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The Effect of Johnson's Behavioral Theory on the Anxiety and Self-efficacy of Mothers of Children with Cancer

Protocol summary

Study aim
Determining the Effect of Johnson's Behavioral Theory on the Anxiety and Self-Efficacy of Mothers of Children with Cancer Hospitalized in Ayatollah Taleghani Hospital in Gorgan
Design
Experimental study with control group, with parallel groups, double-blind, randomized on 66 patients
Settings and conduct
A Classical Experimental Study of Johnson's Behavioral Theory on Anxiety and Self-Efficacy of Mothers of Children with Cancer Hospitalized at Ayatollah Taleghani Hospital in Gorgan, which is Randomly divided into Two Groups: Test and Control. After taking the Pre-Test from both Groups, 6 Training Sessions are Performed in the Test Group, then at the End, both Groups are taken after the Test.
Participants/Inclusion and exclusion criteria
Admission: Having at least one child with cancer - Ability to participate in training and learning classes, mother's desire to participate in the study Failure to enter: illiterate mother, possibility of child death
Intervention groups
Before the Intervention begins, in both the Test and Control Groups, Speilberger's Anxiety and Self-Efficacy Questionnaires for the Two People in the Study will be Completed. In the Test Group, based on Johnson's Behavioral Theory, the Educational Content will be Presented in 6 Sessions, 45-Minute in Groups of 5-6 People for Twice a Week, then the Questionnaires will be Completed by the Test and Control Group
Main outcome variables
Reducing Anxiety and Mothers in Caring for a Child with cancer; Increasing Mothers' Self-Efficacy in Caring for their Child with Cancer; Reduce Anxiety and Increase Maternal Self-Efficacy Through Johnson's Behavioral Model

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200612047741N1
Registration date: 2020-10-14, 1399/07/23
Registration timing: registered_while_recruiting

Last update: 2020-10-14, 1399/07/23
Update count: 0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Sahar Paryab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3234 1264
Email address
saharparyab139@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Johnson's Behavioral Theory on the Anxiety and Self-efficacy of Mothers of Children with Cancer
Public title
Johnson's Theory of the Anxiety and Self-efficacy of Mothers of Children with Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one Child with Cancer Statement of Desire to Participate in Research Ability to Participate in Training Classes and Learn Content
Exclusion criteria:
Lack of mother education Reluctance to participate in the study
Age
From 1 year old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, mothers of children with cancer with inclusion criteria were first selected to participate in the study. Then, for random division of individuals into control and intervention groups, sealed sheets containing the type of group therapy will be used. For this purpose, all the sheets are placed in a box and the mother will choose one of the sheets after entering the study. Next, the researcher will assign the educational method to the mother according to the type of group therapy mentioned in the sheet. It should be noted that half of the sheets in the box belong to the intervention group and half belong to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Chalous Branch
Street address
17 Shahrivar St.
City
Chalous
Province
Mazandaran
Postal code
46615/397
Approval date
2020-09-13, 1399/06/23
Ethics committee reference number
IR.IAU.CHALUS.REC.1399.010

Health conditions studied

1

Description of health condition studied
Anxiety and self-efficacy of mothers of children with cancer
ICD-10 code
G99
ICD-10 code description
Other disorders of the nervous system

Primary outcomes

1

Description
Controlling anxiety and increasing mothers' self-efficacy based on a questionnaire
Timepoint
Before the intervention, in both experimental and control groups, the Spielberger Anxiety Inventory and Domkai Self-Efficacy Questionnaire will be completed by the subjects. Then the test on separate days for six sessions in a period of 45 minutes (total 225 minutes) with the content of the theory of behavioral Johnson will be held after the end of training sessions two months later, on separate days this to post-test questionnaires by two groups And controls will be completed
Method of measurement
Anxiety and self-efficacy are measured based on the Spielberger Anxiety Questionnaire and Domkai self-efficacy questionnaire before the intervention and after six sessions of intervention in the intervention group during the two months of intervention in both control and intervention groups.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, in the intervention group, before the intervention, we measure the level of anxiety and self-efficacy using the Spielberger Anxiety Questionnaire and Dumkai self-efficacy questionnaire, then the intervention is divided into six sessions, respectively: Due to the discomfort and frustration of your child and how to deal with it, prevent the child from withdrawing and establish a cordial environment for the child and family and teach good behavior to the child, Session 3: Teaching about protection against fever infection Ways to prevent it Adherence to it and proper diet and how to store energy and prevent fatigue and participation in energy recovery, balance between activity and rest, Session 4: Training on how to prevent damage to the rectal membrane and rectal hygiene Training on how to prevent anorexia Oral hygiene to prevent stomatitis (at the end of the fourth session, the training package will be delivered to mothers), the fifth session: reviewing with mothers and answering questions and the sixth session: re-completing the questionnaires and the duration of each session was 45 and the total time period The intervention is one month.
Category
Treatment - Other

2

Description
Control group: In this study, the control group baseline level of anxiety and self-efficacy using the Spielberger Questionnaire and self-Dvmkay measurements are then finally complete this questionnaire in the control group a month later re-measure the level of anxiety and We measure self-efficacy in two groups.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital in Gorgan
Full name of responsible person
Hamid Hojjati
Street address
Aliabad
City
Aliabad
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 2300
Email
H_Hojjati1362@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azadeh Sadat Naeemi
Street address
Aliabad
City
Aliabad
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3432 2300
Email
h_hojjati1362@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Chalous Branch
Proportion provided by this source
1
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojjati
Position
Hamid Hojjati
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Aliabad
City
Aliabad
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 2300
Email
h_hojjati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojjati
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Aliabad
City
Aliabad
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3423 2200
Email
h_hojjati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojjati
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Aliabad
City
Aliabad
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 2300
Email
h_hojjati@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Data are collected using a questionnaire in two groups of intervention and control before the intervention, then the desired intervention is performed. After the intervention, the data are collected again using a questionnaire on how to publish data. Results before and after the intervention From the intervention in both groups, the intervention and control are published separately using the mean and frequency, but individual data can not be published.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Only academics can access the study
Under which criteria data/document could be used
All documents are accessible
From where data/document is obtainable
Individuals can call Dr. Hamid Hojjati (09113701106- H_hojjati1362@yahoo.com), Sahar Paryab (09114473609, saharparyab139@gmail.com) to receive information, respectively.
What processes are involved for a request to access data/document
After the results of the data by other researchers to question the doctor Hamid proof and Sahar Paryab and academic qualifications of the person being checked and documented and offered their services
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