Protocol summary

Study aim
the effect of lavender essential oil on the sleep quality of the elderly
Design
The elderly are randomly assigned to the control and intervention groups based on a random number table.
Settings and conduct
Elderly Examination Group take 2 drops of lavender in the test group every night for 4 weeks.Then 4 weeks after the intervention, the assessment of sleep quality is measured by the assessor.The place of study was Ghaemshahr city.
Participants/Inclusion and exclusion criteria
Criteria for entering the study, over 60 years of age, having a healthy sense of smell, having no history of allergic rhinitis and known respiratory problems . Exit criteria include: physical and mental illnesses, drug use, tobacco and alcohol.
Intervention groups
Both groups (intervention and control) were performed. For the intervention group, lavender and paraffin were used for the control group.
Main outcome variables
sleep quality of the elderly

General information

Reason for update
Acronym
اثر اسطوخودوس بر خواب سالمندان
IRCT registration information
IRCT registration number: IRCT20110906007494N28
Registration date: 2018-10-11, 1397/07/19
Registration timing: retrospective

Last update: 2018-10-11, 1397/07/19
Update count: 0
Registration date
2018-10-11, 1397/07/19
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Student Research Committee of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with essential oils of lavender on sleep quality in the elderly
Public title
The effect of aromatherapy with essential oils of lavender on sleep quality in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
over 60 years of age having a healthy sense of smell having no history of allergic rhinitis and known respiratory problems such as asthma
Exclusion criteria:
physical or mental illness drug use, tobacco and alcoho cognitive impairment and speech impairment
Age
From 60 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was based on a random number table.
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 Mazandaran University of Medical Sciences
Street address
sari-Juibar tree way
City
sari
Province
Mazandaran
Postal code
481578-33971
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
95-356

Health conditions studied

1

Description of health condition studied
sleep disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Lavender effect on elderly sleep quality
Timepoint
4 weeks after the intervention
Method of measurement
Pittsburgh Quality Index

2

Description
sleep disorder
Timepoint
4 weeks after the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Elderly take 2 drops of lavender in the test group every night for 4 weeks
Category
Lifestyle

2

Description
In the control group, placebo (paraffin solution) is used.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Daily aging care centers
Full name of responsible person
Leila Meskini
Street address
Guibar tree way,Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
mes136259@yahoo.com

2

Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Mehdi Rostami
Street address
Guibar tree way,Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1986
Email
mehdirostami1049@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
College Student Research Committee
Street address
Deputy of Research of Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
48157-33971
Email
mehdirostami1049@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bagheri Nasami
Position
Ph.D. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3379 5508
Fax
Email
mes136259@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
Nursing Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nasibe Sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3379 5508
Fax
Email
anna3043@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
phd nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3336 1985
Fax
Email
mes136259@yahoo.com
Web page address

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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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