Determining the effectiveness of spiritual intervention on pain intensity and quality of life in end-of-life patients
Design
The statistical sample size is 60 people (30 people in the intervention group and 30 people in the control group). In the present study, the 26-item World Health Organization Quality of Life Questionnaire and the Won Korf Pain Intensity Questionnaire will be used.
Settings and conduct
The study site is Imam Reza Hospital in Mashhad and the sampling method is simple non-random that the target population is patients in the end stage of cancer life of Imam Reza Hospital in Mashhad.
Participants/Inclusion and exclusion criteria
ents at the end of cancer life stage, consent to participate in the study, age 16 years and older, minimum primary education, Shiite religion, level of consciousness above 8
Intervention groups
The intervention group consists of patients who provide spiritual care content based on the titles of the Richards & Bergin protocol sessions over six 60-minute sessions over four months.
The control group is patients who receive only routine interventions performed on patients so far and do not receive any spiritual intervention.
Main outcome variables
Reducing pain and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210513051282N1
Registration date:2021-07-11, 1400/04/20
Registration timing:registered_while_recruiting
Last update:2021-07-11, 1400/04/20
Update count:0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
seyed mahmoud tabatabaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 5777
Email address
tabanet@um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of spiritual intervention on pain intensity and quality of life in end-of-life patients
Public title
Evaluation of the effectiveness of spiritual intervention on pain intensity and quality of life in end-of-life patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
According to medical parameters, they are less than 6 months old
Has at least a diploma
Age 19 years and above
Believes in the Shia religion
Awareness above 8
Exclusion criteria:
Decrease the patient's level of consciousness to less than 8 during interventions for 4 consecutive days
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad, Azadi Square, Campus, University, School of Medicine, Department of Medical Ethics
City
mashhad
Province
Razavi Khorasan
Postal code
9194568899
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
1396.814
Health conditions studied
1
Description of health condition studied
Reducing pain and quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduce pain
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Von Korf Pain Intensity Questionnaire
2
Description
Quality of Life
Timepoint
Von Korf Pain Intensity Questionnaire
Method of measurement
Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Spiritual Care Content is based on the titles of Richards and Bergin Spiritual Intervention Sessions in six 60-minute sessions over four months.
Category
Rehabilitation
2
Description
Control group: The control group is patients who receive only routine interventions performed on patients so far and do not receive any spiritual intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ehsan Izadipour
Street address
Ibn Sina St. Imam Reza Hospital Square Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9178787665
Phone
+98 51 3841 5777
Email
Izadipoure2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Tafqadi
Street address
University Street in front of the University 18 Central Building of Mashhad University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
917876655
Phone
+98 51 3841 5777
Email
Izadipoure2@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mahmoud Tabatabaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Ethics
Street address
University Street in front of the University 18 Central Building of Mashhad University of Medical Sciences Office of the Leadership Institution
City
mashhad
Province
Razavi Khorasan
Postal code
917786655
Phone
+98 51 3841 5777
Email
tabanet@um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan Izadipour
Position
expert
Latest degree
Bachelor
Other areas of specialty/work
Medical Ethics
Street address
University Street in front of the University 18 Central Building of Mashhad University of Medical Sciences Office of the Leadership Institution
City
mashhad
Province
Razavi Khorasan
Postal code
917876655
Phone
+98 51 3841 5777
Email
Izadipoure2@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fatemeh rezaei
Position
Researcher psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
University Street in front of the University 18 Central Building of Mashhad University of Medical Sciences Office of the Leadership Institution
City
mashhad
Province
Razavi Khorasan
Postal code
917876655
Phone
+98 51 3841 5777
Email
rezaeif7@mums.ac.ir
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