Protocol summary

Study aim
Determining the effect of Happiness Educational Program of Fordyce on the sense of coherence and psychological well-being of adolescents who have a parent with cancer
Design
Field trial with a control group, with parallel groups, randomized, 92 people
Settings and conduct
Approval of the research plan in the university ethics committee. Selection of research units if they have a child in the research age group in the morning and evening shifts in the oncology ward of Shahid Rajaei Hospital. Obtain informed consent. Completion of the demographic checklist, Antonovsky's Sense of Coherence Questionnaire-13 and the Ryff's scale of Psychological well-being-18 at the beginning. For the intervention group, the number of sessions will be 6 sessions of 60 minutes and one day a week for 6 weeks. At the end of the research intervention, the Antonovsky's Sense of Coherence Questionnaire-13 and the Ryff's scale of Psychological well-being-18 are completed by both intervention and control groups. The place of training will be a room to protect the privacy of teenagers in Shahid Rajaei Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Consent to participate in the study and sign the informed consent form by the parent and adolescent 2. At least six months have passed since the definitive diagnosis of parent cancer by an oncologist. Criteria for non-inclusion: 1. Lack of adolescent awareness of parental cancer 2. History of participation in similar training courses in the last six months
Intervention groups
The number of sessions in the intervention group will be 6 sessions of 60 minutes and one day a week for 6 weeks. The interventions will be performed in groups and in groups of 5 to 10 people. Control group: Non-intervention: This training group will not be given.
Main outcome variables
Sense of Coherence and Psychological well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210331050795N1
Registration date: 2021-06-21, 1400/03/31
Registration timing: prospective

Last update: 2021-06-21, 1400/03/31
Update count: 0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Raziye Forutan nasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 2524
Email address
razie2624@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Happiness Educational Program of Fordyce on the sense of coherence and psychological well-being of adolescents who have a parent with cancer
Public title
The effect of Happiness Educational Program of Fordyce on the sense of coherence and psychological well-being of adolescents who have a parent with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study and sign the informed consent form by the parent and adolescent One of the parents has cancer At least six months have passed since the definitive diagnosis of parental cancer by an oncologist Simultaneously obtaining a score of 52 or less in the Antonovsky's Sense of Coherence Questionnaire-13 and Ryff's scale of Psychological well-being-18
Exclusion criteria:
Lack of adolescent awareness of parental cancer Simultaneous infection of a teenager or a first-degree member of his family with other incurable diseases Simultaneous infection of a teenager or a first-degree member of his family with mental illness Both parents have cancer History of participating in similar training courses in the last six months
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment of a block will be such that first by multiplying the number of groups studied (two groups) by 2, the number of samples of each block is calculated equal to 4, then by factorial calculation, the number of samples of each block (4! = 4 × 3 × 2 × 1= 24), the number of blocks resulting from all states of arrangement of individuals, 24 calculated blocks and blocks involving the possible arrangement of individuals considering A (gray manikin) for the intervention group and B (white manikin) for the control group will be. Then, since the number of people in each block is 4 people and the estimated sample size is 92 people, so by matching 18 random numbers produced by Sample Randomizer software with the number of the above cases, how to arrange 92 people research sample and assign each number from 1 to 92 to one of the specific intervention or control groups and a block random allocation list will be compiled. Eligible research samples, based on the time priority of the referral, will be assigned a code to each of them, by matching that number with the block random allocation list, the adolescents participating in the research will be assigned to one of the intervention or control groups. This process will continue until the estimated sample size is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2021-06-02, 1400/03/12
Ethics committee reference number
IR.YUMS.REC.1400.050

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C80.0
ICD-10 code description
Malignant neoplasm, without specification of site

Primary outcomes

1

Description
Sense of Coherence
Timepoint
Adolescents' sense of Coherence at the beginning of the study (before the intervention) and immediately after the start of the study
Method of measurement
Antonovsky's Sense of Coherence Questionnaire-13

2

Description
Psychological well-being
Timepoint
Adolescents' psychological well-being at the beginning of the study (before the intervention) and immediately after the start of the study
Method of measurement
Ryff's scale of Psychological well-being-18

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The number of sessions in the intervention group will be 6 sessions of 60 minutes and one day a week for 6 weeks. The interventions will be performed in groups and in groups of 5 to 10 people. The Fordyce Happiness training program will be implemented by the researcher using the methods of lectures, group discussions, questions and answers, and thoughts. The following will be briefly mentioned in 6 sessions: Session 1: Defining happiness, its necessity and importance, Session 2: Training to spend more time in communities and group activities, Session 3: Principles of better planning and organization, Session Fourth: Teaching the principles of positive and optimistic thinking, Session 5: Teaching the principles of cultivating social and extroverted personality and Session 6: Teaching the principles of sincere communication as the most important source of happiness.
Category
Lifestyle

2

Description
Control group: Non-intervention: This training group will not be given.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Razieh Forutannasab
Street address
Shahid Rajaei Hospital, facing the governor's office, Imam Hossein Square, Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591873118
Phone
+98 74 3222 4711
Email
rajaeey@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 3333 7230
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Razieh Forutannasab
Position
Master Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Sub-Branch 7, Ibn Sina St., Terminal
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591961919
Phone
+98 74 3322 2524
Email
razie2624@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Razieh Forutannasab
Position
Master Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Sub-Branch 7, Ibn Sina St., Terminal
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591961919
Phone
+98 74 3322 2524
Email
razie2624@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Razieh Forutannasab
Position
Master Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Sub-Branch 7, Ibn Sina St., Terminal
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591961919
Phone
+98 74 3322 2524
Email
razie2624@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
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