the effectiveness of cognitive-behavioral therapy counseling on perceived stress and fear of negative evaluation in hysterectomized women of reproductive age.
The effect of cognitive behavioral counseling on perceived stress and fear of negative evaluation in hysterectomy women at childbearing age
Design
It is a clinical trial with a pre-test-post-test design with a parallel control group and without blinding. The sample size includes 72 people and they will be divided into two control and test groups based on the table of random numbers.
Settings and conduct
This research will be conducted on hysterectomized women of reproductive age in Imam Ahvaz Hospital. In order to select the samples from the available sampling method, they are invited to cooperate through a phone call. After obtaining the consent and justification of the participants regarding the objectives of the study and the method of implementation, as well as ensuring the confidentiality of the results, the demographic questionnaire, the perceived stress questionnaire, and the fear of negative evaluation questionnaire are completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Women 18 to 45 years old; At least 2 months and at most 12 months have; passed since hysterectomy; Being literate in reading and writing; Having a minimum score higher than 21.8 in the fear of negative evaluation questionnaire and 24 in the perceived stress questionnaire; Married women with husbands; Hysterectomy women; Having at least two children. Exclusion criteria; Diagnosis of malignancy before or after hysterectomy surgery; Taking psychiatric drugs; Women with primary infertility; History of mastectomy
Intervention groups
The test group will receive 10 group CBT sessions for 90 minutes, 2 times a week. The control group does not receive any intervention. After the end of the research, they will receive an educational CD of the sessions in order to comply with the ethical standards
Main outcome variables
Average score of perceived stress; fear of negative evaluation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240523061874N1
Registration date:2024-06-17, 1403/03/28
Registration timing:prospective
Last update:2024-06-17, 1403/03/28
Update count:0
Registration date
2024-06-17, 1403/03/28
Registrant information
Name
seddigheh rashidimoghaddan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 378 8273
Email address
saeederashidi1989@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effectiveness of cognitive-behavioral therapy counseling on perceived stress and fear of negative evaluation in hysterectomized women of reproductive age.
Public title
The effect of cognitive-behavioral counseling on perceived stress and fear of negative evaluation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18 to 45 years old
At least 2 months and at most 12 months have passed since hysterectomy
Being literate in reading and writing
Having a minimum score higher than 21.8 in the fear of negative evaluation questionnaire and 24 in the perceived stress questionnaire
Married women with husbands
Hysterectomy women
Having at least two children
Exclusion criteria:
Diagnosis of malignancy before or after hysterectomy
Use of psychiatric drugs
History of mental illnesses before surgery
Previous history of using cognitive behavioral methodology
Women with primary infertility
History of mastectomy
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention to people is randomly and by the method of randomized permutation blocks with random block sizes of 4, 6 and 8 (using the table related to random permutations). The randomization list will be prepared by the statistician. The intervention used in this research is allocated according to the randomized list by a person outside the study who is not aware of the research objectives and according to the corresponding codes in the sealed 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 Jundi Shapur Ahvaz University of Medical Sciences
Street address
Vice-Chancellor of Research and Information Technology, Jundishapur University of Medical Sciences and Health Services, Ahvaz, ground floor
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.AJUMS.REC.1403.102
Health conditions studied
1
Description of health condition studied
Hysterectomy
ICD-10 code
Acquired a
ICD-10 code description
Z90.7
Primary outcomes
1
Description
Perceived stress and fear of negative evaluation
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire of perceived stress and fear of negative self-evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receives ten sessions of cognitive behavioral intervention. The duration of each session is 90 minutes and twice a week
Category
Behavior
2
Description
Control group: No intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ahvaz Hospital
Full name of responsible person
Seddighe Rashidi Moghaddam
Street address
Imam Hospital, Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2085
Fax
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vice-Chancellor of Research at Jundishapur University of Medical Sciences and Health Services, Ahvaz
Street address
ground floor, Jundishapur University of Medical Sciences and Health Services Research Vice-Chancellor, Ahvaz,iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
saeederashidi1989@gmail.com
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
Seddighe Rashidi Moghaddam
Position
Master's student in counseling in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard, Golestan Hostel
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3321 4581
Email
saeederashidi1989@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tedin Najafabadi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur University, Faculty of Nursing and Midwifery
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
Seddighe Rashidi Moghaddam
Position
Master's student in counseling in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard, Golestan Hostel
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3321 4581
Email
saeederashidi1989@gmail.com
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