Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000362998
Ethics application status
Approved
Date submitted
6/12/2019
Date registered
13/03/2020
Date last updated
13/03/2020
Date data sharing statement initially provided
13/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of dry figs on primary dysmenorrhea symptoms, perceived stress levels and the quality of life
Scientific title
Examine effects of dried figs on symptoms of primary dysmenorrhea, perceived stress levels and the quality of life during menstrual cycles.
Secondary ID [1] 300032 0
None
Universal Trial Number (UTN)
-
Trial acronym
-
Linked study record
-

Health condition
Health condition(s) or problem(s) studied:
dysmenorrhea 315535 0
pain 315621 0
Condition category
Condition code
Reproductive Health and Childbirth 314560 314560 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized, placebo controlled study. The students in the cinnamon group took 420 gr cinnamon three times a day and the students in the dried fig group took two figs three times a day on the first, second and third days of their three menstrual cycles. The cinnamon group took each cinnamon dose after mixing it in one glass of warm water. The dried fig group took each dose including two figs with one glass of warm water. The placebo group took each placebo dose with one glass of warm water. The total daily cinnamon dose was calculated as 420mg X 3=1260 mg based on the literature. Since there have not been any studies on effects of dried figs on primary dysmenorrhea and since the weight of dried figs corresponding to 1260 mg cinnamon was very low, the daily dose of dried figs providing the same calories as 1260 mg cinnamon was determined. One thousand mg cinnamon is 261 kcal and 1260 mg cinnamon is 329 calories. One thousand mg dried figs have 217 calories. Three-hundred and twenty-nine calories of cinnamon correspond to 152 gr dried figs. In the present study, the dried fig group took six large figs weighing 150 gr in total daily (each is 25 gr). The participants were told to avoid taking painkillers and those taking painkillers were excluded from the study.
Whatsapp group was formed in order to check the intervention compliance of the students whatsapp group was created for each group (cinnamon, placebo and dried fig)
Intervention code [1] 316306 0
Treatment: Other
Comparator / control treatment
The students in the placebo group took placebo three times a day (capsules not containing anything),
Control group
Placebo

Outcomes
Primary outcome [1] 322216 0
Severity of dysmenorrhea was measured with Visual Analogue Scale.
Timepoint [1] 322216 0
-The cycle without intervention (The Visual Analogue Scale used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle without intervention)

-The first cycle with intervention (The Visual Analogue Scale used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle with intervention)

-The second cycle with intervention (The Visual Analogue Scale used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle with intervention)

-The third cycle with intervention (The Visual Analogue Scale used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle with intervention)
Primary outcome [2] 322217 0
Minimum duration of pain of dysmenorrhea was measured with Pain Duration Assessment Form
Timepoint [2] 322217 0
-The cycle without intervention (The Pain Duration Assessment Form used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle without intervention)

-The first cycle with intervention (The Pain Duration Assessment Form used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle with intervention)

-The second cycle with intervention (The Pain Duration Assessment Form used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle with intervention)

-The third cycle with intervention (The Pain Duration Assessment Form used in the study were applied to the participants in the 1st, 2nd, 3rd, 4th, 8th, 16th, 24th, 48th and 72nd hours from the beginning of the cycle with intervention)
Primary outcome [3] 322218 0
Menstrual distress of dysmenorrhea was measured with Menstrual Distress Questionnaire
Timepoint [3] 322218 0
-The cycle without intervention (The Menstrual Distress Questionnaire used in the study were applied to the participants in the 8th hour from the beginning of the cycle without intervention)

-The first cycle with intervention (The Menstrual Distress Questionnaire used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)

-The second cycle with intervention (The Menstrual Distress Questionnaire used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)

-The third cycle with intervention (The Menstrual Distress Questionnaire used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)
Secondary outcome [1] 377761 0
Stress of dysmenorrhea was measured with Perceived Stress Scale
Timepoint [1] 377761 0
-The cycle without intervention (The Perceived Stress Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle without intervention)

-The first cycle with intervention (The Perceived Stress Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)

-The second cycle with intervention (The Perceived Stress Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)

-The third cycle with intervention (The Perceived Stress Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)
Secondary outcome [2] 377762 0
Quality of Life of dysmenorrhea was measured with World Health Organization Quality of Life Scale
Timepoint [2] 377762 0
-The cycle without intervention (The World Health Organization Quality of Life Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle without intervention)

-The first cycle with intervention (The World Health Organization Quality of Life Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)

-The second cycle with intervention (The World Health Organization Quality of Life Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)

-The third cycle with intervention (The World Health Organization Quality of Life Scale used in the study were applied to the participants in the 8th hour from the beginning of the cycle with intervention)

Eligibility
Key inclusion criteria
The students getting a total dysmenorrhea score higher than three.
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Having secondary dysmenorrhea
Not being aged 18-30 years
Having a chronic disease
Having vaginal burning / itching/ discharge or pelvic inflammatory disease
Diagnosis of tumor or fibroma
Not having a body mass index of 19-26
Taking drugs or oral contraceptives for dysmenorrhea
Declining to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/09/2018
Date of last participant enrolment
Anticipated
Actual
2/12/2018
Date of last data collection
Anticipated
Actual
4/03/2019
Sample size
Target
39
Accrual to date
Final
115
Recruitment outside Australia
Country [1] 22172 0
Turkey
State/province [1] 22172 0
Aydin

Funding & Sponsors
Funding source category [1] 304487 0
University
Name [1] 304487 0
The Adnan Menderes University
Country [1] 304487 0
Turkey
Primary sponsor type
Individual
Name
Keziban AMANAK
Address
Faculty of Health Sciences, Midwifery Department, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country
Turkey
Secondary sponsor category [1] 304811 0
None
Name [1] 304811 0
Address [1] 304811 0
Country [1] 304811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304919 0
the ethical committee for clinical research of Health Sciences Faculty at Adnan Menderes University
Ethics committee address [1] 304919 0
Ethics committee country [1] 304919 0
Turkey
Date submitted for ethics approval [1] 304919 0
Approval date [1] 304919 0
23/08/2018
Ethics approval number [1] 304919 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98642 0
Dr Keziban AMANAK
Address 98642 0
Faculty of Health Sciences, Midwifery Department, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country 98642 0
Turkey
Phone 98642 0
+90 2562138866
Fax 98642 0
Email 98642 0
[email protected]
Contact person for public queries
Name 98643 0
Keziban Amanak
Address 98643 0
Faculty of Health Sciences, Midwifery Department, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country 98643 0
Turkey
Phone 98643 0
+90 2562138866
Fax 98643 0
Email 98643 0
[email protected]
Contact person for scientific queries
Name 98644 0
Keziban Amanak
Address 98644 0
Faculty of Health Sciences, Midwifery Department, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country 98644 0
Turkey
Phone 98644 0
+90 2562138866
Fax 98644 0
Email 98644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.