Comparing the effect of two educational methods; Family-centered and traditional empowerment model on adherence to treatment and perceived social support in patients undergoing Bariatric surgery
Determining the effect of two educational methods; family-centered and traditional empowerment model on adherence to treatment and perceived social support in patients undergoing bariatric surgery
Design
A randomized controlled clinical trial
Settings and conduct
The study will be conducted in 3 sessions. The first session will be held at the time of the patient's visit to the hospital for surgery case compilation; the second session will be held three weeks before the surgery; the third session will be held 15 days before surgery . The meetings will be actively attended by the patient and family members or the primary caregiver. In these sessions, under the management of the researcher, discussions and questions and answers about adherence to treatment and its importance will be discussed. These sessions will be held in the Obesity Clinic of Madar va Koodak Ghadir Hospital in Shiraz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having full consent to enter the study; being a candidate of Bariatric surgery; the family member (caregiver and main companion) have at least diploma
Exclusion criteria: having disorders related to treatable endocrine glands; having alcohol or drug addiction; being afflicted with a severe and well-known mental illness
Intervention groups
In the intervention group, the anticipated steps of the family-centered empowerment model will be implemented, which include the perceived threat step, the problem-solving step, and the educational participation step in three 1-hour sessions.
During the research, the researcher will be in contact with the patient through social networks and telephone to resolve ambiguities and possible questions.
The control group follows the normal routine of the hospital.
Main outcome variables
Adherence to treatment, perceived social support
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039802N3
Registration date:2020-12-13, 1399/09/23
Registration timing:prospective
Last update:2020-12-13, 1399/09/23
Update count:0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Zahra Sobhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9711
Email address
zahrasobhani120@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two educational methods; Family-centered and traditional empowerment model on adherence to treatment and perceived social support in patients undergoing Bariatric surgery
Public title
The effect of implementing family-centered empowerment model on adherence to treatment and perceived social support
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Complete consent to study
candidate for Bariatric surgery
family member (primary caregiver) with minimum diploma literacy
Exclusion criteria:
Having treatable endocrine disorders
Alcohol or drug addiction
With severe and well-known mental illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: Based on the formula of sample size comparison of two means with an error of 5%, with a power of 90% and using the results of a similar study, the sample size in each group was calculated at least 18 people.
Which was taken to increase the accuracy of 20 patients in each group. Accordingly, 80 patients who meet the inclusion criteria are randomly divided into two groups of 20 with block randomization (with the size of each block equal to 4). The randomization list is generated and used using random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The objectives of the research will be explained to the participants. Neither the participants in the experimental group know that there is a control group nor the participants in the control group know that there is an experimental group. Also, the groups are not related to each other. The health care staff of the obesity clinic who are responsible for caring for patients, data collectors, and those evaluating the outcome are also blind and will not be informed of the objectives of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
ُShiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.SUMS.REC.1398.515
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Adherence
Timepoint
At baseline and 3 months and 6 months after surgery
Method of measurement
Treatment Compliance Questionnaire
2
Description
perceived social support
Timepoint
At baseline and 3 months and 6 months after surgery
Method of measurement
Perceived Social Support Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Session 1: Perceived threat step. In this session, issues about surgery and its process, complications, risk factors and effects of defects and failures in the treatment plan, methods of prevention and control of complications, self-care behaviors (adherence to diet, medication, exercise regime) and its importance is explained in simple language to patients and their caregivers. Patients' questions will then be discussed and answered. Session 2: Problem-solving step.This meeting will be held aimed at problem-solving. The problem-solving steps include diagnosing the problem, explaining the goals, providing solutions, and selecting the best solution. Discussion on how to choose and implement the best solution to achieve the desired goals according to the ability of the patient and the family, will be the focus of this meeting. At this stage, the skills needed to achieve the goal will be taught (physical exercise, fixing the meal time to prevent reflux and dumping syndrome). Booklets and pamphlets will also be provided to the patient and family. A patient who has undergone surgery and achieved the best postoperative results will also be invited to help provide solutions. Session 3: Educational Participation step. In this session, the patient himself/herself assists the researcher in educating other patients and families. This participation will be done to increase the patient's self-confidence and gain family support. During the research, the researcher will be in contact with patients through social networks and telephone to resolve ambiguities and possible questions. Each session will last for one hour and the last session will be held at least 15 days before surgery.
Category
Lifestyle
2
Description
Control group: The 40-person group will go through the routine procedures of the hospital and will receive routine training.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Shiraz Mother and Child Hospital
Full name of responsible person
Zinat Mohebi
Street address
Mother and Child Hospital، Beginning of Golshan Town، Shiraz Above the Quran Gate
City
Shiraz
Province
Fars
Postal code
7144995377
Phone
+98 71 3227 9721
Email
motherhosp@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Qasemi
Street address
Zand Street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1453
Email
colorectal@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sobhani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 5, Moalem Street
City
Shiraz
Province
Fars
Postal code
7186837152
Phone
+98 71 3631 9937
Email
zahrasobhani120@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sobhani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 5, Moalem Street
City
Shiraz
Province
Fars
Postal code
7186837152
Phone
+98 71 3631 9937
Email
zahrasobhani120@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sobhani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 5, Moalem Street
City
Shiraz
Province
Fars
Postal code
7186837152
Phone
+98 71 3631 9937
Email
zahrasobhani120@yahoo.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