The effect of counseling based on mindfulness on quality of life and psychological well-being in women with cervical cancer
Design
Clinical trial with control group, with parallel groups, triple blind, randomized
Settings and conduct
This study will be conducted at the Imam Khomeini and Golestan hospitals of Ahwaz. The researcher will be referred to the research environment with the aim of collecting data and will be included in the study if the patients are willing and have eligibility criteria . The samples were selected by available sampling method. After the initial interview and completion of the questionnaires, the eligible group will be included in the study and will be divided into two groups of intervention and control with random allocation. The intervention group will be subjected to eight sessions of Mindfulness training. The quality of life questionnaire and psychological well-being questionnaires were completed before intervention, immediately after intervention and one month after the intervention, Will be completed in the research environment. In this study, the researcher, samples and statistical analyst are blind.
Participants/Inclusion and exclusion criteria
eligibility criteria :
1. Women with stage IV cervical cancer
2. The quality of life score is less than 50%
3. Score of psychological well-being less than 50
4. Married
5. Having reading and writing skills
6. Accommodation in Ahvaz city
7. Ability to speak Persian in order to answer the questionnaire questions
Exit criteria:
1. Drug Addiction
2. History of the technique of mind-consciousness
3. Getting other acute physical abnormalities
4. Being afflicted with known psychiatric disorders
5. Existence of stressful events during the past six months
Intervention groups
A group that learns mindfulness.
Main outcome variables
Quality of life; psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041505N1
Registration date:2018-11-12, 1397/08/21
Registration timing:registered_while_recruiting
Last update:2018-11-12, 1397/08/21
Update count:0
Registration date
2018-11-12, 1397/08/21
Registrant information
Name
shima Bahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5372 7300
Email address
shimabahri2016@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on mindfulness on quality of life and psychological well-being in woman with cervical cancer
Public title
The effect of counseling based on mindfulness on quality of life and psychological well-being in woman with cervical cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with stage IV cervical cancer
The quality of life score is less than 50%
The psychological well-being score is less than 50
Being married
Have reading and writing skills
Accommodation in Ahvaz city
Ability to speak Persian in order to answer the questionnaire questions
Exclusion criteria:
Drug Addiction
History of Mindfulness Technique
Cause of other acute physical abnormalities
Affected by known psychiatric disorders
Existence of stressful events(Divorce, the death of a family member, the loss of his or her individual job, change in life)Over the past six months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning type of intervention to patients was randomized and random blocked blocks with block size 6 (by Using the table of random permutations)With a ratio of 1: 1
Blinding (investigator's opinion)
Triple blinded
Blinding description
A randomized list is provided by a statistician.
According to a randomized list, codes are assigned by an outside person to any illness that is included in the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd University of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.AJUMS.REC.1397.109
Health conditions studied
1
Description of health condition studied
Cervical Cancer
ICD-10 code
N87
ICD-10 code description
Dysplasia of cervix uteri
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study and one month after the end of the study
Method of measurement
questionnaire
Secondary outcomes
1
Description
Psychological well-being
Timepoint
Before the study and one month after the end of the study
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Mentally educated people
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
mogahi sasan
Street address
Golestan Blvd. Academic town
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8396
Email
montazeri-s@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
montazeri simin
Street address
Golestan Blvd. Academic town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8396
Email
montazeri-s@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
montazeri simin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd. Academic town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8396
Email
montazeri-s@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid Chamran University of Ahwaz
Full name of responsible person
Naser Behrozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Golestan Blvd. Academic town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
behroozyn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
shima bahri
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd. Academic town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
shimabahri2016@yahoo.com
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
Not applicable
Title and more details about the data/document
A portion of the original outcome data will be shared.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
No restrictions.
Under which criteria data/document could be used
Educational and consulting assistance is allowed.
From where data/document is obtainable
shimabahri2016@yahoo.com
What processes are involved for a request to access data/document
Request documentation and data by email and send them in the shortest possible time