Protocol summary

Study aim
Determining the effect of spiritual care on the level of death anxiety of the elderly
Design
The type of study is a clinical trial with parallel groups. The studied groups include 33 elderly residents of Mader Sabzevar Nursing Home (as control group) and 33 elderly members of day care centers for the elderly in Shahranishabur (as intervention group) who are selected through simple random sampling.
Settings and conduct
The place of the study is Mehr Parandis Day Care Center for the Elderly (Farzangan Foundation), Nishaboro County, Sabzevaranjam County Nursing Home. Spiritual care based on the intervention method of Richards and Bergin with an Islamic and indigenous approach will be conducted by researchers in 8 sessions of 45 to 60 minutes for the elderly in the intervention group. There is no blinding condition.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 60 years؛ ability to communicate visually and verbally؛ ability to speak Persian؛ not simultaneously participating in research related to the research topic؛ experience of at least 6 months in the center؛ obtaining a score above 8 Templer Death Anxiety Questionnaire Criteria for not entering: not believing in Islam؛ suffering from mental disorders according to the medical record of the elderly؛experiencing a stressful event in the last three months (such as losing a spouse or other loved ones)
Intervention groups
Spiritual care based on the intervention method of Richards and Bergin with an Islamic and localized approach will be carried out during 8 sessions of 45 to 60 minutes for the elderly in the intervention group. The control group received usual care. Immediately after the completion of the intervention phase and one month after the intervention, the death anxiety questionnaire will be filled by the control and intervention groups
Main outcome variables
Elderly death anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231115060060N1
Registration date: 2023-12-05, 1402/09/14
Registration timing: prospective

Last update: 2023-12-05, 1402/09/14
Update count: 0
Registration date
2023-12-05, 1402/09/14
Registrant information
Name
Robabe Bozhmehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 4640
Email address
bozhmehraniro1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-23, 1402/10/02
Expected recruitment end date
2024-02-08, 1402/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of spiritual care on the level of death anxiety of the elderly
Public title
Evaluation the effect of spiritual care on the level of death anxiety of the elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and written consent to participate in the study Age over 60 years Ability to communicate visually and verbally Ability to speak Persian Experience of at least 6 months in the centers Obtaining a score above 8 on the Templar death anxiety questionnaire
Exclusion criteria:
Lack of belief in Islam Suffering from mental disorders according to the medical record of the elderly Experiencing a stressful event in the last three months (such as losing a spouse or other loved ones)
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
In the elderly of Mehr Parndis Center, 33 people who have death anxiety above 8 and meet the other inclusion criteria are selected as the intervention group by a simple random sampling method, and in the elderly of Mother Nursing Home, 33 people who have death anxiety above 8 and other inclusion criteria are selected as the intervention group. are selected as the control group through simple random sampling. If the number of samples is more than the desired number, the names of all the elderly are placed in similar envelopes and sealed, and 33 envelopes are randomly selected from among the envelopes, and if the number of samples is the same as the desired number of samples, a census is performed. In this study, there is no blinding condition.
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
Research Ethics Committee of Sabzevar University of Medical Sciences
Street address
No. 7, 14 Maalem Alley, Maalem Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318783593
Approval date
2023-11-14, 1402/08/23
Ethics committee reference number
IR.MEDSAB.REC.1402.077

Health conditions studied

1

Description of health condition studied
Elderly death anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Death anxiety score in Templer questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the end of the intervention, one month after the end of the intervention
Method of measurement
Templer Death Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this research, spiritual care based on the intervention method of Richards and Bergin with an Islamic and indigenous approach will be carried out during 8 sessions of 45 to 60 minutes for the elderly in the intervention group, by the researcher and with the cooperation and supervision of a senior expert in Quran and Hadith sciences. Before starting the intervention, the researcher will receive the necessary training from a senior expert in Quran and Hadith sciences. The contents of the sessions and their content are adjusted based on similar studies and the opinions of 3 expert professors in this field, which are as follows: First session: getting to know the participants and the therapist. The second session: explaining the meaning of spirituality and the meaning of life and suffering. The third session: Using some verses of the Qur'an in facing problems and gaining peace. The fourth session: Discussion about prayer with emphasis on the prayer of 50 books of Sajjadiyyah. The fifth session: Explaining the concept of patience and the effects of patience and expressing patterns based on religious personalities. The sixth session: The effect of gratitude and religious remembrances. Eighth session: Participation in spiritual and religious programs
Category
Lifestyle

2

Description
Control group: They do not receive any intervention and routine care is performed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Parandis Day care center for the elderly (Farzangan Foundation) in Neishabur city
Full name of responsible person
Alireza Talai
Street address
4 Shariati Alley, Shariati Street
City
Neyshabour
Province
Razavi Khorasan
Postal code
9313776147
Phone
+98 51 4334 6330
Email
nargsmarlwyy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hassanpour
Street address
Research and Technology Vice-Chancellor, University of Medical Sciences Campus, Above the Memorial of the Unknown Martyrs, Nuclear Martyrs Blvd.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Email
vc.Research@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice Chancellor of Education, University of Medical Sciences campus building, Tawheed Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
009851144018314
Email
Mostafarad633@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice Chancellor of Education, University of Medical Sciences campus building, Tawheed Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
009851144018314
Email
Mostafarad633@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice Chancellor of Education, University of Medical Sciences campus building, Tawheed Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
009851144018314
Email
Mostafarad633@yahoo.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
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
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