An observational study in Primary Headache Disorder, sponsored by Aksaray University Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Aksaray University Training and Research Hospital · Observational
Headache is one of the common causes of emergency department admissions and constitutes approximately 2%. Although the exact mechanism is not clear, It is known that high-flow oxygen therapy is effective in headache treatment. There are limited studies related to the use of oxygen therapy in headaches and its derivatives in the literature. In this study, the investigators aimed to compare the high and medium flow oxygen therapies with placebo in primary headache disorders.
Four different treatment methods were determined; 1) high-flow oxygen (15lt/min oxygen), 2) medium-flow oxygen (8lt/min oxygen), 3) high-flow room air as placebo (15 lt/min room air), 4) medium-flow room air as placebo (8 lt/min room air). All four treatment methods will be applied to all patients included in the study. One of the four treatments will be randomly applied at each separate ED admission with a gap of 1 week or more in between. This randomization will be performed by a computer at the time of admission. A study nurse will administer the patient's therapy according to the computer's current decision for 15 minutes. Patients and treating physicians will be blinded to the selected therapy. After 15 minutes of the end of treatment (at the 30th minute of the start of treatment), the treating physician will ask patients if they need rescue analgesia and analgesia will be administered if necessary. Additional analgesia is at the discretion of the treating physician. Patient data, including demographics, medical history, and findings of a physical examination performed before and after therapy will be recorded by the treating physician.
42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.
This study's enrollment of 132 is close to the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.
Browse Headache Disorders, Primary studies →Aksaray University Training and Research Hospital is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
all patients had one to six headache attacks per month which were started before 50 years old and were present for more than one year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 lt/min oxygen
Other: Oxygen therapy
8 lt/min oxygen
Other: Oxygen therapy
15 lt/min room air
Other: Oxygen therapy
8 lt/min room air
Other: Oxygen therapy
Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.
visual analog scale score
primary endpoint is the relative reduction in visual analog scale (a psychometric response scale) score in the placebo versus oxygen group to determine whether there was a difference between the high-flow and mid-flow therapies. visual analog scale scaled from 0-100 points with 0 meaning "no pain" and 100 points meaning "worst possible pain".
Time frame: 0-60 minutes
rescue analgesia
rescue analgesia (yes/no)
Time frame: 30 th minutes
length of stay
length of stay in the emergency department (time in minutes)
Time frame: 0-300 minutes
duration of a pain
duration of a pain attack (time in minutes)
Time frame: 0-300 minutes
readmission
readmission to the emergency department within 7 days (yes/no)
Time frame: 0-7 days
Plan to share: No
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Aksaray University Training and Research Hospital