To determine the Effect of self-care counseling on depression and anxiety in women with Endometriosis.
Design
Randomized controlled Clinical Trial
Settings and conduct
The study will be conducted in Alzahra Medical Educational center of Tabriz city on 76 of 15-45 years old women who have Endometriosis diagnosed with laparoscopy and treated in the last 1-3 years. Women who meet the study criteria will be selected using convenience sampling method and if they would like to participating in the study, informed consent will be obtained. Then, the social and demographic characteristics questionnaire, Beck Depression questionnaire,The Splinberger State-Trait Anxiety questionnaire, and the quality of life scale will be completed by the researcher through interview. The participants will be divided into intervention and control groups by a person who is not involved in the sampling using randomized block design according to their history of infertility with a ratio of 1:1 and a block size of 4 and 6.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Detected Endometriosis with laparoscopy in the last 1-3 years
Being in reproductive age 15-45 year.
Exclusion Criteria:
Presence of any conditions that increase the risk of anxiety and depression.
Having high depression and very severe anxiety score.
Intervention groups
For the intervention group self-care group counselling will be conducted at seven sessions of 60-90 min with one week interval. The controls will receive only the routine care.
Main outcome variables
The main outcome is depression and anxiety, which will be measured before the intervention, and 4 weeks after intervention, using the Beck depression Inventory and the Splineberger State-Trait Anxiety Inventory.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008459N13
Registration date:2019-02-10, 1397/11/21
Registration timing:prospective
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care counseling on depression and anxiety in women with Endometriosis: a randomized controlled trial.
Public title
The effect of counseling on depression and anxiety in women with Endometriosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Residence in Tabriz city
Having at least guidance literacy
Detected Endometriosis with laparoscopy in the last 1-3 years
Being in reproductive age 15-45 year
Having a home and mobile phone number
Exclusion criteria:
Presence of any conditions that increase the risk of anxiety and depression such as Irritable Bowel Syndrome
Use of anti-anxiety and antidepressant drugs over the past 3 months
Self-reported malignant diseases
Having high depression and very severe anxiety score
Recent disastrous events such as death of relatives or divorce that disrupts the mental health of individual
Speech and hearing impairments that prevent communication with researcher
The self-reported history or having psychological problems or history of hospitalization in mental health hospitals
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:
38
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are divided into intervention and control groups using randomized block design according to their history of infertility with ratio 1:1 and a block size of 4 and 6 by a person not involved in the sampling. In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined.
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
1397.788
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Anxiety
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Spilnberger State-Trait Anxiety Inventory
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
The 36 items Quality of Life questionnaire.
Intervention groups
1
Description
For the intervention group (n=38) self-care group counselling will be conducted at seven sessions of 60-90 min, with one week interval by researcher.
Category
Other
2
Description
The control group (n=38) will receive the routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Educational Center
Full name of responsible person
Nooshin Farshi
Street address
Baghshomal crossroad, South Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
shirinhasanpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nooshin Farshi
Position
Ms.c student of counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of NURSING and Midwifery, South Shariaty Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
Nooshin96.farshi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery Faculty.South Shariaty Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
shirinhasanpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nooshin Farshi
Position
Ms.c student of counselling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
Nooshin96.farshi@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