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The effect of cognitive-behavioral group counseling on reproductive health and sexual satisfaction in women with endometriosis

Protocol summary

Study aim
Determining the effect of cognitive-behavioral group counseling on reproductive health and sexual satisfaction of women with endometriosis
Design
A controlled clinical trial with parallel, randomized groups on 96 patients with endometriosis used a random number table using www.randomization.com for randomization.
Settings and conduct
Eligible people in the endometriosis clinic of Imam Reza (AS) Hospital will enter the research according to the inclusion criteria. Then the questionnaires will be completed by two groups. Cognitive-behavioral counseling content in the intervention group in 7 sessions and each session for 90-60 minutes with 6 to 8 people, the first and seventh sessions and a month later, in person and the rest of the sessions will be held virtually. The control group will receive routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women of childbearing age (15-49 years), married, no chronic psychiatric disorders, hemorrhage, having sex, diagnosis of endometriosis based on clinical imaging by a doctor, no accidents during the last 6 months, also Tobacco etiquette, no individual suffering from diseases affecting sexual function, no history of pelvic surgery.
Intervention groups
Intervention group Session 1 Discussion about attitude towards reproductive and sexual health, Session 2 Discussion about mental health problems, Session 3 Reconstruction of negative attitude towards infertility, Session 4 Discussion about physical and sexual problems, Session 5 Cognitive reconstruction and change of negative attitude towards sexual issues, Session 6 Discussion The control group receives the routine care of the center.
Main outcome variables
Endometriosis Reproductive Health (ERHQ) , Sexual Satisfaction Score (SSSW)

General information

Reason for update
Acronym
endometriosis
IRCT registration information
IRCT registration number: IRCT20210919052516N1
Registration date: 2021-11-15, 1400/08/24
Registration timing: registered_while_recruiting

Last update: 2021-11-15, 1400/08/24
Update count: 0
Registration date
2021-11-15, 1400/08/24
Registrant information
Name
maryam nikseresht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 8939
Email address
maryamnik132@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral group counseling on reproductive health and sexual satisfaction in women with endometriosis
Public title
The effect of cognitive-behavioral group counseling on reproductive health and sexual satisfaction in women with endometriosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent to participate in the research Women of childbearing age (15-49 years) Being Iranian and living in Mashhad Have a minimum literacy Getting married and cohabiting Absence of chronic psychiatric disorders and problems in wife and her husband (self-declaration) lack of known chronic diseases in wife and husband Having sex Diagnosis of endometriosis based on history, physical examination and clinical imaging by a physician No accidents during the last 6 months Failure to attend training or cognitive-behavioral counseling classes in the previous 6 months no addiction and alcohol in wife and husband No depression, stress or severe anxiety in a woman and her husband according to the DASS-21 scale Ability to use the Internet and cyberspace if the intervention is done virtually Failure of the person and his wife to get diseases that affect sexual function absence of menopause No history of pelvic surgery Be the only wife of her husband
Exclusion criteria:
Not participating in counseling sessions for more than two sessions and not wanting to continue the intervention Incomplete completion of the questionnaire (answering less than 10% of the questionnaire) Incidence of accidents during the study Receive another training-counseling program during the intervention period.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the permutation block method is used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequence of individuals is done using random allocation software and block size two. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks, AB and BA. One of the blocks is selected at random. If the first block, AB, is selected, the first person is assigned to group A and the second person to group B. And this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers.
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
Ibn sina St, mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.064

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80.9
ICD-10 code description
Endometriosis, unspecified

Primary outcomes

1

Description
Reproductive health
Timepoint
Before and immediately one month after the intervention
Method of measurement
Endometriosis Reproductive Health Questionnaire (ERHQ)

2

Description
Sexual satisfaction
Timepoint
Before and immediately one month after the intervention
Method of measurement
Women's Sexual Satisfaction Scale Questionnaire sssw

Secondary outcomes

1

Description
social support
Timepoint
Before and immediately one month after the intervention
Method of measurement
Standard social support questionnaire

2

Description
Stress - Anxiety - Depression
Timepoint
Before and immediately one month after the intervention
Method of measurement
Stress-Anxiety-Depression Inventory DASS-21

3

Description
Intensity of pain
Timepoint
Before and immediately one month after the intervention
Method of measurement
Severity of pain mediated by VAS criteria

Intervention groups

1

Description
Intervention group: The clinical trial study has a pre-test, post-test and control group with the research community of women with endometriosis. To participate in the research, first the control group and then the intervention group are invited. The required information will be collected using available qualified sampling. In both intervention and control groups, after providing the necessary explanations about the objectives of the research, observing the independence of individuals to participate in the research and the confidentiality of information, participants are asked to complete the informed consent form and then take a sample from them. Be. Patients aged 15-49 years in the intervention group participate in 7 group counseling sessions and each session for 90-60 minutes with 6 to 8 people, the first and seventh sessions and a month later, in person and the rest of the sessions will be held virtually. . Women in the same group will be in the same group in the first counseling session and in the next sessions
Category
Behavior

2

Description
Control group: They receive routine care at a medical center. In addition, they complete the questionnaires before, immediately and one month later.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Endometriosis Clinic of Imam Reza Hospital
Full name of responsible person
Leila Hafizi
Street address
Ibn Sina St., Imam Reza Hospital Square, Imam Reza Research and Treatment Center
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
HafiziL@mums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Erfanian
Street address
Ibn sina St, School of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
ErfanianF@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
Fatemeh Erfanian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ibn sina St, Nursing and Midwifery University
City
mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
ErfanianF@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Nikseresht
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ibn sina St, mashhad university of medical sciences
City
mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
Niksereshtcm982@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Nikseresht
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ibn sina St, School of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
Niksereshtcm982@mums.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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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