A clinical trial for comparing the effect of aromatherapy with Lavender essential oil with Acetaminophen tablet 325 mg in treatment of headache in patient receiving Nitroglycerine infusion.
In this clinical trial study with aim to compare the effect of aromatherapy with Lavender essential oil with Acetaminophen tablet 325 mg in treatment of headache in patient receiving Nitroglycerine infusion, 135 patients receiving Nitroglycerine infusion will be selected with available sampling method and then randomly allocated in tree groups (Lavender essential oil, Acetaminophen tablet and placebo). Randomization will be performed by choosing sealed envelopes containing different treatment protocols. Inclusion criteria: Age between 18 to 65; Written consent to participate in research; The ability to speak Persian; No record of Allergic Rhinitis; No record of respiratory problems; Not using analgesic drugs before admission; Having no headache; No diagnosed psychiatric disorder; Being aware of time, place and subject; No record of olfactory dysfunction; No addiction; Having a maximum score of 31 based on Spielberger State-anxiety questionnaires score. Exclusion criteria: Patient unwillingness to participate in the research; Use analgesics drugs; Sensitivity to lavender aroma. The intensity and quality of headache will be measured based on visual analogue scale and modify short form McGill pain questionnaire, Before and 15, 30 and 60 minutes after the intervention. Once the headache is started, in the Lavender essential oil group, subjects will inhale Lavender essential oil by smeared with a cotton filled by 3 drops of Lavender essential oil for 30 minutes, in the Acetaminophen tablet group, one 325 mg tablet will be used orally and in the placebo group, liquid paraffin will be used for the same time period
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015033121569N1
Registration date:2015-07-15, 1394/04/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-15, 1394/04/24
Registrant information
Name
Ehsan Eshghi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 5031
Email address
eshghie901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences.
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial for comparing the effect of aromatherapy with Lavender essential oil with Acetaminophen tablet 325 mg in treatment of headache in patient receiving Nitroglycerine infusion.
Public title
The effect of Lavender essential oil in treatment of headache.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 65; Written consent to participate in research; The ability to speak Persian; No record of Allergic Rhinitis; No record of respiratory problems; Not using analgesic drugs before admission; Having no headache; No diagnosed psychiatric disorder; Being aware of time, place and subject; No record of olfactory dysfunction; No addiction; Having a maximum score of 31 based on Spielberger State-anxiety questionnaires score. Exclusion criteria: Patient unwillingness to participate in the research; Use analgesics drugs; Sensitivity to lavender aroma.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be performed by choosing sealed envelopes containing different treatment protocols.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of Mashhad University Of Medical Science
Street address
Research ethics committee, Ghorayshi building, Daneshgah avenue, Mashhad, Iran
City
Mashhad
Postal code
9177899191
Approval date
2014-10-01, 1393/07/09
Ethics committee reference number
930236
Health conditions studied
1
Description of health condition studied
headache
ICD-10 code
G44.1
ICD-10 code description
Vascular headache, not elsewhere classified
Primary outcomes
1
Description
Headache Severity
Timepoint
Before and 15,30 and 60 minutes after intervention
Method of measurement
Visual Analog Scale
2
Description
Headache Quality
Timepoint
Before and 15,30 and 60 minutes after intervention
Method of measurement
Modify Short Form McGill Pain Questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
3 drops of Lavender Essential Oil is inhaled for 30 minutes as soon as headache beginning.
Category
Treatment - Other
2
Description
One 325 mg Acetaminophen tablet is used orally as soon as headache beginning.
Category
Treatment - Drugs
3
Description
3 drops of liquid paraffin is inhaled for 30 minutes as soon as headache beginning.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac emergency department of Mashhad Farabi hospital.