This study is a single-blind clinical randomized controlled trial to determine the effect of aromatherapy on sleep quality and life satisfaction in elders by using the Pittsburgh Sleep Quality and Satisfaction with Life Questionnaire. Inclusion criteria: Elderly men 60 years and older, elderly men referred to Monempour Health Center of Tabriz, The relative independence in daily activities due to the high score of 20 by Barthel Scale, Good health of smell, having mental health.
Exclusion criteria: Having allergic rhinitis, eczema, Respiratory problems such as asthma known, removing participants from the study intervention, if they forget do intervention more than three times.
The sample size n = 40 for each group have been calculated. The intervention group will receive aromatherapy as 2 drop of pure lavender essence on a prepared cotton ball and inhale from 3-5 cm distance from nose for 20 minutes during 2 weeks, an hour before routine bedtime and then the cotton ball will be connected to the collar and after waking up will be separated and discarded. The control group will not receive any intervention. Participants will follow up by phone. Questionnaire for all two groups, will be completed by the research assistant after2 weeks. The research assistant will be blind and unaware of the study groups and purpose. The most important outcome of this study is to promote the quality of sleep and life satisfaction in elders.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020119919N2
Registration date:2016-02-03, 1394/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Arefeh Davoodi Bavil Oliaii
Name of organization / entity
Nursing and Midwifery of Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
adavoodi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Depurty for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-01-15, 1394/10/25
Expected recruitment end date
2016-04-14, 1395/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on sleep quality and satisfaction with life of elderies
Public title
Sleep quality and satisfaction of life in eldery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Elderly men 60 years and older, Elderly men referred to Monempour Health Center of Tabriz, The relative independence in daily activities due to the high score of 20 by Barthel Scale, Good health of smell, Having mental health.
Exclusion criteria: Having allergic rhinitis, eczema, Respiratory problems such as asthma known, Removing participants from the study intervention, If they forget do intervention more than three times.
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
central Is Not Registered in Any
Secondary trial Id
No Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
South Shariety St; Faculty of Nursing and Midwifery- Tabriz, East Azarbayjan Iran, Islamic Republic Of
City
Tabriz
Postal code
Approval date
2016-01-09, 1394/10/19
Ethics committee reference number
11602/4/5
Health conditions studied
1
Description of health condition studied
sleep quality and life satisfacton
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
sleep quality
Timepoint
End of 14 nights
Method of measurement
pittsburg scale
Secondary outcomes
1
Description
life satisfaction
Timepoint
End of 14 nights
Method of measurement
Diener satisfaction of life scale
Intervention groups
1
Description
Intervention Group 2 weeks (14 nights) and how it works is that every night one hour before bedtime routine, pure lavender essential oils with dropper 2 drops on a cotton ball prepared, and dropped from 3 -5 cm through the nose for 20 minutes, and then the cotton ball with pin 14 nights inhalation elderly elderly and attached to the collar after waking up from the collar is removed and discarded. In control group, do their routine life and do not receive any intervention.
Category
Other
2
Description
In control group was not intervention performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
sevda sadeghpoor
Street address
Shariety South St ; Faculty of Nursing & Midwifery
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Rashidi
Street address
Deputy of Medical Sciences University of Tabriz,Tabriz, Est Azarbayjan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
sevda sadeghpoor
Position
Nursing student of MS/ Nurse
Other areas of specialty/work
Street address
South Shariety St; Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+41 34772699
Fax
Email
sevdasadr71@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculity of Nursing& Midwifery
Full name of responsible person
arefeh davoodi
Position
Master of nursing
Other areas of specialty/work
Street address
South Shariety St; Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+41 34772699
Fax
Email
arefehdavoodi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arefeh davoodi
Position
Master of nursing- Faculty member
Other areas of specialty/work
Street address
Shariety South St ; Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+41 34796969
Fax
Email
arefehdavoodi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)