This clinical trial study was conducted to evaluate the effect of inhaled aromatherapy on lavender severity and frequency of headache during hemodialysis. In this regard, 82 patients were randomly selected from hemodialysis patients who had frequent headache during hemodialysis and were divided into intervention and control groups. The intervention group received lavender extract and the control group received distilled water. Aromatherapy begins after the headache begins during hemodialysis. The severity of headache was measured using visual analogue scale of pain severity, before aromatherapy, 30 minutes and one hour after aromatherapy. Intervention was performed for 4 weeks and data were finally analyzed.
Design
82 patients were randomly divided into intervention and control groups.
Settings and conduct
This study in the hemodialysis section can perform on physicians who have recurrent hemodialysis.
Participants/Inclusion and exclusion criteria
Entry requirements
• Patients 18 years or older
• Voluntary participation in the study
• Having three hemodialysis sessions per week
• No use of perfume and cologne before and during the intervention
• No use of pain medication for 6 hours before intervention
• No respiratory disease
• No problem with the smell
• No sensitivity to aromatherapy
• No drug use
• Earn a score equal to or above 3 on the numeric pain scale.
• Having a history of recurrent hemodialysis headache
Exclusion criteria:
The patient withholds co-operation.
• Problems or illnesses occur during the execution of the plan that prevent the patient from continuing to cooperate.
Intervention groups
People with frequent headaches during hemodialysis.
Main outcome variables
The effect of lavender essential oil inhalation on pain intensity has been investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190718044263N1
Registration date:2019-08-18, 1398/05/27
Registration timing:retrospective
Last update:2019-08-18, 1398/05/27
Update count:0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
zeinab Jamshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5287 5898
Email address
jamshidi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-07-21, 1398/04/30
Trial completion date
2019-07-21, 1398/04/30
Scientific title
The Effect of Inhalation Therapy of Lavender on the severity and times Headaches of Patients During Hemodialysis
Public title
The Effect of Inhalation Therapy of Lavender on the severity and times Headaches of Patients During Hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 years or older
Voluntary participation in the study
Having three hemodialysis sessions per week
No use of perfume and cologne before and during the intervention
• No use of pain medication for 6 hours before intervention
No respiratory disease
No problem with the smell
No sensitivity to aromatherapy
No drug use
Earn a score equal to or above 3 on the numeric pain scale.
Having a history of recurrent hemodialysis headaches
Exclusion criteria:
The patient withholds co-operation.
• Problems or illnesses occur during the execution of the plan that prevent the patient from continuing to cooperate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Actual sample size reached:
82
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample based on statistical formula consisted of 82 patients who were selected based on inclusion criteria and then
They were randomly assigned to intervention and control groups (41 patients in each group) using randomized block design with block size 6 (using table of random permutations). The randomization list is compiled by a statistics expert. In this study, due to the nature of interventions, there is no blinding condition for patients and researchers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur University of Medical Sciences
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.AJUMS.REC.1398.117
Health conditions studied
1
Description of health condition studied
headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Headache
Timepoint
Before the intervention, 30 minutes and one hour after the intervention
Method of measurement
Visual scale measuring pain intensity
Secondary outcomes
1
Description
Frequency of headache
Timepoint
At the end of the intervention
Method of measurement
Count the number of headaches
Intervention groups
1
Description
Intervention group: Inhalation aromatherapy was performed with 2% lavender extract. 3 drops of lavender essential oil is poured onto a cotton pad and the patient inhales for 30 minutes after the headache begins.
Category
Treatment - Drugs
2
Description
Control group: This group uses three drops of distilled water as the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Ward of Golestan Hospital in Ahwaz and Dialysis ward of Shahid Zadeh Behbahan Hospital
Full name of responsible person
Fatemeh Shokripoor
Street address
Golestan
City
Ahwaz and Behbahan
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 5283 5872
Fax
Email
jamshidi.z@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Iraj Nazary
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3311 4149
Email
jamshidi.z@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zeinab Jamshidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
7654327896
Phone
+98 916 336 6712
Email
jamshidi.z@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zeinab Jamshidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 916 336 6712
Email
jamshidi.z@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zeinab Jamshidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
65437865433
Phone
+98 916 336 6712
Fax
Email
jamshidi.z@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available