The effectiveness of aromatherapy massage using Rosa damascena oil on the severity of pain caused by primary dysmenorrhea in students
Design
A phase 3, randomized, controlled clinical trial with two parallel groups will be conducted on 104 individuals with primary dysmenorrhea. Randomized blocks of 4 will be created using a random number table.
Settings and conduct
Female Pharmacy and Dentistry students of Zanjan University of Medical Sciences will massage one mg of Rosa damascena oil on the skin of the suprapubic area three times a day for 10 minutes for three consecutive menstrual cycles. This treatment will begin the day before menstruation and continue for three days after. We will not be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Students aged 18 to 35 years, regular menstruation, primary dysmenorrhea level 1 to 2 according to the Multidimensional Verbal Scoring System, usual sense of smell, and ability to smell fragrances.
Exclusion criteria: Allergy to Rosa damascena, suspected pregnancy, use of hormonal contraceptives, use of analgesics other than mefenamic acid, abnormal uterine bleeding, and secondary dysmenorrhea.
Intervention groups
Control group: Routine treatment including taking 500 mg mefenamic acid capsules every 6 hours for the first three days of menstruation
Intervention group: Massage one mg of Rosa damascena oil, three times a day for 10 minutes on the skin of the suprapubic area two days before the onset of menstruation to three days after it
Main outcome variables
Menstrual pain intensity; menstrual pain duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250226064865N1
Registration date:2025-03-15, 1403/12/25
Registration timing:prospective
Last update:2025-03-15, 1403/12/25
Update count:0
Registration date
2025-03-15, 1403/12/25
Registrant information
Name
Samineh Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 3635
Email address
jafari_s@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-04, 1404/01/15
Expected recruitment end date
2025-12-06, 1404/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of aromatherapy massage using Rosa damascena oil on the severity of pain caused by primary dysmenorrhea in students
Public title
The effectiveness of aromatherapy massage using Rosa damascena oil on the severity of pain caused by primary dysmenorrhea in students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Regular menstruation
Primary dysmenorrhea, grade 1 to 2, based on the Verbal Multidimensional Scoring System
Having a normal sense of smell and ability to smell perfumes
Willingness to participate in the study
Exclusion criteria:
Allergy to Rosa damascena
Suspected pregnancy
Use of hormonal contraceptives
The use of other pain relievers except mefenamic acid
History of abnormal uterine bleeding
Having chronic pelvic inflammatory disease
Having systemic diseases
secondary dysmenorrhea
History of pelvic or abdominal surgery
Having an ovarian cyst
Congenital anomalies of the genital tract
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals will be selected by convenience sampling and then allocated to the intervention and control groups using a 4-block random sampling method.
For this purpose, the 26 blocks of four will be selected using a random number table, resulting in a sample size of 52 individuals per group. Blocking will be performed by a person not involved in the sampling.
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 committee of Zanjan University of Medical Sciences
Street address
Blvd. of Ostad Saboti, Zanjan University of Medical Sciences,Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2025-01-20, 1403/11/01
Ethics committee reference number
IR.ZUMS.REC.1403.284
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
The severity of menstrual pain
Timepoint
In three time periods: 8-13, 13-18 and 18-24 per day for three consecutive cycles
Method of measurement
Visual analog scale
2
Description
Duration of menstrual pain
Timepoint
In three time periods: 8-13, 13-18 and 18-24 per day for three consecutive cycles
Method of measurement
Total number of hours of pain per cycle
Secondary outcomes
1
Description
The need to use drug therapy to reduce pain
Timepoint
The end of each menstrual cycle for three consecutive months
Method of measurement
The number of capsules of mefenamic acid consumed
Intervention groups
1
Description
The intervention group will massage one cc of Rosa damascena Barij essential oil topically onto the pubic for 10 minutes, three times a day, starting two days before the start of menstruation and ending three days after. The massage will be done with the palm of one hand in a back-and-forth motion without additional pressure.
Category
Treatment - Drugs
2
Description
The control group will receive routine treatment, which includes 500 mg of mefenamic acid capsules from the onset of menstrual symptoms until 3 days after.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Pharmacy, Zanjan University of Medical Sciences
Full name of responsible person
Samineh Jafari
Street address
Professor Sobuti Boulevard ,Next to Ayatollah Mousavi Hospital, Faculty of Pharmacy,Zanjan , Iran
City
Zanjan
Province
Zanjan
Postal code
56184- 45139
Phone
+98 24 3347 3635
Fax
+98 24 3347 3637
Email
pharmacy@zums.ac.ir
Web page address
https://pharmacy.zums.ac.ir/
2
Recruitment center
Name of recruitment center
School of Dentistry, Zanjan University of Medical Sciences
Full name of responsible person
Samineh Jafari
Street address
Professor Sobuti Boulevard ,Next to Ayatollah Mousavi Hospital, Faculty of Dentistry,Zanjan , Iran