Determining the impact of spirituality-based palliative care training on quality of life, death anxiety and resilience in heart failure patients
Design
The present study will be a randomized clinical trial without blinding. At first, 80 patients will be selected as convenience and then randomly allocated. Three variables of quality of life, death anxiety and resilience will be investigated before, immediately and three months after the educational intervention based on palliative care based on spirituality for two intervention and control groups. The training will be conducted through six one-hour sessions in the form of group discussions, training pamphlets, lectures and training PowerPoint for the intervention group. The control group will only receive the training package and will not receive the training intervention.
Settings and conduct
The present study will be a randomized clinical trial without blinding. The target population in this study will be heart failure patients referring to Vali Asr Fasa Hospital
Participants/Inclusion and exclusion criteria
80 patients with heart failure will first be selected via convenience sampling and then randomly divided into intervention and control groups. inclusion criteria included heart failure class 1 to 3, being literate, not having acute and chronic mental and psychological diseases and Age is between 30 and 55 years. Exclusion criteria included worsening of the disease condition، death of the patient and withdrawal from the study for any reason.
Intervention groups
The training will be conducted through six one-hour sessions in the form of group discussions, training pamphlets, lectures and educational PowerPoint for the intervention group.
Main outcome variables
Quality of life, death anxiety, resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N7
Registration date:2022-12-05, 1401/09/14
Registration timing:registered_while_recruiting
Last update:2022-12-05, 1401/09/14
Update count:0
Registration date
2022-12-05, 1401/09/14
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-10, 1401/08/19
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spirituality-based palliative care training on quality of life, death anxiety and resilience in heart failure patients
Public title
The effect of spirituality-based palliative care training on quality of life, death anxiety and resilience in heart patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Class 1 to 3 heart failure
Having literacy
Not having acute and chronic mental and psychological diseases
Age between 30 and 55 years
Exclusion criteria:
Worsening of the disease
death of the patient
Withdrawal from the study for any reason
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
40
40 patients in the intervention group and 40 patients in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
80 patients with heart failure will be selected as available and then randomly divided into intervention and control groups. For the purpose of random allocation, 80 cards were placed inside a sealed envelope and the patients were asked to randomly pick one card. Patients who take card A are in the intervention group and patients who take card B are in the control group.
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 Fasa University of Medical Sciences
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2022-10-19, 1401/07/27
Ethics committee reference number
IR.FUMS.REC.1401.112
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Quality of life
Timepoint
Before, immediately and three months after the educational intervention
Method of measurement
Minnesota Quality of Life Questionnaire
2
Description
Resilience
Timepoint
Before, immediately and three months after the educational intervention
Method of measurement
Connor-Davidson Resilience Questionnaire
3
Description
death anxiety
Timepoint
Before, immediately and three months after the educational intervention
Method of measurement
Templer Death Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The training will be conducted through six one-hour sessions in the form of group discussions, educational pamphlets, lectures and educational PowerPoint for the intervention group.
Category
Lifestyle
2
Description
Control group: The control group will only receive the training package and will not receive the training intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
Full name of responsible person
Mostafa Bijani
Street address
Ibn Sina Square. Fasa University of Medical Sciences.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Yasser Mansouri
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
Mansouri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After completing the study and publishing the results, by requesting the use of the study process and the use of questionnaires, as well as the content of the training program, the author in charge of the documentation will be shared.
When the data will become available and for how long
After completing the study and publishing the results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
After completing the study and publishing the results, by requesting the use of the study process and the use of questionnaires, as well as the content of the training program, the author in charge of the documentation will be shared.
From where data/document is obtainable
Send a request to use documents to the responsible author via email
What processes are involved for a request to access data/document
ending the request for the use of documents to the responsible author via email and sending the documents requested by the responsible author to the requesting person.