Determine the effect of aromatherapy on sleep quality, fatigue and anxiety in patients with MS
Design
In the control group, one hour before bed, the sweet almond extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the cloth by a pin) And smell for 5-10 minutes.
Settings and conduct
Clinical trial with control group, Blind, randomized, with 60 patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 50 years; informed consent, EDSS Expanded Disability Status Scale that measures the severity of MS patient disability less or equal to 4 .
Exclusion criteria: use of hypnotic and antipyretic drugs, use of other complementary and alternative methods during the study,History of asthma or respiratory diseases, History of smoking
Intervention groups
In the intervention group, one hour before bedtime, the lavender extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the clothes by a pin) And smell for 5-10 minutes.
Main outcome variables
Quality of sleep; fatigue; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038211N8
Registration date:2019-04-26, 1398/02/06
Registration timing:registered_while_recruiting
Last update:2019-04-26, 1398/02/06
Update count:0
Registration date
2019-04-26, 1398/02/06
Registrant information
Name
Fahime Davodabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 7610
Email address
F_davodabady@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of aromatherapy with lavender on sleep quality, fatigue and anxiety in patients with Multiple sclerosis
Public title
Aromatherapy Effects on Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with MS who have Expanded Disability Status Scale (EDSS) equal or less than 4.
Patients with MS aged 18 to 50 years old
Informed consent
Exclusion criteria:
Use of other complementary and alternative methods during the study
Sleeping and sedative medications, antidepressants and analgesics during the study
History of asthma or respiratory diseases
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are entered with accessible method in the study. Blocks randomly divide into intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals with entry criteria are divided into intervention and control groups according to the random numbers table. One of the groups is A and the other is called B. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the Classification of the groups. Data analysis is also done by someone who is unaware of the allocation of groups. The control group also receive similar (but not effective) intervention so containers containing essential oils are of a single form and color, so are unaware of the allocation to the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.ARAKMU.REC.1397.196
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Sleep quality with Pittsburgh Sleep Quality Questionnaire
Timepoint
Measurement of sleep quality at the beginning of the study and the end of the fourth week after the intervention began
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Fatigue with Fatigue Impact Scale MS
Timepoint
Measurement of fatigue at the beginning of the study and the end of the fourth week after the intervention began
Method of measurement
Fatigue Impact Scale MS
3
Description
Anxiety with State-Trait Anxiety Inventory (STAI)
Timepoint
Measurement of anxiety at the beginning of the study and the end of the fourth week after the intervention began
Method of measurement
State-Trait Anxiety Inventory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one hour before bedtime, the lavender extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the clothes by a pin) And smell for 5-10 minutes.
Category
Treatment - Other
2
Description
Control group: one hour before bed, the sweet almond extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the cloth by a pin) And smell for 5-10 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Association of Arak
Full name of responsible person
Fahimeh Davodabady
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
fahimedavodabady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
fahimedavodabady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
Fahimedavodabady@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 34173505
Email
fahimedavodabady@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD