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Comparison of aromatherapeutic effect of Jasmine and Clary sage oils on sexual dysfunction of women of reproductive age

Protocol summary

Study aim
Comparison of aromatherapeutic effect of Jasmine and Clary sage oils on Sexual dysfunction of women of reproductive age in Rafsanjan, 1400
Design
A randimized controlled clinical trial with parallel groups, three blinded
Settings and conduct
Sampling will be done from Health Center No. 1 in Rafsanjan. Oils are received from the company under the letters B, A and C. Samples, researcher and statistical consultant of oil type will be unaware. Sexual function score is measured before the intervention, if it is less than 28, the person is included in the study and is randomly placed in one of 4 groups. If you are in the intervention and placebo groups, oil is given to the sample for aromatherapy and after 6 weeks, 4 groups complete the questionnaire again.
Participants/Inclusion and exclusion criteria
Entry: Iranian nationality, Monogamy, range of reproductive ages, sexual dysfunction, having at least once in Vaginal intercourse week. No entry: pregnancy and Breastfeeding, use of any drug affecting the sexual response, use of drugs in the couple, mental problems or systemic diseases known to affect sexual function in the couple, olfactory and other nasal disorders, gastrointestinal disorders such as nausea, vomiting Following the inhalation of different scents, obvious and important interpersonal problems between husband and wife, history of allergy to the studied oils, obvious vaginal infection
Intervention groups
The intervention groups of Jasmine, Clary sage oil and placebo group applied 2 drops of sweet Almond oil 2 times a day, 2 times a day (morning after waking up and night before going to bed) on the back of the upper lip (under the nose) and refuse to wash their face for at least 20 minutes. This process continues for 6 weeks and the control group does not receive any intervention.
Main outcome variables
Status of sexual dysfunction with aromatherapy of Jasmine and Clary sage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160308026971N13
Registration date: 2022-01-29, 1400/11/09
Registration timing: prospective

Last update: 2022-01-29, 1400/11/09
Update count: 0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of aromatherapeutic effect of Jasmine and Clary sage oils on sexual dysfunction of women of reproductive age
Public title
Comparison of the effect of aromatherapy with Jasmine and Clary sage oils on sexual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality Monogamy Be in the range of reproductive ages (15 to 45 years) Existence of sexual dysfunction (according to the score obtained from the questionnaire, score less than 28) Having vaginal sex at least once a week
Exclusion criteria:
Pregnancy and Breastfeeding Use of any drug that affects a person's sexual response Drug use in couples Existence of known psychological problems or systemic diseases affecting sexual function in the couple according to the individual (cardiovascular disease, diabetes, lower urinary tract symptoms, rheumatoid arthritis, urinary incontinence, anxiety, obsession and depression) Existence of olfactory disturbance and other disorders related to the nose according to the individual Existence of digestive disorders such as nausea, vomiting following inhalation of various odors Existence of obvious and important interpersonal problems between husband and wife, according to the wife History of allergies to the studied oils Existence of obvious vaginal infection according to the person's own statement
Age
From 15 years old to 45 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: 168
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are assigned randomly using a random number table, and used to hide consecutive opaque envelopes numbered from 1 to 168. After random allocation, eligible individuals will be placed in one of four groups of aromatherapy with Jasmine, Clary sage, placebo (Sweet almond) or control.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The oils under study are blinded by the company and delivered with the letters B, A and C by the research team and given to women of Reproductive age by a researcher or colleague. Questionnaires and checklists with codes C, B, A and D will be provided to participants. The completed questionnaires will be provided to the statistical consultant for analysis and thus the participants, researcher, colleague and statistical consultant are unaware of the type of oil and the study will be of the three blind type.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
No. 7, Alley 11, Kargar Ave
City
Rafsanjan
Province
Kerman
Postal code
7716857685
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.RUMS.REC.1400.229

Health conditions studied

1

Description of health condition studied
Sexual disorder
ICD-10 code
F66
ICD-10 code description
Other sexual disorders

Primary outcomes

1

Description
Sexual dysfunction score
Timepoint
Before the intervention, the end of the intervention
Method of measurement
Female Sexual Function Index (FSFI) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: 2 drops 2 times a day on the back of the upper lip (under the nose) as an aromatherapy of Clary sage oil 45% with sweet almond oil base for 6 weeks, prepared from the shoot (steam distillation of buds and leaves Plant) by Bain-marie method, made by Dr. Oil Company of Isfahan.
Category
Treatment - Drugs

2

Description
Second intervention group: 2 drops 2 times a day on the back of the upper lip (under the nose) as an aromatherapy of jasmine flower oil 50% with sweet almond oil base for 6 weeks, prepared from the plant flower by Bain-marie method, made by Dr. Oil Company of Isfahan.
Category
Treatment - Drugs

3

Description
Third intervention group (placebo): 2 drops 2 times a day on theback of the upper lip (under the nose) as an aromatherapy of sweet almond oil for 6 weeks, prepared from the brain (squeezing and oiling) by cold press method, made by Dr. Oil Company of Isfahan.
Category
Treatment - Drugs

4

Description
Control group: Failure to receive intervention. Complete the questionnaire twice 6 weeks apart.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health services center No. 1 of Rafsanjan city
Full name of responsible person
Zahra Hajabdollahi
Street address
No. 7, Alley 11, Kargar Ave
City
Rafsanjan
Province
Kerman
Postal code
7716857685
Phone
+98 936 584 7355
Email
z.hajabdollahi22@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Street address
Central Organization of Rafsanjan University of Medical Sciences and Health Services, Vice Chancellor for Research and Technology, Imam Ali Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nurse St., Faculty of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Email
marzeyehloripoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nurse St., Faculty of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Email
marzeyehloripoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nurse St., Faculty of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Email
marzeyehloripoor@yahoo.com

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
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