Implementation and evaluation of the virtual training program for behavioral empowerment of family caregivers of patients with chronic pain
Design
Randomized double-blind clinical trial, random allocation will be done with the help of sequence generation software. The study will be conducted on 80 family caregivers.
Settings and conduct
This research will be done in Shiraz Imam Reza (AS) clinic. After obtaining informed consent, the research questionnaires will be completed by the caregivers and their patients and then divided into two intervention and control groups through random allocation.
Participants/Inclusion and exclusion criteria
Entry criteria: the main caregiver of the patient, the patient must have chronic pain for at least 3 years.
Non-entry criteria: diagnosis of cancer or any other chronic disease other than pain in patients during the study, unwillingness to continue participating during the study.
Intervention groups
In this study, a program for behavioral empowerment of family caregivers of patients with chronic pain will be implemented. For this purpose, the content of the program will be sent to the caregivers of the intervention group through electronic modules through virtual networks. Also, telephone follow-ups and individual consultations will be carried out by the researcher's assistant for these people, and the control group will not receive any training.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240630062283N1
Registration date:2024-08-10, 1403/05/20
Registration timing:prospective
Last update:2024-08-10, 1403/05/20
Update count:0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Sahar Khaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4252 9274
Email address
saharkhaki136@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementation and evaluation of the virtual training program for behavioral empowerment of family caregivers of patients with chronic pain
Public title
"Evaluation of the effect of educational-psychological support interventions on family caregivers of patients with chronic pain"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Entry conditions for family caregivers of patients with chronic pain and their patients:
- Literacy in reading, writing and speaking in Persian language
- According to the doctor's diagnosis, the patient has had chronic pain for at least 3 years
-Having a smart mobile phone and the ability to work with it
- A caregiver who has been taking care of the patient for the past 3 months and lives with the patient.
- Willingness to participate in the study
Exclusion criteria:
Exclusion criteria of family caregivers of patients with chronic pain and their patients from the study:
- Unwillingness to continue participating during the study
- The occurrence of unfortunate events for relatives of caregivers and patients (severe mental or physical illness) and events such as accidents, divorce, death, etc.) during the study
- Caregiver participating in psychotherapy programs or receiving psychological counseling in the last 6 months
- Diagnosis of cancer or any other chronic disease other than pain in patients during the study
- Hospitalization of the patient and receiving psychological interventions during the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Family caregivers of patients with chronic pain and their patients will be selected from the pain clinic department of Imam Reza (AS) hospital affiliated to Shiraz University of Medical Sciences and Health Services and will be assigned to groups by the method of extracting envelopes from inside the container. In this way, at first, two separate groups will be considered as group A (intervention) and group B (control). Each person will be placed in A and B groups randomly by drawing an envelope with one of the two letters A or B written inside. Caregivers and their patients will remain in the same group during all training sessions.
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 Shiraz University of Medical Sciences
Street address
7 Tir Boulevard, Golestan 3
City
Noorabad
Province
Fars
Postal code
7351817353
Approval date
2023-01-07, 1401/10/17
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.107
Health conditions studied
1
Description of health condition studied
chronic pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Caregivers' quality of life
Timepoint
before the start of the intervention, immediately after the end of the intervention and three months after the end of the intervention.
Method of measurement
پرسشنامه کیفیت زندگی مراقبین وار و شربون
2
Description
Caregiver general self-efficacy
Timepoint
before the start of the intervention, immediately after the end of the intervention and three months after the end of the intervention.
Method of measurement
Scherer and Maddox general caregiver self-comedy questionnaire
3
Description
Caring load, careful
Timepoint
before the start of the intervention, immediately after the end of the intervention and three months after the end of the intervention.
Method of measurement
Questionnaire of caregiving burden, caregiving Novak and Gast
Secondary outcomes
1
Description
Quality of life of patients with chronic pain
Timepoint
before the start of the intervention, immediately after the end of the intervention and three after the end of the intervention.
Method of measurement
World Health Organization Quality of Life Questionnaire
2
Description
Pain-induced self-efficacy of patients with chronic pain
Timepoint
before the start of the intervention, immediately after the end of the intervention and three after the end of the intervention.
Method of measurement
Nicholas' pain self-efficacy questionnaire
3
Description
Pain-induced disability in patients with chronic pain
Timepoint
before the start of the intervention, immediately after the end of the intervention and three after the end of the intervention.
Method of measurement
Questionnaire of disability due to pain in patients with chronic pain Roland and Morris
Intervention groups
1
Description
Intervention group: The electronic content will be available to family caregivers in a period of 8 weeks. This content includes training manuals for caring for patients with chronic pain, understanding the multiple impact of the disease on caregivers' lives, familiarizing caregivers with the nature and characteristics of chronic pain, stress and anxiety management, depression management, and a number of audio and video clips for improvement. Solving the problem will be solutions to increase resilience, manage social family relationships, manage anger control, physical and cognitive strategies to control pain and improve courage skills. Also, weekly follow-ups and giving psychological and educational counseling for people if needed. will be executed. This work will continue for 8 weeks from the day of the intervention. Before the intervention, immediately after the end of the intervention and 3 months after the end of the intervention, the research questionnaires will be completed.
Category
Behavior
2
Description
Control group: Before the intervention, immediately after the end of the intervention and 3 months after the end of the intervention, the research questionnaires will be completed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic (AS)
Full name of responsible person
Nima Fadakar
Street address
Shiraz, Namazi Square, next to blood transfusion, Imam Reza (a.s.) specialized and sub-specialized clinic.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
emamreza@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand St, Shiraz Townt
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 7883
Fax
Email
vcrdep@sums.ac.ir
Web page address
http://www.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Maryam Shaygan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College, Namazi Sq, Zand St, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 4254 3647
Email
m2620.shaygan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sahar Khaki
Position
PhD nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shiraz, Zand Street, Namazi Square, Faculty of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 4254 3647
Email
saharkhaki136@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sahar Khaki
Position
PhD nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shiraz, Zand Street, Namazi Square, School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 4254 3647
Email
saharkhaki136@gmail.com
Web page address
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
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
Only part of the data includes the main and secondary consequences of sharing.
When the data will become available and for how long
Starting the course of access 4 months after printing the article
To whom data/document is available
Researchers working in medical and academic centers
Under which criteria data/document could be used
This data can be used only for research purposes.
From where data/document is obtainable
They can send a message to the following electronic address and submit their request: saharkhaki136@gmail.com
What processes are involved for a request to access data/document
Upon submission of the application email, the applicant must submit his or her documentation to the researcher (educational and research purposes). After approval by the researcher, the data will be available within a week.