Determining the effect of rose essential oil on sexual dysfunction and quality of life in postmenopausal women
Design
This study is a double-blind randomized clinical trial on 90 postmenopausal women. in this study, the placebo was made in the same shape, size, and color as the main drug, so the triple-blind method will be used. The intervention is in the form of medication or placebo for 8 weeks and daily consumption of two capsules.
Settings and conduct
This study will be performed on women referring to the health centers of Tabriz University of Medical Sciences. Made in the same shape and synchronously with the drug for placebo blinding. The random allocation method will be used for groups and opaque envelopes will be used to hide random allocation in numbered consecutive packets.
Participants/Inclusion and exclusion criteria
Women with normal menopause,
Being between 45 and 65 years old, married, at least one year old and up to 5 since menopause
Do not use any medication that affects a person's sexual response, including hormonal, herbal, or complementary medications to relieve menopausal symptoms.
Reluctance to continue participating in research
Do not take medication or placebo for more than 6 days during the study
Use of other treatment and intervention methods to reduce menopausal symptoms during research other than the instructions provided by the researcher
The occurrence of unfortunate events such as loss of spouse or close relatives during the research period
Intervention groups
Intervention group: Rose essential oil in the form of soft capsules containing 15 mg
Control group: placebo with a similar appearance and containing only sesame oil or soybean oil
Main outcome variables
Overall sexual function score; Overall quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190818044553N1
Registration date:2020-07-22, 1399/05/01
Registration timing:prospective
Last update:2020-07-22, 1399/05/01
Update count:0
Registration date
2020-07-22, 1399/05/01
Registrant information
Name
Rana Dousti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 7654
Email address
rana.doosty2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rose oil essence on the sexual dysfunction of menopaused women
Public title
The effect of rose oil essence on the sexual dysfunction of menopaused women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with normal menopause,
Being between 45 and 65 years old,
married,
at least one year old and up to 5 since menopause
Do not use any medication that affects a person's sexual response, including hormonal, herbal or complementary medications to relieve menopausal symptoms.
No known mental health problems or systemic illness affecting sexual function
Do not take any sedatives or antidepressants, aspirin or anticoagulants Lack of sensitivity to herbal medicines
Absence of digestive disorders such as nausea, vomiting, nausea and vomiting
No addiction or smoking
having a minimum literacy in order to complete the questionnaire
No accidents at least in the last 6 months
Exclusion criteria:
Creating any sensitivity to the essential oils used in this research
Occurrence of any disease during this study that interferes with the results of this study.
Reluctance to continue participating in research
Do not take medication or placebo for more than 6 days during the study
Use of other treatment and intervention methods to reduce menopausal symptoms during research other than the instructions provided by the researcher
Occurrence of traumatic events such as loss of spouse or close relatives during the research period
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The selected samples will be randomly assigned using a computer random number table through blocks of 4 and 6 to receive the desired treatment in both groups of soft capsules, red and placebo, and will be assigned according to the assigned group. On closed opaque envelopes, which will be written by a person not involved in the selection of research subjects and data collection, consecutive numbers will be written by the same person in accordance with the assigned group of glasses containing the group of soft red capsules and placebo It will be placed inside the envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Rose essential oil is available in soft capsules containing 15 mg of essential oil (standardized based on the presence of at least 7.5 mg of citronellol in each soft capsule) based on sesame oil or soybean oil. The placebo will have a similar appearance and only contain sesame or soybean oil, so that the samples and the service provider, the researcher is unaware of the contents of the capsules, and the researcher analyzing the results of the analysis will be unaware of the allocation of individuals in groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz, Azadi St., Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, Third Floor, Research Deputy
City
tabriz
Province
East Azarbaijan
Postal code
00984113357311
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.TBZMED.REC.1399.342
Health conditions studied
1
Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
sexual function
Timepoint
before and 4 weeks after intervention, 8 weeks after intervention
Method of measurement
Female Sexual Function Index Questionnaire
2
Description
Quality of Life
Timepoint
Before and 4 weeks after intervention, 8 weeks after intervention
Method of measurement
Menopause Quality Of Life Questionnaire ( MENQOL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Soft capsules containing 15 mg of essential oil (standardized based on the presence of at least 7.5 mg of citronellol in each soft capsule) based on sesame oil or soybean oil twice daily oral for 8 weeks. Made in the laboratory of the Faculty of Medicine, Tabriz University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: Placebo with similar appearance and containing only sesame oil or soybean oil
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Community Health Centers of Tabriz
Full name of responsible person
Rana Dousti
Street address
Tabriz's Community Health Centers
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Email
rana.doosty2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rana Dousti
Position
PHD Student Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5155884818
Phone
98 41365706391
Email
rana.doosty2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rana Dousti
Position
Phd Student Midwfery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5155884818
Phone
98 41365706391
Email
rana.doosty2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rana Dousti
Position
Phd Student Midwfery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
rana.doosty2@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
The results of the clinical study will be published in the form of an article
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use with reference to the article
From where data/document is obtainable
Rana dousti Email
What processes are involved for a request to access data/document