Determination of the Effect of Lavender on Anxiety and Depression in the Elderly
Design
Clinical Trial with community based and control group, with parallel groups without blindness, randomized, follow up immediately after the end of the intervention
Settings and conduct
This study is conducted in elderly people of senior home in Shiraz city
Participants/Inclusion and exclusion criteria
Signing informed consent to participate in research; ability to swallow and not have problems with oral and digestive tract that interfere with oral intake; having the consciousness to complete the questionnaires; depression and anxiety disorders are not due to physical problems such as hypothyroidism.
Intervention groups
In this study, 30 of the intervention group consisted of 5 grams of lavender herbal tea twice in day at morning and night during two weeks, 2 cups of lavender. The control group does not receive any intervention.
Main outcome variables
Depression and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090304001742N4
Registration date:2019-06-15, 1398/03/25
Registration timing:prospective
Last update:2019-06-15, 1398/03/25
Update count:0
Registration date
2019-06-15, 1398/03/25
Registrant information
Name
mohammadrafi bazrafshan
Name of organization / entity
shiraz university medical science
Country
Iran (Islamic Republic of)
Phone
+98 917 382 1959
Email address
mrbazr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lavender herbal tea on Anxiety and Depression in the Elderly
Public title
Effect of Lavender on Anxiety and Depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in research
Ability to swallow and not have problems with oral and digestive tract that interfere with oral intake
Having the consciousness to complete the questionnaires
Depression and anxiety disorders are not due to physical problems such as hypothyroidism
Exclusion criteria:
Were reluctant to stay in the study
Having sensitivity to Lavender
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, Using Excel software, a random sequence of numbers was formed and then randomly, sub-sub groups in the intervention group and above half in the control group were placed.
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 Larestan University of Medical Sciences
Street address
Emam Khomeini square, Velayat blvd.
City
Larestan
Province
Fars
Postal code
74319-75566
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.LARUMS.REC.1398.006
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety
2
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Depression
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Anxiety
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group consists of 5 grams of lavender aerated aerial parts, which is used in 2 roasted meals in the morning and at night, in the form of 2 cups of lavender, in two weeks.
Category
Treatment - Drugs
2
Description
Control group: they are not received any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Nursing Home, Lar
Full name of responsible person
Dr Mohammad rafi Bazrafshan
Street address
Dadman Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 3228 8613
Email
mrbazr@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Karimi
Street address
Emam Khomeini square, Velayat blvd.
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5234 2877
Email
mrbazr@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Dr. Mohammad rafi Bazrafshan
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam khomeini square, velayat blv, postal code 74319-75566
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5225 5278
Email
mrbazr@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Mohammad rafi Bazrafshan
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam khomeini square, Velayat blv, postal code 74319-75566
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5225 5278
Email
mrbazr@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad rafie Bazrafshan
Position
Faculty member-assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam khomeini square, Velayat blv, postal code 74319-75566
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5225 5278
Email
mrbazr@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It can be shared by unidentifiable participants
When the data will become available and for how long
Access begins a year after the publication of results
To whom data/document is available
People who are working in the academic and scientific institutions
Under which criteria data/document could be used
It needs the agreement of Larestan Medical School
From where data/document is obtainable
mohammad rafi bazrafshan, faculty member of larestan medical school, mrbazr@sums.ac.ir, tell phone:07152255278, cell phon number:09173821959
What processes are involved for a request to access data/document
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences