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comparison of aromatherapy with Citrus aurantium and lavender on sexual satisfaction of lactating women referred to health care centers

Protocol summary

Study aim
Determine the effect of aromatherapy with Citrus aurantium and lavender on the sexual satisfaction of lactating women
Design
This randomized triple-blind clinical trial study was performed on 210 qualified lactating woman referred to health care centers of Kermanshah. Participants were randomly assigned to three groups (70 in each group) including two interventional and one control group with a placebo and each participant is assigned a code.
Settings and conduct
Place of study is health care centers of Kermanshah and participants receive three times a day and each time,inhaled 2 to 3 drops of essence(lavender or Citrus aurantium ) or placebo solution that are poured on forearm area of the hand for 40 days.Study is triple-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Placing in breastfeeding(3-6 months postpartum), lack of psychological problemsorsystemic disease known to affect sex performance, lack of sexual problems in husband according wife's comment, absence of stressful events in the last 6 months, having a health record in health care centers, married and living with apermanent husband, use a reliable method of contraception,lack of using any medication that has an effect on sexual response, lack of disorder of olfactory or sensitivity to herbal medicines. Exclusion criteria: quitting the study, occurrence of side effects of medication and sensitivity to essential oils during the study, occurrence of major emotional event, occurrence of pregnancy during the study,occurrence of mental health problems or serious illness during the study, divorce or death or illness of the husband during the study.
Intervention groups
Intervention group 1: intervention with Lavender aroma Intervention group 2: intervention with Citrus aurantium aroma Intervention group 3: intervention with placebo (control group)
Main outcome variables
The main outcome is the mean of total sexual satisfaction after intervention in study groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160427027633N3
Registration date: 2017-12-17, 1396/09/26
Registration timing: registered_while_recruiting

Last update: 2017-12-17, 1396/09/26
Update count: 0
Registration date
2017-12-17, 1396/09/26
Registrant information
Name
Foruzan Sharifipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
f.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-12-24, 1395/10/04
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of aromatherapy with Citrus aurantium and lavender on sexual satisfaction of lactating women referred to health care centers
Public title
comparison of aromatherapy with Citrus aurantium and lavender on sexual satisfaction of lactating women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in the study having health dossier in health care centers literacy sufficient to complete of the questionnaire married and lives with her husband permanently use a reliable method of contraception exposure during lactation (6-3 months postpartum) lack of mental health problems or known systemic disease affecting a person's sexual function lack of drug dependence lack of sexual problems in husband according wife's comment lack of addicted husband the absence of stressful events in the last 6 months (divorce of parents, death of family members, etc.) the absence of diseases, , lack of stress factors (Parent divorce in the past six months), l the lack of any effective drug on a person's sexual response (Antihypertensive drugs, Thiazide Diuretics, Antidepressants, Antihistamines, Barbiturates, Narcotics, Diazepins, Amphetamines, Cocaine) lack of disorder of olfactory or sensitivity to herbal medicines according wife's comment and other disorders related to nose (fracture, deviated septum, rhinitis and sinusitis
Exclusion criteria:
dissuasion of participating in the study incidence of side effects and sensitivity to essential oils during the study emotional major event such as a death of One of the relatives in particular loss of child proof of pregnancy occurrence during the study the incidence of mental health problems or serious illness during the study living away from his husband catching the debilitating diseases such as cancer that person will have to leave the study surgery during the intervention divorce,death or illness of husband during the intervening period of study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 210
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Simple randomization method is used for random allocation (hiding allocation). In this way, 210 cards matched in appearance are prepared and 70 of them have the number or code 1 that specifies the group "Intervention based on essence of Citrus aurantium " and on 70 others of them the number or code 2 which specifies the group "Intervention based on essence of lavender " and on the other 70 Of them, the number or code 3, which specifies the control group, means "routine actions" is written. Then, each eligible person for inclusion in the study randomly takes one of these cards with the codes written on it. In this way, the random allocation of patients to each group is determined without letting the participants to know the nature of the numbers 1, 2, or 3 in the type of intervention that will be assigned.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, to hide the allocation of aromas (essence of Citrus aurantiumor lavender) and placebo (Firouz baby oil) Opaque envelopes sequentially numbered are used.Each envelope contains a glass of essence of Citrus aurantiumor lavender or placebo. Medications were placed on the envelope in the randomized allocation sequence by the person not involved in the study. Investigating individuals to study and delivering envelopes are done by the researcher himself from 1 to 210. Therefore, in this study, participant and researcher blindness are used. Blindness of data analyzer also runs. Thus, individuals in two groups of intervention (Citrus aurantium or lavender) and the placebo group (Firouz babyoil) are characterized by code (for example, codes 1, 2 and 3) and data analyzer is not aware of the subject code. So the study is triple-blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Avenue, Research Deputy of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
KUMS.REC.1396.189

Health conditions studied

1

Description of health condition studied
sexual satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sexual satisfaction
Timepoint
Before and 40 days after the intervention
Method of measurement
Lindaberg's Sexual Satisfaction Questionnaire

Secondary outcomes

1

Description
Side effects
Timepoint
40 days after start the intervention
Method of measurement
Researcher made questionnaire

Intervention groups

1

Description
Interventions 1: intervention with Lavender aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler.
Category
Treatment - Drugs

2

Description
Interventions 2: intervention with Citrus aurantium aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler.
Category
Treatment - Drugs

3

Description
Intervention 3:control with Firuze baby oil aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah City Health Center
Full name of responsible person
fruzan sharifipour
Street address
Shahid Beheshti Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 2987
Email
sharifipour_fr91@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
susan heydarpour
Street address
Dolat Abad, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
sharifipour_fr91@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
School of Nursing and Midwifery
Full name of responsible person
Foruzan Sharifipour
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Street address
Dolat Abad, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Fax
Email
sharifipour_fr91@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Susan heydarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Dolat Abad, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Fax
Email
s.heydarpour1394@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Foruzan sharifipour
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Street address
Dolat Abad, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Fax
Email
sharifipour_fr91@yahoo.com
Web page address

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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