Investigating the effect of brief Mindfulness-based Cognitive Therapy (b-MBCT) on the married women’s body image and quality of sexual life after hysterectomy in Kerman, 2020
investigating the effect of b-MBSR on body image and quality of life after hysterectomy in married women in Kerman
Design
The research is an applied research with pre-test, post-test and intervention and control group which will be done after the approval of the code of ethics by Kerman University of Medical Sciences. Then, to obtain the statistical population of all hospitals in Kerman where hysterectomy will be performed. They will be enrolled in the study and will be randomly selected from 4 hospitals. Then, women who live in Kerman province who have undergone hysterectomy in these 4 hospitals will be evaluated for at least 2 months and up to 2 years after their hysterectomy.
Settings and conduct
PLACE OF SESSIONS: hysterectomy hospitals. post-test will be given to the two groups again after the end of the training sessions and again a month later.
Participants/Inclusion and exclusion criteria
Specimens were at least two months after hysterectomy
• They are under 65 years of age.
• Married and sexually active
• The ability to understand your body image
• Not be counseled about other psychological problems during the study or after the hysterectomy and prior to this consultation.
• Non-addiction to drugs, stimulants and alcohol based on an individual report
• Be literate
• Lack of chronic illness such as: psychotic disorders, physical and mental disabilities
• Reside in Kerman province.
• Lack of psychiatric medication
• Maximum 2 years since hysterectomy
Exclusion criteria:
There is a reluctance to participate in the study at any stage of the study
Have more than two sessions of counseling sessions
Intervention groups
Intervention group will receive short mindfulness-based cognitive counseling program consisting of 4 120-minute sessions that will be held once a week.
Main outcome variables
mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034452N10
Registration date:2020-03-07, 1398/12/17
Registration timing:prospective
Last update:2020-03-07, 1398/12/17
Update count:0
Registration date
2020-03-07, 1398/12/17
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-24, 1399/01/05
Expected recruitment end date
2021-04-25, 1400/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of brief Mindfulness-based Cognitive Therapy (b-MBCT) on the married women’s body image and quality of sexual life after hysterectomy in Kerman, 2020
Public title
the effect of brief Mindfulness-based Cognitive Therapy (b-MBCT) on the married women’s body image and quality of sexual life after hysterectomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Sample subjects at least two months after their hysterectomy
Married
Ability to self-perceive self
Not attending in counseling sessions for her psychological problems during this study
No self-report drug, stimulant and alcohol dependence
Primary literacy
Not suffering from chronic illnesses
No medication Psychiatry
surgery are younger than 65.
must be at least 2 years since the hysterectomy
sexually active with her husband
Exclusion criteria:
Do not attend two or more counseling sessions
Not willing to countinue participating in the study while doing research.
Age
To 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
simple individual randomization through randomization table of random numbers. allocation concealment will be done
Blinding (investigator's opinion)
Single blinded
Blinding description
Intervention group samples do not meet with control group samples at any point in the study, so the probability of individuals in the intervention group being in control is very low and information exchange is not likely to occur. for data analyzer we send the data to him/her without mentioning intervention and control group and instead we will label them with A and B. for data and safety monitoring board we will not aware them about the group of intervention as it is possible only if they request for checking the accuracy of the intervention. for outcome assessor, they only asked the posttest questions by telephone without being aware that which woman is in which group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kerman University of Medical Sciences
Street address
kerman-first of Haft Bagh Alavi-Pardis of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
76169135555
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KMU.REC.1398.597
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
Body image in hysterectomy women
Timepoint
Befor intervation after the intervation
Method of measurement
Multidimensional Body-Self Relation Questionnaire
2
Description
Quality of sex life in hysterectomy women
Timepoint
Before intervention
Method of measurement
Sexual Quality of Life Questionnaire
3
Description
Body image in hysterectomy women
Timepoint
after intervention
Method of measurement
Multidimensional Body-Self Relation Questionnaire
4
Description
Quality of sex life in hysterectomy women
Timepoint
after intervention
Method of measurement
Sexual Quality of Life Questionnaire
5
Description
Quality of sex life in hysterectomy women
Timepoint
one month after intervention
Method of measurement
Sexual Quality of Life Questionnaire
6
Description
body image in women undergone hysterectomy
Timepoint
one month after intervention
Method of measurement
Multidimensional Body-Self Relation Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention as a Mind-Based Cognitive Counseling Short-Awareness on Body Image After Hysterectomy. intervention is brief-mindfulness based cognitive therapy for women between 2 months to 2 years after their hysterectomy (4 sessions 120 minutes).The sessions will hold in the hospital they undergone hysterectomy or any other places that they are eager to be hold. content of counseling sessions: first session: greeting and definition of sessions rules, definition of b-mbct, body image, quality of sexual life and related factors among women undergone hysterectomy, stress and mindfulness. body scan technique, home work session two: review of previous session, influence of our interpretation of our emotions, self-awareness and body-awareness, focus on breathing, hearing and vision, homework session 3: definition of cognitive errors, negative and positive thoughts, mindful walking, homework session 4: influence of love. though acceptance automatic pilot, mountain meditation, homework
Category
Treatment - Other
2
Description
Control group: َAfter the intervention they can attend the sessions
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals where hysterectomies were performed or as requested by research units
Full name of responsible person
Elahe Bahador
Street address
Haft-bagh Alavi
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 31 3226 3815
Email
kmu-research@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Street address
Keman-first element of the Haft Bagh Allavi-Pardis of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kmusrc@googlegroups.com
Web page address
http://vresearch.kmu.ac.ir/fa
Grant name
deputy of research Kerman University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
deputy of research Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Elahe Bahador
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
First of the Haft Bagh Alavi-Pardis of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 295 6143
Email
elahebahador6466@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefe Ahmadi
Position
Proffesor assistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman-first element of the Haft Bagh Allavi-Pardis of kerman University
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac .ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefe Ahmadi
Position
Proffessor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman-first element of the Haft Bagh Allavi-Pardis of kerman University
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on the main outcomes of the research after the completion of research work can be published.
When the data will become available and for how long
Data on the main outcomes of the research after the completion of research work can be published.
To whom data/document is available
Starting access to the data above is immediately after publishing the results.
Under which criteria data/document could be used
Researchers in academia and scientific institute are able to access research data.
From where data/document is obtainable
atefeahmadi59@gmail.com monashirzad1992@yahoo.com
What processes are involved for a request to access data/document
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