Determining the effect of virtual training of cognitive therapy based on mindfulness on pain intensity and quality of life of women undergoing breast cancer treatment
Design
A clinical trial with a control group, randomized, on 54 patients, was used for randomization using four permutation blocks
Settings and conduct
Eligible participants will be randomly divided into two test and control groups and entered into the study.
Research questionnaires are designed virtually. Before the educational intervention, the Arnson Quality of Life Questionnaire, the brief Cleveland Pain Severity Questionnaire, and the demographic information form will be completed virtually by all subjects in both groups.
In the control group, no action is taken, and the test group is subjected to the intervention of cognitive therapy training based on mindfulness in virtual form during 8 sessions of 90 minutes (once a week) in the form of lectures and questions and answers. One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Diagnosis of breast cancer (phase I and II)
2- Age range between 18 and 60 years
3-Consent to participate in the study
4- Ability to read and write
5- Absence of speech, hearing and vision problems
6-Access to social networks
7- Absence of active mental disorder
Exit criteria:
1-Diagnosis of metastatic breast cancer
2- Patient withdrawal from the study
3- Absence of more than two sessions in training sessions
Intervention groups
All women undergoing breast cancer treatment referred to Seyed al-Shohda Hospital in Isfahan city
Main outcome variables
People's scores in Arnson's Quality of Life Questionnaire and Cleveland Brief Pain Intensity Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230620058544N1
Registration date:2023-06-27, 1402/04/06
Registration timing:prospective
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Arefeh Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
arefehebrahimi4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-22, 1402/04/31
Expected recruitment end date
2023-08-05, 1402/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual training of mindfulness based cognitive therapy on pain severity and quality of life in women treated with breast cancer
Public title
The effect of virtual training of mindfulness based cognitive therapy on pain severity and quality of life in women treated with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1-Diagnosis of breast cancer (phase I and II) 2- Age range between 18 and 60 years 3-Consent to participate in the study 4- Ability to read and write 5- Absence of speech, hearing and vision problems 6-Access to social networks 7- Absence of active mental disorder
Exclusion criteria:
1-Diagnosis of metastatic breast cancer based on the opinion of an oncologist 2-Patient withdrawal from the study 3-Absence of more than two sessions in educational sessions
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in an easy and purpose-based way according to the criteria for entering and exiting the research community. People will be selected from among the women undergoing primary breast cancer treatment in Isfahan treatment centers who meet the entry criteria, and then they will be randomly assigned to the intervention and control groups using four permutation blocks. Six possible states (BABA, ABBA, BAAB, AABB ABAB, BBAA) are listed and by throwing a dice, the number of blocks will be randomly selected until a sufficient number of samples, and people will be placed in two intervention (A) and control (B) groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Type of study: randomized clinical trial with a pre-test-post-test design with a control group. First, people will be randomly divided into two test and control groups and will enter the study. Both groups complete the quality of life and pain intensity questionnaire before the intervention. No action is taken in the control group and the experimental group is subjected to the intervention of cognitive therapy training based on mindfulness. One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Side of the Asian road,Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.GMU.REC.1402.045
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
People's scores in Arnson's quality of life questionnaire
Timepoint
Checking the quality of life of the participants before the intervention and one week after the end of the intervention
Method of measurement
Arnson quality of life questionnaire
2
Description
People's scores in the Brief Cleveland Pain Intensity Questionnaire
Timepoint
Examining the pain intensity of the participants before the start of the intervention and one week after the end of the intervention
Method of measurement
Brief Cleveland Pain Intensity Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the start of the intervention, the virtual questionnaire of quality of life and brief pain intensity questionnaire will be completed by the test and control group. The test group is subjected to the intervention of cognitive therapy training based on mindfulness in virtual form during 8 sessions of 90 minutes (once a week) in the form of lectures and questions and answers. The first and last meeting will be held online on the Zinomite platform, and other meetings will be held offline through the formation of a group on the Yes social network in the form of sending a video. Also, in order to provide guidance and answer the questions of the participants, audio and video calls will be made during the week.he training program consists of two parts: a training course provided by the researcher (after training under the supervision of an experienced psychologist in mindfulness interventions), the other is a 45-minute home exercise (after each virtual session for 6 days a week). One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared.
Category
Other
2
Description
Control group: Before the start of the intervention, the virtual questionnaire of quality of life and brief pain intensity questionnaire will be completed by the test and control group. There is no intervention on the control group. One week after the intervention, both the test group and the control group completed the quality of life and pain intensity questionnaire again and were compared. Finally, in order to comply with the ethical principles, the people in the control group who want individual counseling will receive the training program.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al-Shohda Hospital
Full name of responsible person
Arefeh Ebrahimi
Street address
Nehar Farshadi Alley, Khayyam St, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8431967181
Phone
+98 31 3235 0210
Email
arefehebrahimi4@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Leila Sadegh Moghadam
Street address
Gonabad University of Medical Sciences, Side of the Asian road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3401
Email
hms@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Arefeh Ebrahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side of the Asian road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5723 6160
Email
arefehebrahimi4@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Arefeh Ebrahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side of the Asian road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5723 6160
Email
arefehebrahimi4@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Arefeh Ebrahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side of the Asian road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5723 6160
Email
arefehebrahimi4@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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