Protocol summary

Study aim
Determining the effect of teaching lifestyle measures of Iranian medicine in premarital counseling centers on increasing marital satisfaction of couples in 1401
Design
The clinical trial with a control group, with parallel groups, without blinding, was divided into two groups of intervention (61 couples) and control (61 couples) using the randomized block method.
Settings and conduct
In this study, which is a clinical trial type, it is conducted on 122 couples who come to Haji Maqsoudi counseling center during three months who are planning to get married and to participate in pre-marriage training courses. After visiting the researcher in person and coordinating with the management of Haji Maghsoudi Comprehensive Health Center, they attended the pre-marriage counseling section and the couples who met the conditions to enter the study were explained by the researcher and the informed consent questionnaire was completed for them. The questionnaires are provided to the participants by trained interviewers and are completed before the study.Two face-to-face training workshops were held one week after the delivery of the training package (two workshops one week apart) and one workshop using the collaborative method (group discussion, question and answer) two weeks apart from the first two workshops.
Participants/Inclusion and exclusion criteria
The condition of the couple's first marriage Obtaining consent to participate in the study
Intervention groups
Intervention group: Intervention group: The educational content for the workshops is prepared after reviewing the reliable sources of Iranian medicine and the articles available in this field and the consensus of opinion among the Iranian medical experts collaborating in the project. Control group: They do not receive any training in the field of Iranian medicine.
Main outcome variables
Marital quality Marital Satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201122049458N1
Registration date: 2023-06-12, 1402/03/22
Registration timing: prospective

Last update: 2023-06-12, 1402/03/22
Update count: 0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
razieh nabimeybodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3223 8916
Email address
r.nabimeybodi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of teaching lifestyle measures of Iranian medicine in premarital counseling centers on the marital satisfaction of couples
Public title
Investigating the effect of teaching lifestyle measures of Iranian medicine on the marital satisfaction of couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The couple's first marriage Obtaining consent to participate in the study
Exclusion criteria:
Failure to participate in training classes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 122
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Dr. Rahnamon Hospital, Yazd (ethics committee in research)
Street address
Farrokhi
City
Yazd
Province
Yazd
Postal code
8913814396
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.SSU.SRH.REC.1401.027

Health conditions studied

1

Description of health condition studied
Marital Satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Marital satisfaction level based on Enrich Marital Satisfaction Questionnaire
Timepoint
The questionnaire is completed before the start of the training and 3 months after the start of the training
Method of measurement
Enrich Marital Satisfaction Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention is carried out on 122 couples who come to Haji Maqsoudi counseling center during three months, who intend to get married and to participate in pre-marriage training courses. The educational content for the workshops is prepared after reviewing the reliable sources of Iranian medicine and the articles available in this field and the consensus of opinion among the Iranian medical experts collaborating in the project, which includes teaching the six principles of maintaining health and a healthy lifestyle from the perspective of Iranian medicine, in In addition, an educational package containing an educational booklet + a video that contains audio-visual training along with the talks of an Iranian medical expert will be delivered to the participants of the project. one week apart) and a workshop using the collaborative method (group discussion, question and answer) will be held two weeks apart from the first two workshops. The maximum capacity of each workshop is 35 couples. The virtual group will remain after the end of the workshop to answer the possible questions of the couples, and the questions about the topics raised will be answered by an Iranian medical expert. Educational content: The six principles of lifestyle, including eating and drinking according to the mood and slowly. Eating and avoiding liquids with meals, sleeping and waking up including the best sleeping hours between 10 pm and 2 am, controlling mental and emotional states, weather conditions according to the person's mood, eliminating waste from the body and eliminating constipation, exercise and rest. According to the person's temperament, educational content: lifestyle factors in Iranian medicine. In this topic, the six lifestyle factors that all humans are exposed to are described under the title "Six Essential Principles for a Healthy Life". The six essential principles are important because all people deal with them on a daily basis and life is impossible without them. The correct management of these cases has been the concern of Iranian traditional medicine scientists for a long time. These six vital principles are: 1. Air and environment 2. Movement and stillness (exercise and rest) 3. Sleep and wakefulness 4. Eating and drinking 5. Disposal of unnecessary materials and preservation of essential materials 6. Pay attention to mental states: the things recommended in this section are taught and applicable to maintain health in healthy people and prevent them from getting sick. 1. Air and environment: One of the most important components of the environment is the air around us. Harmonizing the body with the air in the environment and following its recommendations helps to maintain health. Movement and stillness (exercise and rest): In traditional medicine, movement and stillness are important parts of maintaining health. The best time to exercise is when the weather is mild, so it is around noon in spring, at the beginning of the day in summer, and at the end of the day in winter. But the duration and intensity of exercise should be less in spring and summer, and more in autumn and winter. The time of exercise should be adjusted with the time of eating. Do not exercise when you are hungry because the body needs food in this state. Exercise consumes the same few substances that the body feeds on when it is hungry. You should not exercise immediately after eating, because the digestion of food is not yet complete and the entry of undigested food into the organs will harm the body. It is better that before exercise, the body is cleansed of inappropriate substances and the intestines and bladder are empty of urine and feces. Athletes should not eat heavy or slow-digesting foods two hours before the start of training or competition. 3. Sleep and wakefulness: In traditional medicine, a good sleep in a healthy person has certain conditions, some of which are different in different ages, seasons and temperaments according to the amount of humidity. Therefore, children sleep more than adults, women sleep more than men, and the elderly sleep less. And in winter, due to increasing coldness and humidity, sleep becomes longer. The best sleep duration is 6-10 hours. Of course, the period mentioned is for adults and children and babies need to sleep more than 10 hours a day. Young people need more sleep than old people. From a scientific point of view, the best time to sleep is from early night to early morning (between morning call to prayer and sunrise). This dream gives you vitality and energy. 4. Eating and drinking: Each of the different foods has its own quality and mood. This problem causes the type of food consumed by people to affect their physical and mental characteristics. Food recommendations are expressed with different approaches in traditional medicine. Fast-digesting foods are mostly recommended for people who do not have strong digestion due to illness or who have recently recovered from illness. Examples of these foods include: grilled chicken, chicken soup with well-cooked wheat bread. Slow-digesting foods are suitable for those who do heavy physical activities, such as athletes, farmers, construction workers, and blacksmiths. Because if these people use fast-digesting food, it will quickly decay and they have to use their body's internal energy. Examples of these foods are: hard-boiled or half-boiled eggs, halim, meat, halwa prepared with oil, flour, starch, honey, or sugar, etc. It is better for sedentary people such as students, employees, etc. Managers should not use the above foods. General food recommendations: correct eating habits from the perspective of traditional medicine: 1. To help the proper digestion of food in the digestive system, do not eat before feeling real hunger (honest appetite) and stop eating before feeling full. 2. Observe moderation in eating. That is, don't eat so much that it causes stomach heaviness, discomfort, nausea, etc., and don't eat so little that it causes weakness and loss of body strength.3. Observing the order of eating food and avoiding mixing food is one of the instructions to maintain health. Fast-digesting foods should not be consumed after slow-digesting foods. For example, the habit of eating salad or soup after a meal is very wrong and should be stopped gradually. Preferably eat the salad before the main meal or as a snack. 4. Preferably do not use drinks with food. 5. Take small bites. 6. Chew food well (chew each small bite at least 15 times) 7. Create a calm and cheerful environment while eating and don't eat when angry. 8. Eat calmly and slowly and don't talk while eating. 9. While eating, do not occupy your mind with miscellaneous issues (watching TV, listening to music, reading, etc.). 10. Do not eat food too hot or too cold. 11. Do not eat while standing or moving. 12. Do not exercise or heavy activity immediately after eating. 13. Avoid eating fruit or drinks immediately after meals. 14. Avoid sleeping immediately after eating. 5. Disposing of unnecessary substances from the body and maintaining essential substances in the body: Cleansing the body of toxins and waste substances that are created in the body during the digestion process plays an important role in maintaining human health. Also, maintaining vital and essential substances in the body is important for health. If a person eats enough food but does not have enough stool, urine or sweating, sooner or later he will have a problem. Also, if a person eats enough food but has too much feces, urine or sweat, he will soon have problems. 6. Mental states: The mental state affects all aspects of people's lives. Their effect on the body is faster than the previous 5. To maintain peace and remove mental tensions and emotions, it is useful to follow the following recommendations: Hearts are calmed by the remembrance of God. Strengthen your spiritual relationship with God through worship and prayers and trust him in problems and difficulties. Do not suppress your emotions and emotions and share them with relatives and friends. Laugh at the right time and cry at the right time. Do not be ashamed of crying and do not suppress it.
Category
Lifestyle

2

Description
Control group: They do not receive any training in the field of Iranian medicine.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Haji Maqsoodi Counseling Center
Full name of responsible person
Monire Seyed Hashemi
Street address
Safaiye, Imam Javad square
City
yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3838 0923
Email
m.seiedhashemi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Razie Nabi Meybodi
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Razie Nabi Meybodi
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Imam Khomeini Street, Faculty of Traditional Medicine
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3223 8916
Email
r.nabimeybodi@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Monire Seyed Hashemi
Position
specialist
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Farrokhi Street, Shahid Rahnamoun Hospital
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3312 2002
Email
m.sesiedhashemi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Monire Seyed Hashemi
Position
specialist
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Farrokhi Street, Shahid Rahnamoun Hospital
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3312 2002
Email
m.seiedhashemi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be publicly available
Under which criteria data/document could be used
The data will be publicly available
From where data/document is obtainable
Dr.Monire Seyed Hashemi m.seiedhashemi@yahoo.com
What processes are involved for a request to access data/document
After submitting the application, the documents will be sent in less than a month
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