Investigate the effect of lavender scent on emotion regulation and sleep quality of second grade of elementary school students
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 120 children. The rand function of Excel software is used for randomization.
Settings and conduct
This study is conducted in Semnan second grade elementary schools. Children who score above 41 on the sleep questionnaire are included in the study. They are given unlabeled containers of lavender essential oil or water, so they will not know the contents of the solution
Participants/Inclusion and exclusion criteria
Elementary school children of the second grade, getting a score higher than 41 from the sleep quality questionnaire, not getting sick during the study period, healthy sense of smell of the child (tested with lemon juice), not allergic to herbal medicines.
Intervention groups
Test group: 20 minutes before going to bed, a cotton pad soaked in 3 drops of lavender is placed on the child's collar.
Placebo group: 20 minutes before going to bed, a cotton pad soaked in 3 drops of water is placed on the child's collar.
Main outcome variables
Sleep quality, emotion regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110430006342N16
Registration date:2023-10-25, 1402/08/03
Registration timing:registered_while_recruiting
Last update:2023-10-25, 1402/08/03
Update count:0
Registration date
2023-10-25, 1402/08/03
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of lavender scent on emotion regulation and sleep quality of second grade elementary school students
Public title
effect of lavender scent on emotion regulation and sleep quality of students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The second grade of elementary school children
Exclusion criteria:
getting a score higher than 41 from the sleep quality questionnaire
healthy sense of smell of the child (tested with lemon juice)
not allergic to herbal medicines
Age
From 9 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Each person is placed once in the test group and once in the placebo group
Randomization (investigator's opinion)
Randomized
Randomization description
This study is cross-over. Allocation of samples to test and placebo groups in the first stage is done randomly using RAND of Excel. In this method, the odd number represents group A, who will receive lavender scent first, and the even number represents group B, who will receive placebo first. In this way, group A or B is determined for each person. After finishing the first stage and passing the rest period (washout), the child is placed in the remaining group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Lavender essential oil and water are given to the samples in similar containers without labels
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Semnan University of Medical Sciences
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2023-10-01, 1402/07/09
Ethics committee reference number
IR.SEMUMS.REC.1402.143
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
F51.0
ICD-10 code description
Insomnia not due to a substance or known physiological condition
Primary outcomes
1
Description
Quality of sleep
Timepoint
Before and after intervention
Method of measurement
Child Sleep Habit Questionnaire
2
Description
Emotion regulation
Timepoint
Before and after intervention
Method of measurement
Emotion regulation questionnaire for children and adolescents
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: Every night for two weeks, 20 minutes before going to sleep, a cotton swab dipped in 3 drops of 100% lavender essential oil, which has no label, is attached to the child's neck.
Category
Treatment - Other
2
Description
Control group: For two weeks, every night 20 minutes before going to bed, cotton soaked in 3 drops of water in a container similar to lavender is attached to the child's neck.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools of Semnan province
Full name of responsible person
Tahere Gholami
Street address
Schools of Semnan province
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 919 613 2531
Email
tahereh.gh2531@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3105 2121
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Tahere Gholami
Position
MS. Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
tahereh.gh2531@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3105 2159
Email
aaghods@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3105 2159
Email
aaghods@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome, can be shared
When the data will become available and for how long
The access period will start 6 months after the results are published
To whom data/document is available
University students and faculty members
Under which criteria data/document could be used
Published data is available upon request
From where data/document is obtainable
Ali Asghar Ghods
aaghods@yahoo.com
What processes are involved for a request to access data/document
After the request, the data will be sent one month later