Determining the effect of oxygen therapy on patients referred to Kashani hospital emergency department for headache for 15 to 60 minutes by visual analog scale (VAS).
Design
Patients will be divided into two intervention and control groups based on a random number table, sample size 60 (30 people in each group), double-blind.
Settings and conduct
This study will be performed in the emergency department of Kashani hospital in Shahrekord.
Participants/Inclusion and exclusion criteria
Age between 18 to 50 years, no mental illness, no brain pathology (brain CT obtained from all patients) or neurological defects in the examination, no high blood pressure, no cancer, no pregnancy or lactation, willingness to cooperate, absence of lung diseases such as asthma, pneumonia, absence of any previous disease being treated.
Intervention groups
Control group: in addition to routine treatment, a mask attached to the air container will be located for the patient. Intervention group, in addition to the painkiller, oxygen therapy will be started with a non-rebreather mask. The amount of oxygen consumed will be at least 15 liters. The amount of pain will be measured and recorded using VAS 0, 15, 30, 45, and 60 minutes after the start of treatment by the patient.
Main outcome variables
Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210907052404N1
Registration date:2021-09-25, 1400/07/03
Registration timing:registered_while_recruiting
Last update:2021-09-25, 1400/07/03
Update count:0
Registration date
2021-09-25, 1400/07/03
Registrant information
Name
Mahshid Barzegar Ghahfarokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3242 4484
Email address
msh_barzegar_gh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Oxygen Therapy on Patients with Headache Referred to Kashani’s Emergency Room for 15 to 60 Minutes
Public title
Effect of Oxygen Therapy on Patients with Headache Referred to Kashani’s Emergency Room for 15 to 60 Minutes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 50 years
No brain pathologies (brain CT obtained from all patients) or neurological defects on examination
No high blood pressure
No cancer
No pregnancy and lactation
Absence of lung diseases such as asthma, pneumonia
Absence of any previous disease to be treated.
Exclusion criteria:
Reluctance to cooperate with the study.
Patients with pathological lesions
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into 2 groups equally by Permuted Block Randomization method. In each list, separate blocks of 2 will be placed randomly using a random table of numbers. In each list, the order of treatment is determined and therefore, using the double blocks defined based on the random table, patients will be placed in equal numbers in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patients and the statistical consultant will not know which group the patients belong to and what type of treatment the other groups will receive.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahre-kord University of Medical Sciences
Street address
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2019-07-03, 1398/04/12
Ethics committee reference number
IR.SKUMS.REC.1398.253
Health conditions studied
1
Description of health condition studied
Headache
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache
Primary outcomes
1
Description
Headache rate measured by AVS.
Timepoint
The amount of pain will be measured and recorded by VAS 0, 15, 30, 45 and 60 minutes after the start of treatment by the patient.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, in addition to painkillers, oxygen therapy will be started by Non-rebreather mask, the amount of oxygen consumed will be at least 15 liters. The amount of pain will be measured and recorded by VAS 0, 15, 30, 45 and 60 minutes after the start of treatment by the patient.
Category
Treatment - Devices
2
Description
Control group: Routine headache treatment will be started for all patients. This treatment will be done with Ketorolac 30 mg ampoules. Each patient will be asked to rate their pain with a visual analog scale (VAS). After recording the pain, the patient's blood pressure will be measured and recorded, and the O2 sat will be recorded before and after treatment. Also, for the control group, in addition to routine treatment, a mask connected to the air conditioner will be given.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Kashani Hospital in Shahrekord