Comparison of the Effectiveness of Spiritual Therapy and Mindfulness Education on Quality of Life, Life expectancy and resilience in breast cancerous patients
At Dr. Ghaliani's consulting office in Park Wei, after explaining the purpose of the intervention and obtaining informed consent, patients answered the questionnaires. Then, by block random method, they were divided into two groups of 15 samples (No. 1 and 2). Spiritual therapy was performed for group 1 and mindfulness training for group 2. The intervention was performed in 8 individual and face-to-face sessions of 30-45 minutes. After the intervention in the first stage, the questionnaires were completed by both groups. A one-week break was given. Questionnaires were completed again by both groups. At this stage, mindfulness training was performed for group 1 and spiritual therapy was performed for group 2. At the end of the second eight sessions, the questionnaires were completed again by both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with breast cancer. Exclusion criteria: History of mental illness in the past or present;
history of taking psychiatric drugs.
Intervention groups
Spiritual therapy based on the sound heart model and mindfulness education
Main outcome variables
Quality of life, life expectancy and resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190715044212N1
Registration date:2020-11-12, 1399/08/22
Registration timing:retrospective
Last update:2020-11-12, 1399/08/22
Update count:0
Registration date
2020-11-12, 1399/08/22
Registrant information
Name
Bahare ghalyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2276 4267
Email address
dr_bahare_ghalyani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
2019-11-06, 1398/08/15
Actual recruitment end date
2019-12-06, 1398/09/15
Trial completion date
2020-02-29, 1398/12/10
Scientific title
Comparison of the Effectiveness of Spiritual Therapy and Mindfulness Education on Quality of Life, Life expectancy and resilience in breast cancerous patients
Public title
Comparison of the Effectiveness of Spiritual Therapy and Mindfulness Education on Quality of Life, Life expectancy and resilience in breast cancerous patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Breast Cancer Disease
Diploma and higher education
Degree of disease between level 1 to 3
Being able to communicate and understand the lessons
Familiarity with Persian language
Exclusion criteria:
History of mental illness in the past or present
history of taking psychiatric drugs
Taking psychotropic drugs or a history of drug addiction
Having another illness, or complications that may result in hospitalization in ICU
Unwilling to continue research during the study
Simultaneous participation in other research
The occurrence of a major life crisis in addition to the illness crisis during the study
Age
From 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The name of the people with consent form were written on the similar papers and folded, mixed and put into a container, then we asked one person outside the study group to pull each paper out of the container in a row with closed eyes and assign them in two groups A or B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
model-based
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Research of Islamic Azad University Science and Research Branch
Street address
University of Science and Research , End of Sattari Highway
City
Tehran
Province
Tehran
Postal code
32224574145
Approval date
2019-10-16, 1398/07/24
Ethics committee reference number
IR.IAU.SRB.REC.1398.149
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of Life: The World Health Organization (2000) defines the concept of quality of life in terms of people's understanding of their life situation in terms of their culture, the value system they live in, their goals, expectations, standards and priorities (Karimloo et al., 2010).
Timepoint
Pre-test and Post-test
Method of measurement
Quality of Life Questionnaire
2
Description
Life expectancy: Life expectancy is a mental set that is based on a mutual sense of will and planning to achieve a goal (Schneider et al., 2006).
Timepoint
Pre-test and Post-test
Method of measurement
Hope Questionnaire
3
Description
Resilience: In the Merriam-Webster culture, resilience is called the ability to recover after difficult conditions or to adapt to those conditions. In other words, resiliency is one of the behavioral traits of individuals who are exposed to certain risk factors and can overcome the risks and avoid negative consequences such as delinquency and behavioral problems (Massen, 1999).
Timepoint
Pre-test and Post-test
Method of measurement
Conner and Davidson's Resiliency Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group: The interventions were made in both groups. A quasi-experimental crossover design method was used. To this end, a pre-test design, including the quality of life, life expectancy, and resilience questionnaires, was initially implemented for all the subjects. The subjects were then matched based on age, education level, and the degree of disease who were randomly assigned to two groups of A and B. The spiritual therapy interventions’ plan was implemented for group A, while group B received the mindfulness training. A post-test of the three mentioned scales (quality of life, life expectancy, and resilience) was implemented for both groups three days after the end of all interventions for both test groups.
Category
Behavior
2
Description
The second Intervention group: The interventions were changed for the groups after one week; i.e., group B received the spiritual therapy training and mindfulness training was implemented for group A. The post-test design was conducted for both groups three days after the end of the training course. Finally, the results of the mean values of each group, and each individual were evaluated and compared with themselves. The findings were also analyzed using SPSS software, Ver. 23.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Minoo Asadzandi
Street address
Hospital Baqiyatallah,Mulla Sadra Street ,Vanak Square in
City
Tehran
Province
Tehran
Postal code
524412562
Phone
+98 21 81261
Fax
+98 21 8805 1511
Email
zandi498@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abdolmajid Bahraynian
Street address
Science and Research Branch, Islamic Azad University
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Fax
Email
zandi498@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
فردی
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abdul Majid Bahraini
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hemmat highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14256325
Phone
0098218825685
Fax
Email
majid-bahrainian36@yahoo.com
Web page address
https://www.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Minoo Assadzandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Baqiyatallah Hospital,Mallak Sadra Street Vanak Square
City
Tehran
Province
Tehran
Postal code
585896655
Phone
+98 21 8805 0435
Email
zandi498@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
psychologist
Full name of responsible person
Bahare Ghslyani
Position
psychologist
Latest degree
Master
Other areas of specialty/work
psychologist
Street address
University of Science and Research,Sattari End
City
Tehran
Province
Tehran
Postal code
14585896
Phone
+98 21 4486 5223
Fax
Email
Baharehghalyaee@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
privacy policy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
article publication
When the data will become available and for how long
2020
To whom data/document is available
open access
Under which criteria data/document could be used
scientific article
From where data/document is obtainable
journal site
What processes are involved for a request to access data/document