Investigating the Effectiveness of Spiritual Care on acceptance of illness, the quality of nurse-patient communication, and the level of anxiety and depression in patients admitted to the internal ward
Determining the effectiveness of spiritual care on disease acceptance, quality of nurse-patient communication and level of anxiety and depression in patients admitted to the internal ward of Hazrat Rasool Akram hospital
Design
The present study is a clinical trial with pre-test-post-test and its statistical population includes all patients admitted to the internal department of Hazrat Rasool Akram and Firouzgar hospitals. The samples of this research will be selected purposefully from the patients who want to receive spiritual care. Forty people will be assigned to the intervention group and 40 people will be assigned to the control group.
Settings and conduct
The location of the clinical trial of the present study is the internal ward of Hazrat Rasool Akram and Firouzgar hospitals in Tehran. The study population is the patients of the internal ward of the two mentioned hospitals. Blinding will not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to receive spiritual care and participate in research; being hospitalized in the internal ward of the hospital at the time of conducting the research; Being Iranian and Persian speaker.
Exclusion criteria: Discharged from the hospital; Outpatients; Having history of psychological problems, blindness and deafness
Intervention groups
Intervention group: internal ward of Hazrat Rasool Akram Hospital،Control group: internal ward of Firouzgar Hospital
Spiritual care intervention is provided to the intervention group based on the clinical guidelines provided in the study of Bowalhari and Memarian.
Main outcome variables
Acceptance of the disease; the quality of nurse-patient relationship; Level of anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190518043626N2
Registration date:2024-04-05, 1403/01/17
Registration timing:prospective
Last update:2024-04-05, 1403/01/17
Update count:0
Registration date
2024-04-05, 1403/01/17
Registrant information
Name
Fatemeh Rezaei Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3353 3400
Email address
fatma.rezaei72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2024-06-14, 1403/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Spiritual Care on acceptance of illness, the quality of nurse-patient communication, and the level of anxiety and depression in patients admitted to the internal ward
Public title
Investigating the effect of spiritual care on hospitalized patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to receive spiritual care and participate in research
Being hospitalized in the internal ward of the hospital at the time of conducting the research
Being Iranian and speaking in Persian
Exclusion criteria:
Discharged from the hospital
Outpatients
having a history of psychological problems, blindness, deafness
Companions of patients hospitalized in the internal ward who stay by their side continuously to do the patient’s work.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences; Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.IUMS.REC.1402.1034
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
Primary outcomes
1
Description
acceptance of illness
Timepoint
Before starting the intervention, after the intervention
Method of measurement
Acceptance of illness questionnaire
2
Description
quality of nurse-patient communication
Timepoint
Before starting the intervention, after the intervention
Method of measurement
nurse-patient comm questionnaire
3
Description
Level of anxiety and depression
Timepoint
Before starting the intervention, after the intervention
Method of measurement
hospital anxiety and depression scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The internal ward of Hazrat Rasool Akram Hospital will be considered as the intervention group of the present study.The patients of the internal ward of this hospital will fill out the hospital anxiety and depression scale (HADS), illness acceptance questionnaire and nurse-patient Communication questionnaire as a pre-test before providing spiritual care.Then, in the internal ward of Hazrat Rasool Akram hospital, two senior psychology experts who are trained in the field of spiritual care and have relevant work experience will visit the patients in the afternoon and will receive a semi-structured interview based on their spiritual history and will be recorded in the reporting form, and if there is a need to answer the patient's spiritual questions, they will take it upon themselves.If they need deeper spiritual care, they will be referred to a clinical chaplain who has level two seminary expertise and work experience and training in the field of spiritual care. The clinical chaplain will visit the referred patients in the afternoon and provide them with spiritual care and record them in the reporting form.Finally, after the completion of providing spiritual care to the sample considered in this research, the mentioned questionnaires will be filled again by the patients as a post-test. Spiritual care will be provided based on the clinical guidelines provided in the study of Bowalhari and Memaryan regarding the provision of spiritual services for cancer patients.
Category
Rehabilitation
2
Description
Control group: Patients hospitalized in the internal ward of Firuzgar Hospital will only fill the mentioned questionnaires in the form of pre-test and post-test, but will not receive spiritual care, and finally, the researchers of this research will implement ethical considerations at the end of the research and will offer this spiritual care intervention to the patients if they desire.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Internal ward of Hazrat Rasool Akram Hospital affiliated to Iran University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei Khodadadi
Street address
Hazrat Rasool Akram hospital; Niyayesh street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 913 051 4827
Email
Fatma.rezaei72@gmail.com
2
Recruitment center
Name of recruitment center
Internal ward of Firuzgar Hospital affiliated to Iran University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei Khodadadi
Street address
Firuzgar hospital; Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 913 051 4827
Email
Fatma.rezaei72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza falak
Street address
Iran University of Medical Sciences; Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh rezaei khodadadi
Position
Research expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences; Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 913 051 4827
Email
Fatma.rezaei72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei Khodadadi
Position
Research expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences; Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 913 051 4827
Email
Fatma.rezaei72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh rezaei khodadadi
Position
Research expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences; Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 913 051 4827
Email
Fatma.rezaei72@gmail.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
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After conducting our research, if desired, we can share the data obtained from the participants, the protocol and the results.
When the data will become available and for how long
The data will be made available to interested researchers 12 months after the completion of the project. The period of time when the data is available to each researcher is three days.
To whom data/document is available
For researchers who want to see the data
Under which criteria data/document could be used
It will be made available to the main researcher of the project if he/she wishes
From where data/document is obtainable
From the email of the main researcher of the project
What processes are involved for a request to access data/document
After sending the email to the main researcher, she provides the data to the requester with permission from other colleagues.