The purpose of this study is to examine the effect of Viola odorata oil nasal drop on elderly sleep quality. This clinical trial, includes two groups and is single blinded. In this study, 60 elderly people with poor sleep quality were studied in three Sabzevarer centers in 1395. Inclusion criteria include: Not suffering from mental illness; Respiratory diseases and Musculoskeletal pains and Exclusion criteria include: Discontinue use of Viola odorata oil for any reason and eny allergic reaction during the study. At first Petersburg's Sleep Quality Measurement Questionnaire was completed by the researcher for eligible individuals and the elderly people with a sleep score of at least 5 were put on the name list. Then the names were divided into two groups of intervention (violet oil) and placebo (paraffin oil) with the coin toss method. The method of doing the work was practically done by the researcher for both groups. In the intervention group, two drops of violet oil were dropped by a researcher with a dropper in each nostril of the elderly, and then the elder was asked to explain the method. This work was done half an hour before bedtime by the elder for one month and the questionnaire was completed in three steps before, 15 days and one month after the beginning of the study and at the end of each week, a follow up was conducted. All steps in the placebo group were also performed, but paraffin oil was used instead of violet oil.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082229470N1
Registration date:2017-11-03, 1396/08/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-03, 1396/08/12
Registrant information
Name
Malihe Sadat Hejazyan
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51444663522
Email address
hejazyanm93@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences, College of Nursing
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Viola odorata oil nasal drop on elderly sleep quality
Public title
The Effect of Viola odorata drop on elderly sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to Cooperation; Older people over the age of 60; Not suffering from mental illness such as severe depression; Drug abuse; Other diseases such as Parkinson and Alzheimer; Respiratory diseases; Musculoskeletal pains; Having a score higher than 5 in the Petersburg Sleep Quality Questionnaire. Exclusion criteria: Discontinue use of Viola odorata oil for any reason; Consumption of Viola odorata by the client contrary to the prescribed dose; Any allergic reaction to Viola odorata oil during the study.
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Sabzevar University of Medical Sciences
Street address
Pardise, Tohid street, Sabzevar
City
sabzevar
Postal code
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
ir.medsab.rec.1395.76
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
sleep quality
Timepoint
The questionnaire was completed in three steps before, 15 days and one month after the beginning of the study.
In the intervention group, each night, half an hour before bedtime, two drops of violet oil from the Tooba company were dropped in each nostril for one month.
Category
Treatment - Other
2
Description
In the placebo group, each night, half an hour before bedtime, two drops of paraffin oil were dropped in each nostril for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Retirement center
Full name of responsible person
malihe Hejazyan
Street address
Sabzevar
City
Sabzevar
2
Recruitment center
Name of recruitment center
Old people's home
Full name of responsible person
malihe Hejazyan
Street address
sabzevar
City
Sabzevar
3
Recruitment center
Name of recruitment center
Health Center
Full name of responsible person
malihe Hejazyan
Street address
Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohammad Mohammadzade
Street address
Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Malihe Hejazyan
Position
MSc Student of Geriatric Nursing
Other areas of specialty/work
Street address
College of Nursing, Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4466 3522
Fax
Email
malihehejaziyan237@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Javad Ganjlo
Position
Faculty member of Medical Surgical Nursing group,MSc of Nursing
Other areas of specialty/work
Street address
College of Nursing, Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51444446070
Fax
Email
jganj@yahoo.com
Web page address
www.medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Malihe Hejazyan
Position
MSc Student of Geriatric Nursing
Other areas of specialty/work
Street address
College of Nursing, Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4466 3522
Fax
Email
malihehejaziyan237@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)