Effect of spiritual care on the Quality of Sleep and spiritual health of the Elderly in Isfahan
Design
This interventional study will be conducted on 60 people (30 intervention people and 30 control people), among the elderly referring to health centers in Isfahan, using the available sampling method. Considering the sample size in the present study (less than 100) and to prevent the problem of imbalance between the groups, the studied sample will be allocated to two intervention and control groups using the Block Randomization method.
Settings and conduct
The target community will be the elderly living in Isfahan city. Sampling will be done as available and among the elderly who refer to health centers in Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Age over 60 years
2. Under the cover of the health center and constantly visiting that health center
3. Physical and mental ability to communicate (to complete the questionnaire)
4. Be able to speak and understand Persian language.
Exclusion criteria
1. Unwillingness to continue participating in research
2. Lack of cooperation and satisfaction during the training sessions and not completing the assignments presented in the sessions
Intervention groups
In this study, two measures of active listening and instilling hope will be performed in the form of spiritual care group sessions during 6 weekly sessions of 45 to 60 minutes(39) for the intervention group in the health center.
* In order to comply with ethical considerations, the items taught in the training sessions will be given to the control group in the form of a pamphlet as a training package after completing the second stage of the questionnaires.
Main outcome variables
sleep quality, spiritual care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200119046186N2
Registration date:2023-09-02, 1402/06/11
Registration timing:retrospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Majid Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 9821
Email address
rahimi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Impact of spiritual care on sleep quality and spiritual health of elderly
Public title
Evaluation Impact of spiritual care on sleep quality and spiritual health of elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Having the ability to orient in relation to place and time
. Under the cover of the health center and constantly visiting that health center
Physical and mental ability to communicate (to complete the questionnaire)
Willingness to participate in the research at the time of the research should not be simultaneously investigated in other experimental researches.
Be able to speak and understand Persian language.
Exclusion criteria:
Unwillingness to continue participating in research
Simultaneous use of prescribed psychiatric drugs during intervention
Lack of cooperation and satisfaction during the training sessions and failure to complete the assignments presented in the sessions
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the sample size in the present study (less than 100) and in order to prevent the problem of imbalance between the groups, the studied sample will be allocated to two intervention and control groups using the Block Randomization method. For this purpose, at first, all possible combinations of 4 of the two studied groups (A, B) will be considered in the following order.
AABB, BBAA, ABAB, BABA, ABBA, BAAB
Each of the above 4 blocks will include 2A and 2B. From 1 to 6, a number will be assigned to each of the mentioned blocks. Then, in the table of random numbers, one-digit numbers will be selected randomly (from top to bottom or vice versa, or from left to right or vice versa). Each of the numbers 1 to 6 that appeared in the random number table is the same block.
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 Isfahan University of Medical Sciences
Street address
Hezar_jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.MUI.RESEARCH.REC.1402.084
Health conditions studied
1
Description of health condition studied
Spiritual health in normal older people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Spiritual Health
Timepoint
Before and immediately and three months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Sleep Quality
Timepoint
Before and immediately and three months after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: In this study, to perform spiritual care, two criteria of active listening and instilling hope will be done through spiritual care group sessions during 6 weekly sessions of 45 to 60 minutes in a group at the health center.
Category
Lifestyle
2
Description
Group: The items taught in educational control sessions in the form of pamphlets in the form of an educational package will be available to the control group after completing the second stage of the questionnaire.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center number one in Isfahan
Full name of responsible person
Dr.Hamid Galedari
Street address
Ebne sina
City
Isfahan
Province
Isfehan
Postal code
81486-53374
Phone
+98 31 3448 5558
Email
moradi136013@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahin Shirani
Street address
Hezar_jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
majidnh79@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Majid Rahimi
Position
Asisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
First Floor, No. 47 Hajian Alley Simin Street
City
Isfahan
Province
Isfehan
Postal code
8176935747
Phone
+98 31 3776 9821
Email
majidnh79@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Majid Rahimi
Position
Asisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
First Floor, No. 47 Hajian Alley Simin Street
City
Isfahan
Province
Isfehan
Postal code
8176935747
Phone
+98 31 3776 9821
Email
majidnh79@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Rahimi
Position
Asisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
First Floor, No. 47, Hajian Alley, Simin Street
City
Isfahan
Province
Isfehan
Postal code
8176935747
Phone
+98 31 3776 9821
Email
majidnh79@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