Determining the effect of rose oil on insomnia and sleep quality of students living in the girls' dormitory of Ahvaz Jundi Shapur University of Medical Sciences.
Design
After obtaining written consent and random allocation, people are divided into two groups A and B using a random table. Then the prepared demographic checklists are completed. The absence of anxiety and depression of students is checked with the Beck Depression and Anxiety Questionnaire before the intervention. Then, the amount and presence of insomnia will be determined with the Pittsburgh Questionnaire.
Rose oil and placebo oil will be made by the pharmacist and both rose oil and placebo will be coded (A, B). Necessary information will be given to students through face-to-face training by the researcher, as well as information sheets. Students in both groups are asked to massage the bottle containing 3 to 5 drops of oil on their forehead for a week and once a day before going to sleep. Finally, in order to measure the level of insomnia of the students after the intervention, at the end of the restudy, the Petzberg questionnaire will be completed by the researcher of the unit.
Settings and conduct
Rose oil and placebo oil will be made by the pharmacist and both rose oil and placebo will be coded (A, B). Necessary information will be given to students through face-to-face training by the researcher, as well as information sheets. Students in both groups are asked to massage the bottle containing 3 to 5 drops of oil on their forehead for a week and once a day before going to sleep.
Participants/Inclusion and exclusion criteria
1. A female student living in the dormitory
Intervention groups
40 recipients of rose oil
Main outcome variables
insomnia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221227056938N3
Registration date:2023-08-10, 1402/05/19
Registration timing:prospective
Last update:2023-08-10, 1402/05/19
Update count:0
Registration date
2023-08-10, 1402/05/19
Registrant information
Name
Fatemeh Razavinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 210 3403
Email address
fatemehrazavinia15@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rose oil on insomnia and sleep quality of students living in the girls' dormitory
Public title
Investigating the effect of rose oil on insomnia and sleep quality of students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A female student living in the dormitory
Iranian
Having a sleep disorder and insomnia with the Pittsburgh Questionnaire
Willingness to participate in the study
Exclusion criteria:
Having a specific disease including depression, anxiety and migraine headaches
Taking drugs affecting sleep in the last two weeks, such as sleeping pills
Allergy to rose
A person's refusal to continue participating in the study
Age
From 18 years old to 36 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation, people are divided into two groups A and B using a random table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Rose oil and placebo oil will be made by the pharmacist and both rose oil and placebo will be coded (A, B). For the preparation of medicines, 40 bottles with rose oil from the company and another 40 bottles will be prepared by the placebo substance and will be filled with the same color and shape as rose oil. Roses prepared from Attari are put in olive oil at a ratio of 4 times olive oil to roses for 48 hours in a greenhouse, then strained and this is done 3 times. Also, the placebo is paraffin oil, we grease the wall of the paraffin oil can with 5ppm of rose essential oil. Study at the patient level, the outcome evaluator and the statistical analyst of the results will be blinded. Before being filled, the drug and placebo bottles are divided into two equal groups of 40 numbers based on the random number table in the blocky method, and then based on the results obtained, the bottles are filled with drug essence or placebo. Only the researcher can decipher the contents of each bottle based on the initial form of the randomization results. The research unit and the researcher will not be aware of the type of medicine in the Kedar bottles. Finally, the researcher will deliver the coded drugs to the students and give them the necessary training on how to use them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Committee of Jundishapur University of Medical Sciences, Ahvaz
Street address
Ahvaz, academic city, next to the central organization of Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz, Vice-Chancellor of Research and Technology Development
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2023-04-10, 1402/01/21
Ethics committee reference number
IR.AJUMS.REC.1402.249
Health conditions studied
1
Description of health condition studied
insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia
Primary outcomes
1
Description
Insomnia or lack of sleep is a symptom that a person does not fall asleep continuously. In other words, difficulty in falling asleep, waking up repeatedly during the night with inability or difficulty in falling asleep again, waking up very early in the morning and sleep that does not rejuvenate are called insomnia.
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving rose oil .. Rose oil and placebo oil will be made by the pharmacist and both rose oil and placebo will be coded (A, B). For the preparation of medicines, 40 bottles will be filled with rose oil. Roses prepared from Attari in olive oil at a ratio of 4 times olive oil to roses are placed in a greenhouse for 48 hours, then strained and this is done 3 times. Massage 5 drops on your forehead once a day before going to bed for a week.
Category
Treatment - Drugs
2
Description
Control group: another 40 bottles will be prepared by the placebo substance and will be filled with the same color and shape with rose oil. The placebo is paraffin oil, we grease the wall of the paraffin oil can with 5ppm of rose essential oil. Massage the bottle containing 3 to 5 drops of oil on your forehead once a day before going to bed for a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls' dormitory of Jundishapur University of Medical Sciences, Ahvaz
Full name of responsible person
Fatemeh Razavinia
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 911 210 3403
Email
fatemehrazavinia15@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naghmeh Yazdi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 311 9228
Email
naghmehyazdi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
60
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
Ahvaz University of Medical Sciences
Full name of responsible person
Naghmeh Yazdi
Position
asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
karegar
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 311 9228
Email
naghmehyazdi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naghmeh Yazdi
Position
Asistant profesor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 311 9228
Email
naghmehyazdi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Razavinia
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 911 210 3403
Email
fatemehrazavinia15@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
It is published as an article.
When the data will become available and for how long
After completing the study
To whom data/document is available
all people
Under which criteria data/document could be used
article
From where data/document is obtainable
Correspond
What processes are involved for a request to access data/document