Determining the Effect of Positive Thinking Skill Training on Life Expectancy and Self-esteem in Patients Undergoing Chemotherapy
Design
This research will be quasi -experimental with a pre-test, post-test design with a control group. Patients will be randomly allocated into two control and intervention groups.In the current study, the sample size was 30 people.
Settings and conduct
The statistical population includes all patients undergoing chemotherapy in Mehr Iran Hospital, Birjand city in 2023. First, a pre-test will be conducted to evaluate the average level of self-esteem using the Rosenberg questionnaire and the average life expectancy using the Schneider questionnaire in two groups. The intervention group will receive positive thinking training in 8 30-minute sessions (twice a week) using the educational protocol taken from the Positive Psychotherapy book (Seligman) and counseling with psychology professors. After the completion of the intervention (8 training sessions), the average self-esteem and life expectancy in both control and intervention groups will be measured and monitored with the same questionnaires. In order to consider ethical principles, at the end of the intervention, positive thinking skill training booklets will be given to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: written informed consent; history of chemotherapy for at least one month; age 18-60 years old. Exclusion criterion: missing more than two sessions.
Intervention groups
The intervention group will receive positive thinking training in 8 30-minute sessions (twice a week) using the training protocol taken from the Positive Psychotherapy book (Seligman) . During this period, the control group does not receive training.
Main outcome variables
Life Expectancy and Self-esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240204060898N1
Registration date:2024-02-20, 1402/12/01
Registration timing:registered_while_recruiting
Last update:2024-02-20, 1402/12/01
Update count:0
Registration date
2024-02-20, 1402/12/01
Registrant information
Name
Elham Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3204 8216
Email address
elhamramezani@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-03-14, 1402/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Positive Thinking Skill Training on Life Expectancy and Self-Esteem in Patient Undergoing Chemotherapy
Public title
The Effect of Positive Thinking Skill Training on Life Expectancy and Self-Esteem in Patient Undergoing Chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent
History of chemotherapy for at least 1 month
Doing chemotherapy during training sessions
Attend all training sessions
Age between 18 and 60 years
Having at least reading and writing literacy
Exclusion criteria:
Not taking psychotropic drugs for at least three months before and during the training course
Not having severe neurological disorders based on participants' self-report
Not using other complementary medicine treatments one month before and during the treatment
Not participating in the same course (face-to-face, virtual)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The random block method will be as follows:
1)The size of each block will be 4.
2)All possible combinations will be written with 2 control and 2 intervention cases. (6 combinations)
3)Blocks are randomly selected to allocate all of participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after sampling and before random allocation, the participants are told that the positive thinking skill will be provided in the form of face-to-face training or educational pamphlets.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
97117853076
Approval date
2024-02-03, 1402/11/14
Ethics committee reference number
IR.BUMS.REC.1402.481
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
2
Description of health condition studied
Cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
3
Description of health condition studied
Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
4
Description of health condition studied
Cancer
ICD-10 code
C94
ICD-10 code description
Other leukemias of specified cell type
5
Description of health condition studied
Cancer
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri
Primary outcomes
1
Description
Life Expectancy Score in Schneider Questionnaire
Timepoint
Before the Start of the Intervention and After the End of the Intervention
Method of measurement
Schneider Life Expectancy Questionnaire
2
Description
Self-Esteem Score in the Rosenberg Questionnaire
Timepoint
Before the Start of the Intervention and After the End of the Intervention
Method of measurement
Rosenberg Self-Esteem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention group will receive positive thinking training in 8 30-minute sessions (twice a week) using the educational protocol taken from the Positive Psychotherapy book (Seligman) and counseling with psychology professors.
Category
Rehabilitation
2
Description
Control group: At the end of the intervention, positive thinking skill training booklets will be given to the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
IRAN MEHR Radiotherapy and Oncology Center
Full name of responsible person
Dr. Hassan Mortazi
Street address
30 th Ghafari Ave., Ghafari Blvd.,
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3162 6800
Email
iranmehr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Masoud Yousefi
Street address
Ghafari Blvd.,Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
webda@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Elham Ramezani
Position
Psychiatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, South Khorasan, Iran
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
elhamramezani0135@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fatemeh Biyabani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghafari Blvd.,Birjand University of Medical Sciences
City
Birhand
Province
South Khorasan
Postal code
97178553076
Phone
+98 56 3239 5000
Email
arashniya2012@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Elham Ramezani
Position
Psychiatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, South Khorasan, Iran
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
elhamramezani0135@gmail.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
Based on Ethical Issues
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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