Determining the effect of education based on the theory of planned behavior on promoting reproductive and sexual health of women with endometriosis
Design
Two arm parallel group randomised trial on 76 patients with endometriosis. randomization will performed by quadruple block.
Settings and conduct
Eligible individuals in the infertility clinic of Imam Khomeini Hospital, according to the inclusion criteria, will enter the research. Then, the questionnaires will be completed by two groups. Educational content based on the theory of planned behavior, which has the structures of attitude, abstract norm and perceived control, which is taught in the form of lectures, questions and answers. The control group will receive routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1- Women with endometriosis based on medical tests or medical diagnosis and clinical signs
2- Age between 15 to 45 years
3- Having the ability to read and write
4- No chronic psychiatric disorders (self-reported)
5- Ability to use the Internet and cyberspace
Exclusion criteria:
1- Having genital or reproductive infections at the same time as endometriosis 2- single 3- Not being able to use cyberspace and smart phone
Intervention groups
The intervention group, in addition to get routine activities, 4 training sessions for 120-190 minutes per week for four weeks in the form of educational slides, educational posters, short educational videos compiled by the researcher and educational booklets in PDF format (PDF ) Will be held.
The control group will not receive any intervention
Main outcome variables
sexual & reproductive health
General information
Reason for update
Acronym
PBT
IRCT registration information
IRCT registration number:IRCT20120414009463N64
Registration date:2021-06-21, 1400/03/31
Registration timing:retrospective
Last update:2021-06-21, 1400/03/31
Update count:0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-05-30, 1400/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on planned behavior Theory on the promotion of sexual & reproductive health of women with endometriosis
Public title
The effect of education on promoting sexual health and fertility in women with endometriosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Women with endometriosis based on medical tests or medical diagnosis and clinical signs 2- No history of participating in training or counseling classes 3- Having Iranian nationality 4- Age between 15 to 45 years 5- Having the ability to read and write 6- Non-addiction (based on patient file information available at the center) 7- Do not consume alcohol 8- No known chronic diseases 9- No chronic psychiatric disorders and known malignant diseases (self-reported) 10. Being married or living with a spouse 11- Ability to use the Internet and cyberspace if the intervention is done virtually
Exclusion criteria:
1-Having genital or reproductive infections at the same time as endometriosis 2- Having underlying diseases 3- single 4- Not being able to use cyberspace and smart phone
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by randomized block design of two treatments with quadruple blocks. The letter A is for the intervention group and the letter B is for the control group. Then we write all the permutation compounds, which are 6 different compounds, on 6 cards as follows:
1. AABB,
2. ABBA,
3. ABAB,
4. BAAB,
5. BABA,
6. BBAA,
Then we will choose a digit from numbers 1 to 6 by drawing. For example, if the number 2 is selected, it means that the first person in the intervention group will be the next two people in the control group and the fourth person in the intervention group.
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 Tehran University of Medical Sciences
Street address
Gods Ave, Keshavaz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
۸۶۵۳۲۴۰۹۷۲
Approval date
2020-12-28, 1399/10/08
Ethics committee reference number
IR.TUMS.FNM.REC.1399.148
Health conditions studied
1
Description of health condition studied
endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
sexual & reproductive health
Timepoint
Before the study, 4 weeks after the intervention, eight weeks after the intervention
Method of measurement
Endometriosis Reproductive Health Specific Questionnaire(ESHQ)
Secondary outcomes
empty
Intervention groups
1
Description
The present intervention is based on the model of the theory of planned behavior, which is a suitable theory for changing behavior. This model is defined based on the four elements of knowledge, attitude, mental norms and perceived behavioral control, and in this study, educational content will be designed based on this element. Intervention group: In addition to routine actions, the intervention group will receive training sessions. These sessions are held online in person as much as possible and in severe cases of illness. 4 training sessions for 120-190 minutes per week will be performed for the participants for four weeks. The content of the sessions includes educational videos, posters, slides, Virtual and video conversations and online tests. Training activities based on this model for women with endometriosis in the structures of the model of the theory of planned behavior will be summarized as follows: first session: Educational content of this session includes: History of endometriosis in Iran and the world, latest global and national statistics Related to endometriosis will be the importance of endometriosis, the definition of endometriosis, the causes of endometriosis, age groups at risk, and ways to prevent endometriosis. At the end of the session, after summarizing the topic, their questions will be answered. Second session: The content of the training program of the second session including: the effect of endometriosis on vital body function, symptoms and clinical course of endometriosis, disease stages, diagnostic methods, referral time To the doctor and midwife before and after the diagnosis, what to do after the diagnosis of endometriosis, treatment of endometriosis, misconceptions about endometriosis and the importance of nutrition in patients. Third session: The content of the educational program of the third session includes: costs related to treatment and follow-up for communities, social, psychological and psychological damage to endometriosis, sexual health and its dimensions, reproductive health, fertility concerns, misconceptions about Pregnancy, the importance of improving sexual health, sexual function and reproductive health in patients, the importance of obtaining accurate information about endometriosis, using and transmitting this information to others to increase their awareness and knowledge to help improve sexual health And their fertility. fourth session: At the beginning of the fourth session, a review of the issues raised in the previous session will be done and the questions and ambiguities of the people will be answered. During this session, misconceptions about not being pregnant, positive and negative attitudes toward endometriosis, mental beliefs, knowledge and attitudes about the disease, motivation to follow influential people and mental norms will be examined in a group discussion. At the end, a summary of what has been taught during the previous sessions will be presented to the people and their questions will be answered.
Category
Behavior
2
Description
Control group: The control group does not receive any intervention and receives routine care by the clinic
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic of Imam Khomeini Hospital in Tehran
Full name of responsible person
Niyosh Zandi
Street address
Tohid Squre, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 8721
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadm
Street address
No. 234, Alvand Ave, Theran
City
Tehran
Province
Tehran
Postal code
۸۷۵۴۳۲۰۸۸۵
Phone
+98 21 8854 2378
Email
behboodi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Trhran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Behboodi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niyosha Zandi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6654 2398
Email
n-zandi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niyosha Zandi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
n-zandi@razi.tums.ac.ir
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