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The effects of aromatherapy with rose oil (Rosa damascena Mill.) inhalation on primary dysmenorrhea: A prospective randomized controlled clinical trial

Protocol summary

Study aim
The primary purpose of our research evaluates hypothesis " the rose oil aromatherapy which added to the standard treatment of primary dysmenorrhea decrease pain scores more than Control Group".
Design
Prospective, parallel group, randomized controlled clinical trial. Forty-three patients in each group and 86 patients in total will be included in the study. The random number generation program of the Microsoft Office Excel program will be used to make randomization sequence.
Settings and conduct
The volunteers will be diveded two group, according to the randomization, as Group Rose (Group R) and Group Control (Group C). All patients in Group C and Group R will use standard analgesics drug (diclofenac sodium 50 mg enteric film tablet) for abdominal pain in the menstrual period. In group R, in addition to standard analgesics drug, rose oil will be given to the volunteers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients who have primary dysmenorrhea, and a painful menstrual period complaint; The patients who are in the ASA I risk group; being in the age range of 18-24 years. Exclusion criteria: The patients who have abnormal menstrual bleeding; allergy to rose oil and analgesic drugs; the history of asthma-like respiratory disease.
Intervention groups
The Rose oil was obtained by distillation method from in Ahi Evran University Faculty of Agriculture in the region of the Kırşehir, Turkey. (Citronellol (%26,14), Nonadecane (%21,32), etc). The dark bottle, containing 2-3 drop rose oil, and odorless tissue paper which has the same trademark and specification will be given to the volunteers. Firstly, the patients, VAS score >4, will use a standard analgesic drug. And then they will evacuate the rose oil in the bottle onto the tissue paper. They will cover on their faces with this tissue and they will sniff him for 15 minutes.
Main outcome variables
The VAS (Visual analog scale) pain score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180324039145N2
Registration date: 2018-09-25, 1397/07/03
Registration timing: prospective

Last update: 2018-09-25, 1397/07/03
Update count: 0
Registration date
2018-09-25, 1397/07/03
Registrant information
Name
Recai Dagli
Name of organization / entity
Ahi Evran University Faculty of Medicine
Country
Turkey
Phone
+90 386 213 45 15
Email address
recai.dagli@ahievran.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-01, 1397/07/09
Expected recruitment end date
2019-10-01, 1398/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of aromatherapy with rose oil (Rosa damascena Mill.) inhalation on primary dysmenorrhea: A prospective randomized controlled clinical trial
Public title
Rose oil aromatherapy treatments for diysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients diagnosed the primary dysmenorrhea have a painful menstrual period complaint in the ASA (American Society of Anesthesiologists) I risk group in the age range of 18-24 years old
Exclusion criteria:
The patients who are constantly using analgesics for other reasons The patients who are treated for any upper respiratory tract disease that may cause edema in the nasal mucosa and may prevent smelling The patients who have anosmia diagnosed by otorhinolaryngologists The patients who have abnormal menstrual bleeding The patients who have allergies to rose oil and analgesic drugs, the asthma-like respiratory disease
Age
From 18 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
The random number generation program of the Microsoft Office Excel program will be used to make randomization sequence. The cards named Group Rose (Group R) and Group Control (Group K) will be used to conceal the randomization sequence. The method of concealment will be closed envelopes. 86 blocks will be used for randomization.
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
Clinical Investigations Ethics Committee, the Ahi Evran University
Street address
No.100, Bagbasi St., Kirsehir, Turkey
City
Kirsehir
Postal code
40100
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
2018-10/95

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
Visuel analog scale (VAS) pain scores
Timepoint
Before and after administration in the menstrual period for each patient.
Method of measurement
Visuel analog scale (VAS) (between 1-10 score)

Secondary outcomes

1

Description
analgesic consumption of the patients for twenty-four hours
Timepoint
First twenty-four hours.
Method of measurement
Asking from patients

Intervention groups

1

Description
Intervention group 1 (Group Rose or Group R): The Rose oil will be produced through distillation method at Ahi Evran University Faculty of Agriculture in the region of the Kırşehir, Turkey. The rose oil product used in this study is not licensed in the country. Rose oil product used in this study contains Citronellol (%26,14), Nonadecane (%21,32), Heneicosane (%10,33), Geraniol (%5,08), Methyl Eugenol (%1,46), Ethanol (%0,48), Linalool (%0,12). The dark bottle, containing 2-3 drop rose oil, and odorless tissue paper which has the same trademark and specification will be given to the volunteers. Firstly, the patients will use a standard analgesic drug (diclofenac sodium 50 mg enteric film tablet, max three times a day) (Voltaren, Novartis). And then they will evacuate the rose oil in the bottle onto the tissue paper. They will cover on their faces with this tissue and they will sniff it for 15 minutes (one time).
Category
Treatment - Drugs

2

Description
Intervention group 2 (Group C): The patients with VAS score >4 will use only a standard analgesic drug (diclofenac sodium 50 mg enteric film tablet, maximum three times a day)(Voltaren, Novartis)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Obstetrics and Gynecology, Faculty of Medicine, Ahi Evran University
Full name of responsible person
Selda Songur Dagli
Street address
No.10, Bagbasi St., Kirsehir
City
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
seldasongurdagli@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Obstetrics and Gynecology, Faculty of Medicine, Ahi Evran University
Full name of responsible person
Selda Songur Dagli
Street address
No.100, Bagbasi St., Kirsehir
City
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
seldasongurdagli@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Obstetrics and Gynecology, Faculty of Medicine, Ahi Evran University
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
Faculty of Medicine, Ahi Evran University
Full name of responsible person
Recai Dagli
Position
Ass.Prof.Dr.
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.10, Bagbasi st., Kirsehir
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Fax
Email
recai.dagli@ahievran.edu.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Medicine, Ahi Evran University
Full name of responsible person
Recai Dagli
Position
Ass.Prof.Dr.
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bagbasi street.
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Fax
Email
recai.dagli@ahievran.edu.tr

Person responsible for updating data

Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Faculty of Medicine, Ahi Evran University
Full name of responsible person
Selda Songur Dagli
Position
Ass.Prof.Dr.
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.10, Bagbasi St., Kirsehir
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
seldasongurdagli@hotmail.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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