The effect of mindfulness-based stress reduction training through mobile application on resilience of women with breast cancer
Design
This study is a quasi-experimental study (educational intervention) pretest-posttest with a control group.
Settings and conduct
Decreased resilience following breast cancer is one of the psychological problems experienced by patients. One of the most helpful ways to deal with these undesirable emotional responses is mindfulness-based stress reduction training. women with breast cancer referred to selected medical centers in Rasht, Iran, (Razi Hospital, Besat Clinic) if they have Inclusion criteria will be selected in a convenience manner based on gradual referrals. In order to allocating individuals in the two intervention and control groups, one day clients (even days) will be assigned to the experimental group and the next day clients (odd days) will be assigned to the control group.Data collection tools in this study are demographic information questionnaire and Connor-Davidson standard resilience questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Willingness into the study, being literate, and having a smartphone. Previous and current history of diagnosis of psychiatric disorders based on patient / family opinion, consumption or dependence on alcohol, cigarettes and drugs based on patient / family opinion are the criteria for not entering the study.
Intervention groups
Both intervention and control groups (42 people in each group) of women with breast cancer complete research questionnaires before the intervention and then mindfulness-based stress reduction training software is installed on the intervention group mobile phones and they are trained for 8 weeks. The control group does not receive any intervention from the researcher.
Main outcome variables
Resilience score of women with breast cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170203032374N2
Registration date:2021-08-28, 1400/06/06
Registration timing:prospective
Last update:2021-08-28, 1400/06/06
Update count:0
Registration date
2021-08-28, 1400/06/06
Registrant information
Name
Fatemeh Jafarzadeh-Kenarsari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3278 1272
Email address
jafarzadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based stress reduction education through mobile software on resilience of women with breast cancer
Public title
The effect of mindfulness through mobile software in breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
No history of diagnosis of psychiatric disorders based on patient / family comments
Non-consumption or dependence on alcohol, cigarettes and drugs based on patient / family opinion
Be literate
Not attending mindfulness and stress management training classes
Having a smart phone with Android or iOS system
Exclusion criteria:
Reluctance to continue participating in the study
Lack of regular and complete study of the educational program installed on the mobile phone during the study period
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Guilan University of Medical Sciences
Street address
The old building of the Faculty of Health, in front of 17 Shahrivar Hospital, Shahid Siadati St.Namjoo St. Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2021-06-30, 1400/04/09
Ethics committee reference number
IR.GUMS.REC.1400.147
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.011
ICD-10 code description
Malignant neoplasm of nipple and areola, right female breast
Primary outcomes
1
Description
Resilience score in Connor-Davidson Resilience Questionnaire
Timepoint
Measurement of resilience score at the beginning of the study (before the start of the intervention) and immediately after the intervention and 8 weeks after the end of the educational intervention (Mindfulness-based stress reduction with the help of mobile-based software).
Method of measurement
Connor and Davidson Resilience Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The resilience questionnaire consists of 25 items and five areas: perception of individual competence, trust in individual instincts and negative emotional tolerance of questions, positive acceptance of change and safe relationships, control and negative effects. Before the intervention, both groups will complete the research questionnaires and then the educational software will be installed on the mobile phones of the experimental group and the participants in the intervention group will be trained through this software. Mindfulness-based stress reduction educational content in 8 parts will be compiled by a clinical psychologist and designed by an experienced programming expert in the form of special mobile educational software. After the intervention and 8 weeks after the intervention, the resilience questionnaire will be completed again by both groups and information will be collected. The control group did not receive any intervention from the researcher.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital and Besat Clinic
Full name of responsible person
Yalda Dnyaei-Mobarrez
Street address
Shahid Beheshti School of Nursing and Midwifery Rasht, Daneshjoo St.,Shahid Beheshti Highway,Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Fax
Email
nursing@gums.ac.ir
Web page address
https://www.gums.ac.ir/nmr/Default.aspx?tabid=855
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Naghipour
Street address
Vice Chancellor for Research of Guilan University of Medical Sciences, In Front of 17-Shahrivar Hospital, Shahid-Siadati Av., Namjoo St., Rasht, Guilan, Iran