Increasing spiritual health, reducing stress and anxiety in hemodialysis patients
Design
The present study is a clinical trial study, before and after intervention. The aim of this study was to determine the effect of autonomous spiritual counseling based on the heart-healthy model on the dependent variable of spiritual well-being, depression and anxiety in hemodialysis patients.
Settings and conduct
The demographic data of patients will be studied and then they will be selected on the basis of inclusion criteria. Then, the patients will be informed of the method of study (Sound of heart model) in details. Then, written informed consent is taken from them. They are asked to fill 3 questionnaires, (Spiritual health, depression and anxiety).Patients will be divided into experimental and control groups by random allocation.Two groups are not interconnected together. After intervention, all three questionnaires must be filled again and compared to control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-adult patients (18 years or older)
2. The minimum reading and writing literacy
3- Being able to communicate to complete the questionnaire
4. No history of chronic mental illness in the past and now
5. Not to use psychosocial drugs, Farsi language, have at least one year of dialysis, dialysis at least twice a week.
6. Not having a history of attending spiritual meetings or spiritual training sessions simultaneously.
Exclusion criteria:
1) Another other life-threatening diseases
2) No desire to continue the research on the patient's side
Intervention groups
The intervention group of hemodialysis patients who receive spiritual counseling.The control group of hemodialysis patients do not receive spiritual counseling.
Main outcome variables
Quality of Life
mental health
Spiritual care based on Selim's Heart Consultation Model
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181103041532N1
Registration date:2018-12-20, 1397/09/29
Registration timing:registered_while_recruiting
Last update:2018-12-20, 1397/09/29
Update count:0
Registration date
2018-12-20, 1397/09/29
Registrant information
Name
Zahra Nasrollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3320 9074
Email address
znasrollahi2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spiritual Counseling based on Sound Heart Model on the Spiritual Well-being, Depression and Anxiety in Dialysis patients.
Public title
Effect of spiritual counseling on spiritual well-being, depression and anxiety in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (over 18 years old)
At least the reading and writing skills
Being able to communicate to complete the questionnaire
Not having a history of chronic mental illness in the past and now
Not to use psychosocial drugs, Farsi language, have at least one year of dialysis, dialysis at least twice a week.
Not having a history of attending spiritual meetings or spiritual health training courses simultaneously
Exclusion criteria:
A severe physical or psychological crisis in addition to kidney failure
Cause of other life-threatening diseases
Unwillingness to continue research on the part of the patient
Transmission for hemodialysis to the other center by the patient
Candidate for renal transplantation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are divided into two groups.
A control group that takes only Dialysis treatment.
The other group is Dialysis treatment plus spiritual counseling.
Both groups, the control group and the test group, should remain unaware of the other group, as the information shouldn't exchange between two groups.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences opposite of yadegar-e- Imam Ghadir BLV Qom Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
۱۳۹۷/۶/۲۰طرح پژوهشی بررسی تاثیر مشاوره معنوی مبتنی بر مدل قلب سلیم برسلامت معنوی، افسردگی واضطراب بیماران همودیالیزی شهر قم IR.MUQ.REC.1397.083 ۸۳
Health conditions studied
1
Description of health condition studied
dialysis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
Primary outcomes
1
Description
Spiritual well-being.
Timepoint
After intervention (after 10 consultation sessions).
Method of measurement
Questionnaire of Spiritual well-being.
2
Description
Anxiety.
Timepoint
After intervention (after 10 consultation sessions)
Method of measurement
Questionnaire of Anxiety.
3
Description
Stress.
Timepoint
After intervention (after 10 consultation sessions)
Method of measurement
Questionnaire of Stress
Secondary outcomes
1
Description
Stress score
Timepoint
Once upon a spiritual intervention
Method of measurement
Spiritual Health Questionnaire, Stress Questionnaire, Anxiety Inventory
2
Description
Anxiety Score
Timepoint
After spiritual intervention
Method of measurement
Through the questionnaire
Intervention groups
1
Description
There are two groups. 1. A control group that receives only conventional Dialysis treatments. 2. An intervention group that also undergoes a spiritual intervention in addition to Dialysis treatments. The spiritual intervention in 10 sessions is as the following: First session: Familiarity; second session: People's feelings and attitudes to life stress; Third session: Attention to the positive aspects of the problem and the purpose of life; Fourth session: The concept of health and its dimensions, spiritual well-being and the characteristics of the healthy human being; the Fifth session: The effect of different dimensions of health on each other; the sixth session: Self-awareness of self-care needs; the Seventh session; The development of social communication; the Eighth session; Coping with spiritual care recipes; meeting ninth: Self-control; Teaching the skill of self-assessment daily; Session 10: Completing questionnaires and answering questions and Final assessing.
Category
Behavior
2
Description
Intervention group: Spiritual counseling is based on the ُSALIM heart model on the hemodialysis patient intervention group, while hemodialysis treatment is also performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
zahra nasrollahi
Street address
qom medical university opposite of yadegar-e- Imam Ghadir BLV Qom Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
znasrollahi2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. hossein saghafi
Street address
ghadir BLV Qom
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3285 4011
Email
dr.hosseinsaghafi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
zahra nasrollahi
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
ghadir BLV qom
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
znasrollahi2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
zahra nasrollahi
Position
assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
ghadir BLV Qom
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
znasrollahi2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
zahra nasrollahi
Position
assistant prof.
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
ghadir BLV Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
znasrollahi2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Not defined in the scheme. No need to feel
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