Determining the effect of spiritual therapy on hope and self-efficacy of hemodialysis patients
Design
A randomized clinical trial with two intervention and control groups, blinded,
Settings and conduct
Randomized, blind clinical trial, in Imam Reza Amol Hospital
Participants/Inclusion and exclusion criteria
Entrance criteria: Age at least 18 years old; at least 6 months of hemodialysis history; at least twice weekly hemodialysis; reading and writing comprehension; ability to understand Persian language; lack of obvious cognitive problems, including Alzheimer's, no stroke and transient brain attack, not known vision and hearing related diseases; lack of mental disorders, belief in one of the divine religions. Exit criteria: crisis incident after the start of the study; hospitalized because of relapse of the disease; having a chronic illness that reduces the function; death of the patient.
Intervention groups
Intervention group: The intervention group was treated individually 2 times a week and included 9 sessions of 45 minutes each patient. One month after the sessions, the participants were appreciated in the post-test. Therapeutic spirituality sessions include: Identify and contextualize the spiritual experience, introspection and description, sources of fear and anxiety, and our resources against them, endlessness and inheritance, inheritance on the orbit of the circuit and inheritance on Kine's circuit, meditation and calculation, forgiveness And solving the anger, self-control, and reflection of self-sustaining sessions. Control group: Only received routine care
Main outcome variables
Increased hope and self-efficacy in patients undergoing hemodialysis
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20181213041957N1
Registration date:2019-02-17, 1397/11/28
Registration timing:retrospective
Last update:2019-02-17, 1397/11/28
Update count:0
Registration date
2019-02-17, 1397/11/28
Registrant information
Name
peiman fereidouni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3423 8444
Email address
peimanfereidounisa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-26, 1397/08/04
Expected recruitment end date
2019-01-01, 1397/10/11
Actual recruitment start date
2018-10-26, 1397/08/04
Actual recruitment end date
2019-01-01, 1397/10/11
Trial completion date
2019-01-30, 1397/11/10
Scientific title
Investigating the effect of Spiritual therapy approach on hope and self-efficacy in hemodialysis patients
Public title
Investigating the effect of Spiritual therapy approach on hope and self-efficacy in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age at least 18 years old
Having at least six months of hemodialysis history
Having at least twice a week hemodialysis
Reading and writing skills
Ability to understand Persian language
Lack of obvious cognitive problems, including Alzheimer's, non-stroke, and transient Brain attack
Lack of known vision and hearing ailments, not afflicted with mental disorders approved by the doctor
Belief in one of the divine religions raised
Exclusion criteria:
Crisis incident after the start of the study for the patient
Hospitalization of the patient in the hospital due to relapse of the disease
Chronic illness that reduces the patient's function
Patient's death during the study stages
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on odd and even days
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
Faculty of Nursing and Midwifery, Faculty of Rehabilitation, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
Approval date
2018-08-31, 1397/06/09
Ethics committee reference number
IR.TUMS.FNM.REC.1397.092
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
N17-N19
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
Hope
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Schnayder adolescent Inventory with a likert spectrum
2
Description
Self-efficasy
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Self-efficacy questionnaire with Likert spectrum
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
2
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: the intervention group was treated individually 2 times per week, with 9 sessions of 45 minutes each patient at the bedside of her privacy. One month after the sessions, the participants were appreciated. Spirituality therapy sessions include: identifying and grounding spiritual experience, internalizing and describing, sources of fear and anxiety and our resources against them, infiniteness and inheritance, inheritance on the orbit and inheritance of Kane's circuit, meditation and calculation , Forgiveness and resolution of anger, selflessness, and reciprocity of the sessions of self-determination and the announcement of completion of the course
Category
Prevention
2
Description
Control group: after selecting the intervention and control groups and doing the pretest, from both groups, the control group underwent their normal treatment, one month after the initial referral, again, hope and autoimmunity were checked in the control group using the questionnaire.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Masoumeh Zamani
Street address
Imam Reza Street
City
Amol
Province
Mazandaran
Postal code
4614937597
Phone
Fax
Email
Imamreza@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ziba Taghizadeh
Street address
Tehran University of Medical Sciences, Tehran, Keshavarz Blvd., Ghodss St. Corner, Tehran University of Medical Sciences, Faculty of Nursing
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
Fax
Email
tums_edu@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Noghani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square - Nusrat Street East - Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 912 134 9575
Email
noghanif@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Noghani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
Phone
+98 912 134 9575
Email
noghanif@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Peiman Fereidouni
Position
Master student of psychiatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Vesal Street
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 918 774 2250
Email
Peimanfereidouni@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
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