The effect of aromatherapy with Rosa damascene essential oil on the sleep quality of the elderly
Design
A quasi-experimental before and after study will be performed on 35 elderly people with using convenient sampling-based in Rasht nursing home
Settings and conduct
The instruments used in the study are demographic information questionnaire and PSQI. After completing the questionnaire, the essential oil of Rosa damascene is used. Thus, every night one hour before the normal bedtime, for 10 nights, 5 drops of 10% Rosa damascene essential oil is dropped with a dropper on a pre-prepared cotton ball 3-5 cm away through the nose and is inhaled for 20 minutes. Then the same cotton ball is attached to the elderly collar after being put inside a piece of cloth with a pin and is thrown away after waking up. At the end of the tenth day, the sleep quality of the elderly will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 60 years and older; willingness to participate in the study and to give informed consent to perform it; residing in the nursing home; the ability to answer the questionnaire questions; any history of allergy to Rosa damascene or its compounds; using the herbal tea or extract of Rosa damascene; asthma and sensitivity to essential oils according to the patient report and health record at the center.
Exclusion criteria: any disease during the study period; which leads to prohibition of using of Rosa damascene extract; including allergic rhinitis, eczema; known respiratory problems; excluding the participant from the study in case of forgetting the intervention more than three times; showing any allergic reaction to Rosa damascene during the study.
Intervention groups
Rosa damascene,10%, 5 drops, 10 nights
Main outcome variables
Sleep quality of the elderly
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190805044438N1
Registration date:2019-11-13, 1398/08/22
Registration timing:registered_while_recruiting
Last update:2019-11-13, 1398/08/22
Update count:0
Registration date
2019-11-13, 1398/08/22
Registrant information
Name
Roya Mansour-ghanaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4256 5058
Email address
r_ghanaei@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of aromatherapy with Rosa damascene essential oil on the sleep quality of the elderly in nursing homes
Public title
The effect of aromatherapy with Rosa damascene essential oil on the sleep quality of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly 60 years and older
Willingness to participate in the study and to give informed consent to perform it
Residing in the nursing home
The ability to answer the questionnaire questions
Exclusion criteria:
Any history of allergy to Rosa damascene or its compounds
Using the herbal tea or extract of Rosa damascene
Asthma and sensitivity to essential oils according to the patient report and health record at the center
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Langeroud School of Nursing and Midwifery, Martyr Yaghoub Sheikhi St. leyla kooh, Langeroud, Guilan
City
Langeroud
Province
Guilan
Postal code
4477163485
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.GUMS.REC.1398.383
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
sleep quality (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction)
Timepoint
Before intervention - 10 days after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rosa damascene, 10%, 5 drops, for 10 nights, Rosa damascene essential oil is dropped with a dropper on a pre-prepared cotton ball 3-5 cm away through the nose and is inhaled for 20 minutes. Then the same cotton ball is attached to the elderly collar after being put inside a piece of cloth with a pin and is thrown away after waking up.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Old people's home in Rasht
Full name of responsible person
Roya Mansour-ghanaei
Street address
Langeroud School of Nursing and Midwifery, Martyr Yaghoub Sheikhi St. leyla kooh, Langeroud, Guilan, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5059
Email
r_ghanaei@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shademan Nemati
Street address
Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
4477163485
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
r_ghanaei@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour Ghanaei
Position
instructor, faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Langeroud School of Nursing and Midwifery, Martyr Yaghoub Sheikhi St. leyla kooh, Langeroud, Guilan
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5059
Email
r_ghanaei@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour Ghanaei
Position
instructor, faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Langeroud School of Nursing and Midwifery, Martyr Yaghoub Sheikhi St. leyla kooh, Langeroud, Guilan