Determination of the effect of counseling based on cognitive-behavioral approach on self-esteem of hysterectomized women in reproductive ages
Design
This research is a clinical trial with pretest-post test design with control group and with parallel groups without blindness. The sample size is 40 people and will be divided into two groups of control and test according to the random numbers table .
Settings and conduct
This research will be carried out on women of reproductive age in the Imam Hospital of Ahvaz. To select samples from the available sampling method, they will be invited by telephone call. After obtaining the consent and justification of the participants about the goals of the study and its implementation, as well as ensuring the confidentiality of the results, the demographic questionnaire and Rosenberg self-esteem are completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria include women of reproductive age of 15-45 years, at least 2 months have passed since hysterectomy, have reading and writing skills, physical and mental health, gain less than 15 points in the Rosenberg Self-Esteem Questionnaire.
Exclusion criteria include taking psychiatric drugs, history of preoperative psychiatric disorders, severe depression, history of mastectomy and history of uterine cancer.
Intervention groups
The test group will receive 12 sessions of 60 minutes, group cognitive-behavioral counseling, twice a week.
The control group does not receive intervention. After the end of the study, they will receive a educational CD of meetings for observance of ethical standards.
Main outcome variables
Mean score of self-esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180222038828N1
Registration date:2018-05-11, 1397/02/21
Registration timing:prospective
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
Golnoosh Mohamadnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3372 4455
Email address
mohamadnejad.g@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-20, 1397/02/30
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of counseling based on cognitive-behavioral approach on self-esteem of hysterectomized women in reproductive ages
Public title
The effect of cognitive-behavioral approach on women's self-esteem
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age of 15-45 years
At least 2 months have passed since hysterectomy
Have reading and writing skills
Have physical and mental health
Having a score of less than 15 in the Rosenberg Self-Esteem Questionnaire
Exclusion criteria:
Taking psychiatric drugs
History of psychiatric disorders Before surgery
Major depression
History of mastectomy
History of uterine cancer
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to one of the two test and control groups using simple randomization sequences. and hiding random allocation through the use of sealed non-transparent envelopes.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Assistant Professor of Research and Information Technology, Ahvaz Jundishapur University of Medical Sciences, Ground floor
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.AJUMS.REC.1396.908
Health conditions studied
1
Description of health condition studied
Hysterectomy
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ(s)
Primary outcomes
1
Description
Self-esteem
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Rosenberg self-esteem questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twelve sessions of cognitive behavioral intervention . The duration of each session is 60 minutes and twice a week.
Category
Behavior
2
Description
No intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Hospital
Full name of responsible person
Golnoosh Mohamadnejad
Street address
Imam Hospital, Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2085
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research, Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz, Deputy of Research, Ahwaz Jundishapur University of Medical Sciences, Ground floor
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
Mohamadnejad.g@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamadnejad Golnoosh
Position
Master's degree in midwifery counseling
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd, Golestan Dormitory
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 84 3372 4455
Email
Mohamadnejad.g@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Tadayon Mitra
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3311
Email
tadayon_m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamadnejad Golnoosh
Position
Master's degree in midwifery counseling
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd, Golestan Dormitory
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 84 3372 4455
Email
Mohamadnejad.g@ajums.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
Undecided - It is not yet known if there will be a plan to make this available
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