Comparative investigation between the effectiveness of aromatherapy with Lavandula angustifolia with counselling based on Mindfulness-based Cognitive Therapy for sexuality (MBCT-S) on the sexual function of married women in reproductive age
Comparative investigation between the effectiveness of aromatherapy with Lavandula angustifolia and counselling based on Mindfulness-based Cognitive Therapy for sexuality (MBCT-S) on the sexual function of married women in reproductive age
Design
A clinical trial consisting of two intervention groups and a control group, with parallel groups, on 60 married women. Random allocation software is used for randomization.
Settings and conduct
Aromatherapy group: daily use of lavender essential oil
Sexual counseling group with mindfulness-based cognitive therapy approach: 8 sessions of group counselling
Participants/Inclusion and exclusion criteria
Inclusion criteria :Women 18-49 years ,Married ,Being sexually active
Exclusion criteria :Happening of major stress during 3 month ago, Smelling disorder, Pregnancy, Sensitivity to lavender essential oil, Digestive disorders, Absence of the spouse
Intervention groups
1. Aromatherapy group: 2-3 drops of lavender essential oil are poured daily on a napkin daily and inhaled from a distance of 20 cm.
2. Sexual counseling group with mindfulness-based cognitive therapy approach: In 8 sessions of 120 minutes (one session per week), they will receive group sexual counseling with mindfulness-based cognitive therapy approach.
3. Control group: no intervention.
Main outcome variables
The rate of sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034452N14
Registration date:2022-03-02, 1400/12/11
Registration timing:registered_while_recruiting
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-08-05, 1401/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation between the effectiveness of aromatherapy with Lavandula angustifolia with counselling based on Mindfulness-based Cognitive Therapy for sexuality (MBCT-S) on the sexual function of married women in reproductive age
Public title
Comparative investigation between the effectiveness of aromatherapy with Lavandula angustifolia with counselling based on Mindfulness-based Cognitive Therapy for sexuality (MBCT-S) on the sexual function of married women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married
Being sexually active
18-45 years old women
Exclusion criteria:
happening of major stress during 3 months before intervention
smelling disorders before intervention
being pregnant before intervention
Sensitivity to lavender essential oil before intervention
Digestive disorders such as nausea, vomiting, stomachache and nausea before the intervention
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling will be simple accident, In this way, the list of women of reproductive age will be obtained through the SIB system and will be contacted randomly. How to randomize using online software to generate random sequences(www.randomizer.org).
To randomize the selection, Participants will be assigned a number from 1 to 60 respectively, Then using the block random allocation method With six blocks of ten, People will be divided into three groups of 20.In order to hide the random allocation process and avoid selective bias ,this action after preparing the final list and will be done by someone other than the principal investigator and the researcher will be obliged to act exactly accordingly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Kerman University Of Medical Sciences
Street address
Medical Science, Medical University Campus, Haft Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-12-15, 1400/09/24
Ethics committee reference number
IR.KMU.REC.1400.544
Health conditions studied
1
Description of health condition studied
Women with sexual dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of sexual function
Timepoint
To assess the level of sexual function, in two stages, once before the intervention and once immediately after the intervention, the questionnaire (FSFI) is completed by the participants of all three groups.
Method of measurement
Female Sexual Function Index (FSFI)-Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:1. Treatment with lavender aroma : Standard lavender essential oil is purchased from Kashan Drug Pharmaceutical Company and after packaging in dark colored glasses containing 10 cc of essential oil is provided to the patient. The aromatherapy group daily pours 2-3 drops of lavender essential oil on a napkin daily and inhales from a distance of 20 cm.
Category
Treatment - Drugs
2
Description
Intervention group2:. Sexual counseling group with mindfulness-based cognitive therapy approach: Participants in 8 sessions of 120 minutes (one session per week) will receive group sexual counseling with mindfulness-based cognitive therapy approach.Counseling will be provided by a trained researcher.The number of participants in each session will be a maximum of ten people in accordance with health protocols.Due to the global prevalence of Covid-19 disease, if the prevalence of this disease is high at the time of intervention, counseling will be done virtually.
Category
Behavior
3
Description
Control group: .The third group, as a control group, will not receive any intervention other than the routine interventions of the health center. In order to comply with the ethical principles, all the contents of the counseling sessions will be provided to all members of the control group in the form of an educational booklet after the end of the research, and will be referred to counseling centers or gynecologists to investigate the problem.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Roodan city health centers
Full name of responsible person
Zahra teimori ghotb
Street address
Rudan city health center,Velayat stree, Shohada boulevard,Rudan city
City
Rudan
Province
Hormozgan
Postal code
7991743385
Phone
+98 76 4288 7179
Fax
+98 76 4288 3982
Email
Salamatkh.rudan@gmail.com
Web page address
http://rnhn.hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefe Ahmadi
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
international@kmu.ac.ir
Web page address
http://www.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zahra Teimori Ghotb
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
zahra.teimori66@gmail.com
Web page address
http://www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefe Ahmadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
a.ahmadi@kmu.ac.ir
Web page address
http://www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefe Ahmadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
a.ahmadi@kmu.ac.ir
Web page address
http://www.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
eople working in academic institutions
Under which criteria data/document could be used
with permission of the main authors and including their names in the new research
From where data/document is obtainable
atefeahmadi59@gmail.com
What processes are involved for a request to access data/document