Determining the Effect of Spirituality Based Mindfulness Education on the Hope and Anxiety of Women with Breast Cancer
Design
60 patients were selected based on entry and exclusion criteria. Then, they were randomly assigned to intervention and control groups.Each group included 30 patients with breast cancer.
Settings and conduct
After selecting patients and randomly assigning them to intervention and control groups, 8 training sessions of 60 minutes were performed in Faculty of Nursing and Midwifery Nasibe ( Sari) for the intervention group. The control group did not receive any intervention.
Participants/Inclusion and exclusion criteria
1. Having a desire to participate in the study
2.Female Sex
3. age group 18-70 years
4. Have a mild to moderate anxiety
5.Being at zero, one or two cancer
6. use of psychological drugs
7. participation in similar training sessions
8.intermediate Education and higher education
Intervention groups
The intervention group included 30 patients with breast cancer. The intervention was conducted in 8 sessions of 60 minutes and grouped.The intervention included spirituality-mindedness training, attention to the effect of spirituality on stress and hope, relaxation techniques, familiarity with the technique of respiratory meditation, familiarity with body examination technique, abdominal respiration technique.The control group also included 30 patients with breast cancer who did not receive any intervention.
Main outcome variables
Stress and Hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171203037723N4
Registration date:2019-03-03, 1397/12/12
Registration timing:retrospective
Last update:2019-03-03, 1397/12/12
Update count:0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
Hamideh Azimi Lolaty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7343
Email address
azimihamideh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-04-23, 1397/02/03
Actual recruitment start date
2018-07-01, 1397/04/10
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2018-09-22, 1397/06/31
Scientific title
The effect of Mindfulness-based spirituality training on the hope and anxiety of women with breast cancer
Public title
The Effect of Spirituality Based Mindfulness Training on the Hope and Anxiety of Women with Breast Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a willingness to participate in the study
Female sex
Age group is 18-70 years old
Having a mild to moderate anxiety
Being at zero, one or two cancer
intermediate Education and higher education
Exclusion criteria:
use of psychological drugs
Participate in similar training sessions
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected by the available sampling method from the research community and randomly divided into intervention (30) and control (30 persons) groups.
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 Mazandaran University of Medical Sciences
Street address
Sari Street Teacher, Student Research Deputy
City
sary
Province
Mazandaran
Postal code
48157-33971
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
162.IR.MAZUMS.REC.1397
Health conditions studied
1
Description of health condition studied
Patients with breast cancer
ICD-10 code
Malignant
ICD-10 code description
C50
Primary outcomes
1
Description
Anxiety score
Timepoint
Before the intervention - Immediately after intervention
Method of measurement
Beck Anxiety Inventory
2
Description
Hope
Timepoint
Before the intervention - Immediately after intervention
Method of measurement
Miller's Hope Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with breast cancer participated in educational sessions. Eight sessions of one hour, group and weekly held. The content of the training sessions included spirituality-based mind-awareness training, the effect of spirituality on stress and hope, body examination, breathing meditation, abdominal respiration, and relaxation techniques. The lecture and questioning method was used.
Category
N/A
2
Description
Control group: Thirty women with breast cancer entered the control group.The control group did not attend the training sessions. This group only completed questionnaires.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban Specialist Clinic
Full name of responsible person
Hamideh Azimi Lolaty
Street address
Sari - Khazar Boulevard
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Fax
Email
azimihamideh@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi Lolaty
Street address
Mazandaran University of Medical Sciences, Three Way Joybar, Beginning of the Highway of Vali Asr, Imam Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 7333 0547
Email
midnasibeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi Lolaty
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amir Mazandaran Blvd., Vesal Shirazi Ave. Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
azimihamideh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
hamideh Azimi Lolaty
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amir Mazandaran Blvd., Vesal Shirazi Ave. Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
azimihamideh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi Lolaty
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amir Mazandaran Blvd, Vesal Shirazi Ave. Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
azimihamideh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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