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Comparative study of the effect of hypnotherapy and Monstrogol capsule on primary dysmenorrhea

Protocol summary

Study aim
Comparative study of the effect of hypnotherapy and Monstrogol capsule on primary dysmenorrhea in girls living in dormitories of Isfahan University of Medical Science in 2022
Design
The clinical trial has two groups of control and intervention, double-blind, randomized, on 72 patients with 36 people in each group. This randomization will be done by minimization software.
Settings and conduct
People with primary dysmenorrhea are randomly divided into control and intervention groups by minimazaition software. The control group receives the monstrog capsule in the dormitory and the intervention group in the obstetrics clinic, which has been prepared for the research, undergoes hypnotherapy by the researcher. This research is double-blind because the questioner and the analyzer are unaware of the grouping of people and identify people with a code.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Conscious consent to participate in research Single students living in dormitories Suffering age 25-18 years Having regular menstrual periods Having primary dysmenorrhea for at least two previous consecutive periods No application of complementary medicine methods during the last two months
Intervention groups
Hypnotherapy in the intervention group will be performed to evaluate its effectiveness on the severity of primary dysmenorrhea pain, bleeding volume and number of days of pain. Monstrogel capsules in the control group will be evaluated to evaluate its effectiveness on the severity of primary dysmenorrhea pain, bleeding volume and number of days of pain.
Main outcome variables
Pain score, Number of days of pain and Bleeding volume

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220203053922N1
Registration date: 2022-03-19, 1400/12/28
Registration timing: prospective

Last update: 2022-03-19, 1400/12/28
Update count: 0
Registration date
2022-03-19, 1400/12/28
Registrant information
Name
Mina Navabi Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4522 2688
Email address
navabi2170@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of hypnotherapy and Monstrogol capsule on primary dysmenorrhea
Public title
Comparative study of the effect of hypnotherapy and Monstrogol capsule on primary dysmenorrhea in girls living in dormitories of Isfahan University of Medical Science in 2022
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent to participate in research Single students living in dormitories Suffering age 25-18 years Having regular menstrual periods Having primary dysmenorrhea for at least two consecutive previous periods No application of complementary medicine methods during the last two months Painful menstruation in most menstrual cycles with a pain score of at least 4 out of 10 according to the Visual Analogue Scale (VAS) during two periodic periods Hypnosis of people
Exclusion criteria:
Any known disease of the genital tract Secondary dysmenorrhea History of abdominal or pelvic surgery Endometriosis Tobacco use (cigarettes, hookah and drugs), alcohol Speech, hearing, and mental problems Heart, kidney, respiratory, diabetes, asthma, hypothyroidism or hyperthyroidism, epilepsy and other patients in need of medication Sudden weight loss Special diet (vegetarian) Do professional exercise and intense physical exercises Use of herbs, traditional and complementary medicine during the last two months Psychological problems and diseases requiring medication (bipolar disorder, psychosis, major depression, obsession, borderline disorders, dependent personality disorder, schizoid personality disorder, paranoid personality disorder) based on self-reported research units Having coagulation disorders and taking anticoagulants Existence of depression in the individual based on the score obtained from the DASS21 questionnaire
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, sample selection and random assignment in two groups using Minimization software will be used; In this way, the list of people is entered into the software by coding and people are randomly selected by the software, and are placed in two groups of test and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research will be a double-blind clinical trial (because the analyzer and the questioner will be unaware of which group the people are in) and the collection of information and random allocation of samples using Minimization software, so this study, two Group (test and control group) is three-stage and multivariate. The questioner is not aware of the grouping of individuals when recording information and results, and the analyzer is not aware of the grouping of individuals when analyzing data, and individuals are examined by specific codes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
22 plack, No. 4 West, Narvan st, Shahed blvd
City
Shahin Shahr
Province
Isfehan
Postal code
8319918292
Approval date
2022-01-31, 1400/11/11
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.203

Health conditions studied

1

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

Primary outcomes

1

Description
Pain score
Timepoint
Before. Immediately and two months after the intervention
Method of measurement
Pain ruler

2

Description
Number of pain days
Timepoint
Before. Immediately and two months after the intervention
Method of measurement
Asking the patient

3

Description
Bleeding volume
Timepoint
Before. Immediately and two months after the intervention
Method of measurement
PBLAC chart

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Hypnotherapy. Hypnotherapy will be performed in three sessions of 20 minutes for the experimental group individually.In the first session, hypnotherapy is introduced as a safe and uncomplicated medical treatment and also indoctrination test is performed. At the end of the first session, a light ecstasy and simple relaxation are given to the subjects.In the second session, various techniques are used to enter the trance, and following the involuntary closing of the eyes, inductions related to muscle relaxation and deepening techniques will be performed, and analgesia will begin. In the hypnosis phase, conditioning is done and they learn how to be able to anesthetize their desired areas. In the third session, trance practice and self-hypnotherapy will be performed and more deepening techniques will be used and people will be conditioned to fall into ecstasy when hearing dysmenorrhea by listening to the researcher's instincts and immediately anesthetize their desired points. After these steps, with the onset of dysmenorrhea, the subjects will be able to enter the trance and begin analgesia by listening to the researcher's hypnotherapy.
Category
Treatment - Other

2

Description
Control group: Menstrog capsule. Monstrogol (dry extract of saffron stigma, anise and celery) is a herbal capsule that has the effect of reducing menstrual pain and has an effect on smooth muscle contraction and has anti-inflammatory properties. This capsule contains 1/4 mg of dry extract powder of saffron stigma, 1/60 mg of dry extract powder of anise fruit and 1/16 mg of dry extract powder of celery. The amount of drug is 2.8-2.2 microliters of total essential oil and 3.1-1 microliters of anethole in each capsule. People in the control group of Monstrogol drug produced by Gol Daroo Company take one capsule every 8 hours for 3 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dormitory of Isfahan University of Medical Sciences
Full name of responsible person
Ms. Maryam Masoudi
Street address
Hezar Jerib st.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
muiac@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Hezar Jerib st.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mahboobeh Valiani
Position
Associate Professor, Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hezar Jerib st.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Mahboobehvaliani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mehdi Fathi
Position
Associate Professor of Cardiac Anesthesia
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Danesh va Salamat Town, between Shahid Javan and Al-Shahidi Squares, Shahid Fakoori Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
mandala_110@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Navabi Zadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Narvan st
City
Shahin Shahr
Province
Isfehan
Postal code
8319918292
Phone
+98 31 4522 2688
Email
navabi2170@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of information of the subjects
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
Yes - There is 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
Title and more details about the data/document
Comparative study of the effect of hypnotherapy and Monstrogol capsule on primary dysmenorrhea in girls living in dormitories of Isfahan University of Medical Science in 2022
When the data will become available and for how long
12 Months
To whom data/document is available
Researcher
Under which criteria data/document could be used
If the subjects agree
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document
Contact the researcher by phone and email
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