Protocol summary

Study aim
Comparison of the effect of spiritual therapy and education based on Orem self-care model on lifestyle, anxiety, depression and chronic pain in retired elderly of armed forces
Design
In this quasi-experimental study, the samples will be randomly divided into two groups of education based on Orem self-care model and spiritual therapy intervention.
Settings and conduct
The present study will be conducted on elderly people referring to the retirement centers of the Armed Forces of Masjed Soleyman. After obtaining the required code of ethics and permits, the researcher begins sampling according to the inclusion criteria. After the researchers have fully justified the samples, the participants complete the questionnaires. Then the samples will be randomly divided into two intervention groups (Orem self-care model) and second intervention group (Spirituality therapy).
Participants/Inclusion and exclusion criteria
Entry Criteria: Elderly retired armed forces aged 60 years and over Having reading and writing skills Consent to participate in the study Non entry Criteria: Any disorder that impedes the intervention or affects the results of the study
Intervention groups
In the first intervention group, education will be based on Orem self-care model and in the second intervention group spiritual therapy will be performed.
Main outcome variables
Lifestyle, anxiety, depression and chronic pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170117032023N3
Registration date: 2019-12-23, 1398/10/02
Registration timing: registered_while_recruiting

Last update: 2019-12-23, 1398/10/02
Update count: 0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4323 0999
Email address
madmoli.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of spiritual therapy and education based on Orem self-care model on lifestyle, anxiety, depression and chronic pain in retired elderly of armed forces
Public title
Effect of spiritual therapy and education based on Orem self-care model on lifestyle, anxiety, depression and chronic pain in retired elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly retired armed forces aged 60 years and over Having reading and writing skills Consent to participate in the study
Exclusion criteria:
Any disorder that impedes the intervention or affects the results of the study
Age
From 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly divided into two intervention groups (Orem self-care model) and second intervention group (Spirituality therapy).
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 Baqiyatallah University of Medical Sciences
Street address
Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.BMSU.REC.1398.205

Health conditions studied

1

Description of health condition studied
Elderly
ICD-10 code
O09.52
ICD-10 code description
Supervision of elderly multigravida

Primary outcomes

1

Description
Lifestyle
Timepoint
Lifestyle measurement at baseline (before intervention) and 3 months after intervention
Method of measurement
Lifestyle Questionnaire

2

Description
Anxiety
Timepoint
Anxiety measurement at baseline (before intervention) and 3 months after intervention
Method of measurement
Anxiety questionnaire

3

Description
Depression
Timepoint
Depression measurement at baseline (before intervention) and 3 months after intervention
Method of measurement
Depression questionnaire

4

Description
Chronic pain
Timepoint
Chronic pain measurement at baseline (before intervention) and 3 months after intervention
Method of measurement
Chronic pain questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: The Orem-based self-care education will be done based on the self-care ability and educational needs of the elderly.This intervention will be 4 sessions a week in between (2 months total).
Category
Lifestyle

2

Description
Second intervention group: Richards and Bergin's spiritual therapy will be done.This intervention will be taught in 14 stages over 4 training sessions by a religious expert for two months.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Residents of the Khuzestan Islamic Revolutionary Guard Corps
Full name of responsible person
Khodadad Bagheri
Street address
West Mordad Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6311973484
Phone
+98 61 3376 5021
Email
khozestan.sadeghan@info.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Jalali Farahani
Street address
Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
a-Jalalifarahani@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Morteza Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8806 8923
Email
sm_hosseini@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Morteza Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8806 8923
Email
sm_hosseini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yaghoob Madmoli
Position
Clinical instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Martyr Nozar Khodadadi alley, No.8
City
Masjed Soleyman
Province
Khouzestan
Postal code
6491853954
Phone
+98 61 4323 0999
Email
ymadmoli@gmail.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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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