cold Application in Nitroglycerin-Induced Headache (NIH)
The Effect of Lokal Cold Application in Nitroglycerin-Induced Headache
2 other identifiers
interventional
70
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2020
CompletedFirst Submitted
Initial submission to the registry
December 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedSeptember 10, 2021
September 1, 2021
1.1 years
December 23, 2020
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control
NO INTERVENTIONNo 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
EXPERIMENTALPatients in this group will be applied cold application with cold application bandage for 20 minutes as soon as the infusion begins.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Difficulty in communicating (speaking, perception, language, comprehension problems),
- Vision and / or hearing loss,
- Having a cold allergy.
- Blood pressure above 150/90 mm / Hg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yasemin Kalkan Uğurlulead
- Istanbul University - Cerrahpasacollaborator
Study Sites (2)
Nuray Enc
Istanbul, Turkey (Türkiye)
Yasemin Kalkan Uğurlu
Ordu, 52200, Turkey (Türkiye)
Related Publications (5)
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.
PMID: 23901394BACKGROUNDDemir 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.
PMID: 20728068BACKGROUNDErtug 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.
PMID: 22082021BACKGROUNDFraser 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.
PMID: 28283812RESULTUcler 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.
PMID: 17173113RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasemin K Uğurlu
Ordu Üniversitesi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Assistant MScN
Study Record Dates
First Submitted
December 23, 2020
First Posted
January 13, 2021
Study Start
December 15, 2020
Primary Completion
January 15, 2022
Study Completion
March 15, 2022
Last Updated
September 10, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available towards the end of 2022 and, it can be used for 1 year.
- Access Criteria
- IPD Sharing will be make only for research.
The study protocol will be shared after the study is finished.