- Efficacy of mindfulness based stress reduction on depression, anxiety, stress, anger, spirituality well being and hope in women with breast cancer
Design
The sample consists of 30 breast cancer patients who will be selected from among the respondents and then will be randomly assigned to two groups (15 in the experimental group: the group that will be trained in meditation exercise and 15 People for the control group).
Settings and conduct
After studying and signing consent form, participants are randomly replaced in groups. Subsequently, the test group members will undergo a stress-based education training, after a full explanation of their research and satisfaction from them for 8 weeks, weekly in one session and about two hours and a half to three hours. All subjects will complete all research tools in two rounds. Upon completion of the eight sessions of Mindfulness Training, again, both the test (test and control) will be tested by research tools. The site of the project in the hospital's oncology section Civilized will be Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged over 30; diagnosis of cancer in stages 1 and 2; having at least the literacy; satisfaction to participate in research
Exclusion criteria: history of medical diseases; history of psychiatric disorder
Intervention groups
Experimental group will have mindfulness based stress reduction and control group don't have any interventions.
Main outcome variables
-regulating of negative emotions of breast cancer patients
- Improve the hope of these patients
-Improve the spiritual well-being of these patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171203037729N1
Registration date:2018-01-02, 1396/10/12
Registration timing:prospective
Last update:2018-01-02, 1396/10/12
Update count:1
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Rasoul Heshmati
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3475 7626
Email address
psy.heshmati@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mindfulness Based Stress Reduction (MBSR) on negative emotions, hope and spirituality well-being of women with breast cancer
Public title
mindfulness based stress reduction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age up to 30
Cancer diagnosis in stages 1 and 2
willingness and Satisfaction to participate in research
Having at least literacy
Exclusion criteria:
Getting for other medical conditions
Having a psychiatric disorder
Age less than 30 years
Dissatisfaction to participate in research
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
- simple randomization
- through randomization table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University
Street address
Central Building No. 2, Third Floor, Research & Technology Dept. Golghast St, Tabriz University of Medical Sciences.Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
IR.TBZMED.REC.1396.719
Health conditions studied
1
Description of health condition studied
Brest cancer
ICD-10 code
C00-D48
ICD-10 code description
سرطان سینه
Primary outcomes
1
Description
depression
Timepoint
assessing of depression at the beginning of the study and 2 months after intervention
Method of measurement
Depression, Anxiety and Stress scale
2
Description
anxiety
Timepoint
assessing of anxiety at the beginning of the study and 2 months after intervention
Method of measurement
Depression, Anxiety and Stress scale
3
Description
stress
Timepoint
assessing of stress at the beginning of the study and 2 months after intervention
Method of measurement
Depression, Anxiety and Stress scale
4
Description
Anger
Timepoint
assessing of anger at the beginning of the study and 2 months after intervention
Method of measurement
Spielberg's Anger Scale
5
Description
hope
Timepoint
assessing of hope at the beginning of the study and 2 months after intervention
Method of measurement
Schneider's Hope Scale
6
Description
spiritual well-being
Timepoint
assessing of spiritual well-being at the beginning of the study and 2 months after intervention
Method of measurement
Pulotsin and Ellison Spiritual Well-being Scale
Secondary outcomes
1
Description
psychological well-being
Timepoint
assessing of psychologicall well-being at the beginning of the study and 2 months after intervention
Method of measurement
The Ryff Scales of Psychological Well-Being
Intervention groups
1
Description
Intervention group: Mindfulness based stress reduction is an educational method in which members learn emotion control and concentration techniques once a week and three hours.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid madani hospital
Full name of responsible person
Rasoul Heshmati
Street address
Golgasht street. Shahid madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 4280
Email
phsy.heshmati@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Golgasht Street, Madani Hospital, Tabriz City.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3475 7626
Email
psy.heshmati@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
Rasoul Heshmati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
ّFaculty of psychology, Tabriz university, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Fax
Email
psy.heshmati@tabrizu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rasoul Heshmati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tabriz university . faculty of psychology
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Fax
Email
psy.heshmati@tabrizu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rasoul Heshmati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of psychology, Tabriz university, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Fax
Email
psy.heshmati@tabrizu.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
All data is publishable after being unidentifiable
When the data will become available and for how long
6 month after result publition
To whom data/document is available
for all researchers
Under which criteria data/document could be used
Only for the purpose of using data and protocols in other research work
From where data/document is obtainable
Tabriz-University of Tabriz-Department of Psychology-Mr. Rasoul Heshmati-09198260681 Email: psy.heshmai@gmail.com
What processes are involved for a request to access data/document
Requesting from researcher and sending it by post or e-mail