Protocol summary

Study aim
Comparing the Effectiveness of Family Care Based on Health Belief Model and Teaching Health Promotion Styles on the Perception of Disease and Physical Symptoms in Patients With Asthma, as Well as Determining the Effectiveness of Family Care Education Based on Health Belief Model and Determining the Rate of Health Promotion Health on the Perception of Disease and the Physical Symptoms of Patients With Asthma.
Design
Controlled Clinical Trial, Not Blind, Randomized Design.
Settings and conduct
At the Fayazbakhsh Hospital, With the Presence of Dr. Jafari, an ََAsthma Specialist, the Patients' Files Were Reviewed and Interviewed. If Satisfied, Patients Complete the Questionnaires in Two Stages: Pre-Test and Post-Test. The Treatment Protocol is Performed in 8 Sessions on the Intervention Group at the Doctor's Clinic.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age Between 40 and 60 Years; Diagnosis of Asthma and no Gender Restriction. Exclusion Criteria: Mental Disorders and Other Pulmonary Diseases.
Intervention groups
The Acceptance and Commitment Group Therapy Protocol (OCT) Will be Administered to the Experimental Group to Change Lifestyle, Health Beliefs, and Perceptions of Illness to Promote Health and Reduce the Physical and Psychological Symptoms of Asthma Patients, and the Control Group Will Continue Their Treatment Had.
Main outcome variables
The Main Implications of This Study are: In the Perception of Disease Questionnaire (Bradbott et al. 2006), and in the Lifestyle Questionnaire (Walker et al. 1987), to Improve Health and Reduce Physical and Mental Symptoms.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200317046802N1
Registration date: 2020-04-12, 1399/01/24
Registration timing: retrospective

Last update: 2020-04-12, 1399/01/24
Update count: 0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Leila Asani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2394 3107
Email address
lasani@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Effectiveness of Family Care Based on Health Belief Model and Education of Health Promotion Lifestyle on illness Perception and Physical Symptoms in Asthma Patients.
Public title
Comparison of The Effectiveness of Family Care Based on Health Belief Model and Education of Health Promotion Lifestyle Acceptance and Commitment Therapy in Asthma Patients.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to Participate in Research Projects, Age Range 30 to 60 Years Have a Minimum of Literacy Be treated for at Least One Year (With the Approval of the Relevant Specialist) Consent to Participate in Research Low Score of Lifestyle Questionnaire and Health Perception Related to Health Promotion
Exclusion criteria:
Kidney and Liver Disease Use of Psychotropic Drugs
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the inclusion criteria and the performance of a pre-test session of 40 individuals who scored lower than the average after completing the Health Belief Forms Questionnaire and Health Promoting Styles Questionnaire and Illness Perception Questionnaire, they were selected by purposeful sampling. Since the study groups are equal in sample size, we use simple random allocation law, which is one of the limited randomization methods, and we divide the individuals into two intervention and control groups. We record patient data on 40 separate sheets and place the sheets inside the draw container and then randomly record 20 sheets out of the intervention group and place the remaining 20 sheets in the control group. To give. If there was a loss in treatment sessions, the sample size would be randomly eliminated in order to equalize the sample size, and eventually the number of subjects in both groups should be the same. Intervention group (n = 20) will have 8 sessions of 120 minutes acceptance and commitment therapy intervention and control group will not receive any intervention.
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 Hormozgan University of Medical Sciences
Street address
Shahid Chamran Blvd., Hormozgan University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.321

Health conditions studied

1

Description of health condition studied
Asthma disease
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Short-Term Form of Disease Perception (Bradbent et al. 2006), Related to Health in Physical and Mental Symptoms.
Timepoint
At the Beginning of the Study (Before the Intervention) and After 8 Sessions of Group Therapy, Acceptance and Commitment.
Method of measurement
Short Scale of Disease Perception (Bradbent et al. 2006), Lifestyle Questionnaire with Health-Related Physical and Mental Symptoms.

Secondary outcomes

1

Description
Lifestyle Score (Walker et al. 1987) Related to Health in Physical and Mental Symptoms.
Timepoint
Scores of Health Promoting Lifestyle Questionnaires (Walker et al. 1987); Illness Perception (Bradbott et al. 2006); at Baseline (Before Intervention) and After Treatment Protocol Implementation.
Method of measurement
Short Form Perceptions Questionnaire (Bradbott et al. 2006); Health Promoting Lifestyle Questionnaires (Walker et al. 1987)

Intervention groups

1

Description
Intervention group: Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: There are 20 asthma sufferers who complete the Health Promoter Questionnaire (Walker et al., 1987) short-form questionnaires (Walker et al., 1987) before completing the protocol, with complete specifications. . In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks.
Category
Behavior

2

Description
Control Group: There are 20 Patients With asthma WHO Complete the Health Promoter (Walker et al. 1987) Shortlisted Test With a Complete List of Specifications in the Pre-Test Questionnaire. This Group has Routine Care For 4 Weeks and no Extra Work is Done on Them. After 4 Weeks, this Group Also Completes the Questionnaires After the Test.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Fayazbakhsh Hospital
Full name of responsible person
Dr. Jafari
Street address
Next to Vitaan factory at the Beginning of Persian Gulf Street ,7 Km of Old Karaj Road
City
Tehran
Province
Tehran
Postal code
1379613541
Phone
+98 21 6625 0465
Fax
+98 21 6625 0743
Email
info@fayazhospital.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Alireza Rosta
Street address
Islamic Azad University of Kish International Branch, Free Zone Organization Squar, Sana'i Blvd.
City
Kish Iland
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Fax
+98 76 4442 3957
Email
Info@IaukishInt.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
En Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Leila Asani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 3 , Kohdayar Alley, Shadman Ave., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
145663464
Phone
+98 21 2394 3107
Email
lasani@iaukishint.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad Sabet
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Rudehen
City
Rudehen
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5891
Fax
+98 21 7650 7665
Email
info@riau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Leila Asani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 3, Khodayar Alley, Shadman Ave., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1456663464
Phone
+98 21 2394 3107
Email
lasani@iaukisint.ac.ir

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
Not applicable
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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