Determining the effect of education based on family-centered empowerment model on social support and quality of life of women with endometriosis
Design
The clinical trial has a control group with parallel groups, randomized on 64 women with endometriosis. Sampling by the available method, randomization using the site.
Settings and conduct
This study is a randomized clinical trial with pre-test, post-test and control group. Sampling will be done using the available method from women with endometriosis referring to the women's clinic of Imam Reza (AS) Mashhad Hospital who meet the entry criteria. The intervention will be done only for the test group and according to the steps of the family-centered empowerment model
Participants/Inclusion and exclusion criteria
Age between 18-50 years, having at least basic literacy, patients who have endometriosis diagnosed by a gynecologist with the help of sonography and are candidates for medical treatment, the onset of endometriosis symptoms at least in the last 6 months, not taking antidepressants and sedatives in the last 3 months, and satisfaction The patient and his wife, no history of malignant diseases, no unpleasant events such as the death of relatives in the last three months, living with his wife.
Intervention groups
The intervention group is all women with confirmed endometriosis who will receive 5 training sessions and 1 final assessment session of 45-60 minutes based on the family-centered empowerment model during two weeks (one day in between) at the women's clinic by the researcher.
Main outcome variables
The main outcome of quality of life score, social support score, and family-centered empowerment model structures score in women with endometriosis before and 1.5 months after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220720055505N1
Registration date:2022-07-31, 1401/05/09
Registration timing:prospective
Last update:2022-07-31, 1401/05/09
Update count:0
Registration date
2022-07-31, 1401/05/09
Registrant information
Name
Maryam Armaghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3765 4407
Email address
armaghanm992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on family centered empowerment model on social support and quality of life of women with endometriosis
Public title
The effect of education based on family centered empowerment model on social support and quality of life of women with endometriosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-50 years,
having at least basic literacy
patients who have endometriosis diagnosed by a gynecologist with the help of sonography and are candidates for medical treatment
the onset of endometriosis symptoms at least in the last 6 months
not taking antidepressants and sedatives in the last 3 months
satisfaction the patient and her husband
not history of malignant diseases
no unpleasant events such as the death of relatives in the last three months
living with his husband
Exclusion criteria:
The patient's unwillingness to participate in the research, the person's pregnancy, the malignant diseases, patients who are candidates for surgical treatment, patients with other chronic diseases, patients who do not have the conditions to participate in training sessions.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly assigned to two control and intervention groups using the random permutation block method with blocks of size 4. For this purpose, 16 blocks that have 4, were randomly selected from the website https://www.sealedenvelope.com.
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 Mashhad University of Medical Sciences
Street address
No. 32, Yas 8, Ferdowsi 5, Ferdowsi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9197614661
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.032
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Quality of life score
Timepoint
At the beginning of the study and 1.5 months after the end of the intervention
Method of measurement
Specific endometriosis quality of life questionnaire(EHP30)
2
Description
Social support score
Timepoint
At the beginning of the study and 1.5 months after the end of the intervention
Method of measurement
Sherbon Stewart Social Support Questionnaire
3
Description
Questionnaire score of family-centered empowerment model structures
Timepoint
At the beginning of the study and 1.5 months after the end of the intervention
Method of measurement
Questionnaire made by the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People with endometriosis in the intervention group will receive 5 training sessions based on the family-centered empowerment model during two weeks (every other day) at the women's clinic by the researcher. Each session will be held for 45 to 60 minutes. The training sessions will be held in groups of 6-7 people. The intervention will be done only for the test group and it will last for eight weeks (2 weeks of training sessions and 6 weeks for practice sessions and then evaluation).The intervention is designed based on the structures of the family-centered empowerment model and includes: the first step (perceived threat): this step is conducted during two 60-minute sessions by the researcher and with the method of speech and group discussion for the patient, with the aim of increasing knowledge and understanding and in The result of understanding the threat by becoming aware of the nature and symptoms of endometriosis and important issues regarding nutrition, exercise and other effective factors in controlling the disease will be implemented in Imam Reza Hospital.The second step (self-efficacy): this stage will be carried out by means of group discussion and during 2 sessions of 60 minutes, in which people will use each other's experiences for better control of the disease, they will get to know the problems and the process of solving the problem, and their proposed solutions. will present and then the best solution will be chosen. Also, the ability to recognize drugs, dosage of drugs and their side effects will be discussed in group discussion and expression of experiences. The third step of self-belief and self-esteem is through educational participation. In this step, the researcher provides educational pamphlets to the patients and asks them to teach their wives what they have learned.And then, during a virtual session, the researcher completes the learned material for the spouses of the patients and solves the ambiguities. The researcher will follow up the implementation of the programs through phone calls. The fourth step (evaluation): includes the evaluation of the process, which is obtained during the intervention process and in each session by asking oral questions from learning the contents of the previous sessions, and then the final evaluation will be done 1.5 months after the intervention by completing the questionnaires again. became. During this 1.5 month, the researcher will follow the implementation of the program through phone calls
Category
Lifestyle
2
Description
Control group: Control group: The control group also receives only the usual measures of the endometriosis clinic. In terms of respecting the ethical issues of the research, the patients and their spouses in the control group will be given educational pamphlets.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr. Azam PourHOseini
Street address
Imam Reza (AS) Educational Research and Treatment Center, Imam Reza (AS) Hospital Square, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
pourhoseinia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohamad Ali Kiani
Street address
University St, Khorasan Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street, University Street, Doctor's Crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 3-38591511
Email
MirzakhaniK@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street,University Street, Doctor's Crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 3-38591511
Email
MirzakhaniK@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Armaghan
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.32, Yas8, Ferdowsi 5, Blvd Ferdowsi
City
Mashhad
Province
Razavi Khorasan
Postal code
9197614661
Phone
009 51 37654407
Email
ArmaghanM992@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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