Protocol summary

Study aim
Evaluation the effect of citrus aurantium on severity of primary dysmenorrhea in two models of skin massage and inhalation aromatherapy
Design
This study is a four-group experimental clinical trial with two control groups and two intervention groups. In each group, 35 people are randomly selected and no blinding is performed. severity of pain will be assessed before and after the intervention in the first and second cycles.
Settings and conduct
The data collection place is the dormitories of Zanjan University of Medical Sciences. In confirmation of having dysmenorrhea, individuals will be randomly assigned in two intervention groups (citrus aurantium essential oil) and two control groups (almond oil).
Participants/Inclusion and exclusion criteria
Satisfaction to participate in the study, regular menstrual cycle with a duration of 3-7 days and interval of 21-35 days, menarche before the age of 18, primary dysmenorrhea with a score of 5 or more in VAS in two consecutive cycles, age 18-25 years, single, Iranian, lack of mental or physical illness, absence of gynecological disease , having a normal sense of smell exclusion criteria: Unwillingness to continue attending the study, very severe dysmenorrhea, incidence of dysmenorrhea after the age of 20, allergy to citrus aurantium essential oil, diagnosis of physical or mental illness during the study, abnormal bleeding during the study
Intervention groups
In the intervention group, people will receive abdominal massage and inhalation of citrus aurantium, and in the control group, people will receive abdominal massage and inhalation of sweet almond oil. Both types of intervention will be performed in the first two days of the menstrual cycle for two consecutive cycles.
Main outcome variables
Reduce the severity of menstrual pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120414009463N62
Registration date: 2021-02-18, 1399/11/30
Registration timing: registered_while_recruiting

Last update: 2021-02-18, 1399/11/30
Update count: 0
Registration date
2021-02-18, 1399/11/30
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-14, 1399/11/26
Expected recruitment end date
2021-06-23, 1400/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effect of citrus aurantium on severity of primary dysmenorrhea in two models of skin massage and inhalation aromatherapy
Public title
evaluation the effect of citrus aurantium on severity of primary dysmenorrhea in two models of skin massage and inhalation aromatherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
satisfaction to participate in the study having a regular menstrual cycle with a duration of 3-7 days and interval of 21-35 days menarche before the age of 18 primary dysmenorrhea with a score of 5 or more in the visual Analogue scale During two consecutive cycles age 18-25 years single Iranian lack of mental or physical illness absence of gynecological disease (myoma, endometriosis, ovarian cyst, pelvic inflammatory disease, etc.) having a normal sense of smell
Exclusion criteria:
Unwillingness to continue attending the study very severe dysmenorrhea incidence of dysmenorrhea after the age of 20 allergy to citrus aurantium essential oil diagnosis of physical or mental illness during the study abnormal bleeding during the study
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done with the consecutive presence of the researcher in the dormitories of Zanjan University of Medical Sciences in two stages. At first two dormitories of Zanjan University of Medical Sciences will be divided into two groups of massage therapy and inhalation aromatherapy with using of lottery card . Then in the first stage, people who have dysmenorrhea and met inclusion criteria and want to participate in the study will be determined, and then They will be randomly assigned to the intervention and control group within each dormitory. Randomization will be done by using the website Randomization with www.graphpad.com. Initially, inside each dormitory, people who met inclusion criteria were given the number one to 70, and with using web-based randomization will placed in two groups of massage therapy with citrus aurantium essential oil and massage with sweet almond oil, and in the another dormitory in two groups of inhalation aromatherapy of citrus aurantium essential oil and sweet almond oil. The number B is written on the bottles of almond oil and the number A is written on the bottle containing of citrus aurantium essential oil.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of tehran university of medical science
Street address
Keshavarz Boulevard, corner of Quds Street, central building
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-01-02, 1399/10/13
Ethics committee reference number
IR.TUMS.FNM.REC.1399.201

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea

Primary outcomes

1

Description
Percentage of people whose menstrual pain intensity has decreased after abdominal massage of citrus aurantium oil or inhalation of citrus aurantium essential oil.
Timepoint
Before the intervention, after the intervention in the first cycle and after the intervention in the second cycle in the control and intervention groups.
Method of measurement
visual analogue scale tool

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the study who met the inclusion criteria in the In massage group, massage will be done in the first two days of the menstrual cycle daily for 30 minutes with 2cc of citrus aurantium essential oil for two consecutive cycles and In the aromatherapy group, in the first two days of the menstrual cycle for two consecutive cycles, 10 drops of citrus aurantium essential oil are sprayed on the piece of cotton and inhaled at a distance of 20 cm from the nose for 30 minutes.
Category
Treatment - Drugs

2

Description
Control group: Participants in the study who met the inclusion criteria in the In massage group, massage will be done in the first two days of the menstrual cycle daily for 30 minutes with 2cc of sweet almond oil for two consecutive cycles and In the aromatherapy group, in the first two days of the menstrual cycle for two consecutive cycles, 10 drops of sweet almond oil are sprayed on the piece of cotton and inhaled at a distance of 20 cm from the nose for 30 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dormitories of Zanjan University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Street address
Tehran, Enghelab Square, 16 Azar St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6105 4227
Email
z.bayat1995sb@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammad ali sahraeian
Street address
Tehran, Enghelab Square, 16 Azar St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Behboodi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
معاونت پژوهشی دانشگاه علوم پزشکی تهران
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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Behboodi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Behboodi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Behboodi@tums.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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