Determining the effect of mindfulness education on reducing rumination and improving sexual function in women with breast cancer.
Design
A randomized clinical trial is being conducted on 52 patients with breast cancer. The subjects are randomly assigned to two groups of 26 test and control groups.
Settings and conduct
Individuals from among patients with breast cancer who are referred to the hematologic department of Bushehr Hospital, a hematologic clinic with a case study and are eligible to participate in the study. The purpose of the research will be provided through interviews with the clients. If you wish, you will receive written consent from the people. Sexual performance questionnaire is then completed by each woman with breast cancer. If these patients have at least one functional disorder in their area and their sexual function score is below9.3 in each area, they are considered to be disrupted and enter the study. The rumination questionnaire is then completed by women with breast cancer
Participants/Inclusion and exclusion criteria
Entry criteria: Women with breast cancer and at least lobectomy.
Failure of the patient to interfere with sexual function (ovarian removal in women, mental problems, Alzheimer's and mental retardation and multiple sclerosis).
Exit criteria: Physical disability due to periods of treatment
Husband travels during the intervention and follow-up
Intervention groups
Interventions and training packages for the training of mind-mindedness based on stress reduction (Kabat Zayn) will be provided by the instructor during 8 sessions. The control group receives a teaching pamphlet on stress-based mind-focused exercises.
Main outcome variables
Sexual function; rumination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090522001930N2
Registration date:2018-08-08, 1397/05/17
Registration timing:registered_while_recruiting
Last update:2018-08-08, 1397/05/17
Update count:0
Registration date
2018-08-08, 1397/05/17
Registrant information
Name
Hakimeh Vahedparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 8498
Email address
h.vahedparast@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness Training on Rumination and Revealing Sexual Function in women with Breast Cancer.
Public title
A Survey on Mindfulness Training in women with Breast Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have breast cancer and at least have lobectomy.
Women of childbearing age .
Minimum reading and writing education so that they can complete the questionnaire form.
Have a wife.
Consciousness and willingness to participate in the research.
Have enough physical ability to attend meetings and collaborate on doing assignments.
Do not use medicines that affect sex .
Radiation therapy should last for at least three months from the last chemotherapy.
From the onset of the disease to the time of research they have not received psychological treatment.
Exclusion criteria:
The intention of the husband to travel during the intervention and follow-up
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
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 Bushehr University of Medical Sciences
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.BPUMS.REC.1396.1396.218
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
c50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention begins, after the intervention, as well as one month after the intervention
Method of measurement
Women's Sexual Function Questionnaire 19 questions
2
Description
Rumination
Timepoint
Before the intervention begins, after the intervention, as well as one month after the intervention
Method of measurement
Nulen Hoeksma and Marlow's Rumination Questionnaire 22 Questions
Secondary outcomes
empty
Intervention groups
1
Description
The intervention of this study is based on the educational package of mind-mindedness based on reducing the stress of Mindfulness of Cubat Zayn. The content of the training has been confirmed by 2 professors in the field of clinical psychology and mindfulness with a valid degree in mind awareness. Training in 8 sessions of two hours during a two-month (weekly one-session) session for an intervention group divided into two groups of 13 will be provided by a trainer at the Yoga Arts and Arts Hall. The homework assignments will be given in a pamphlet and the voice will be given to them, and next week they will be interviewed about the exercises, and questions will be asked about the exercises. If the individuals in the intervention group do not attend the meetings twice, they will be re-classed for them, and if they do not attend more than 2 sessions in the classroom, they will be excluded from the study. If they have a question, we will also respond.
Category
Rehabilitation
2
Description
Control group: Routine care. At the end of the study, the control group will be given an educational counseling session for mindfulness exercises.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Hematology shohadaye khalij Hospital
Full name of responsible person
Rezvan Sohrabi Nejad Masters of Nursing
Street address
shohadaye khalij Hospital, Bushehr, Bushehr Province
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۷۹۳۳۷۵۵
Phone
+98 77 3345 5381
Email
rezvan.sohrabi69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Khamisipour
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
rezvan.sohrabi69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Hakimeh vahed Parast
Position
Assistant Professor of Bushehr Nursing Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
hk_vahdparast@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Hakimeh vahed Parast
Position
Assistant Professor of Bushehr Nursing Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
hk_vahdparast@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Hakimeh vahed Parast
Position
Assistant Professor, Faculty of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
hk_vahdparast@yahoo.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
No more information
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