Effect of cognitive-behavioral group counseling with lavender scent versus placebo on the sleep quality of postmenopausal women with sleep disorder: a single-blind randomized clinical trial
To assess the effect of cognitive-behavioral group counseling with lavender scent versus placebo on the sleep quality of postmenopausal women with sleep disorder
Design
This is a single-blind randomized clinical trial with control group, phase III, in which 136 patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Comprehensive Health Centers on 136 eligible postmenopausal women with sleep disorder. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 50 to 75 years; Being menopausal; Sleep disorder; Being literate
Exclusion criteria:
Olfactory disorder; Mental disorder; Drug use or smoking
Intervention groups
Intervention group:
Cognitive-behavioral group counseling for 60 to 90 minutes weekly for 8 weeks (including sleep mechanism training and its stages, sleep and wake cycles and the underlying factors, relaxation training, sleep hygiene training, prevention of daily naps, problem solving skills, cycle of thought and feeling and behavior) in addition to dripping 3 drops of lavender essential oil on a cotton ball and placing it under the pillow every night for a month
Control group:
Cognitive-behavioral group counseling for 60 to 90 minutes weekly for 8 weeks (including sleep mechanism training and its stages, sleep and wake cycles and the underlying factors, relaxation training, sleep hygiene training, prevention of daily naps, problem solving skills, cycle of thought and feeling and behavior) in addition to dripping 3 drops of placebo on a cotton ball and placing it under the pillow every night for a month
Main outcome variables
Primary outcome:
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N446
Registration date:2022-11-21, 1401/08/30
Registration timing:prospective
Last update:2022-11-21, 1401/08/30
Update count:0
Registration date
2022-11-21, 1401/08/30
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cognitive-behavioral group counseling with lavender scent versus placebo on the sleep quality of postmenopausal women with sleep disorder: a single-blind randomized clinical trial
Public title
Effect of cognitive-behavioral group counseling with lavender scent versus placebo on the sleep quality of postmenopausal women with sleep disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50 to 75 years
Being menopausal
Sleep disorder
Being literate
Exclusion criteria:
Olfactory disorder
Mental disorder
Drug use or smoking
Age
From 50 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. Thus, the trial will be run as single-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-08-12, 1401/05/21
Ethics committee reference number
IR.UMSHA.REC.1401.591
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
F51.8
ICD-10 code description
Other sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Using the Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral group counseling for 60 to 90 minutes weekly for 8 weeks (including sleep mechanism training and its stages, sleep and wake cycles and the underlying factors, relaxation training, sleep hygiene training, prevention of daily naps, problem solving skills, cycle of thought and feeling and behavior) in addition to dripping 3 drops of lavender essential oil on a cotton ball and placing it under the pillow every night for a month
Category
Treatment - Drugs
2
Description
Control group: Cognitive-behavioral group counseling for 60 to 90 minutes weekly for 8 weeks (including sleep mechanism training and its stages, sleep and wake cycles and the underlying factors, relaxation training, sleep hygiene training, prevention of daily naps, problem solving skills, cycle of thought and feeling and behavior) in addition to dripping 3 drops of placebo on a cotton ball and placing it under the pillow every night for a month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers
Full name of responsible person
Arezoo Shayan
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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