Protocol summary

Study aim
1- Determining the effect of written emotional disclosure on the level of loneliness in the elderly 2- Determining the effect of written emotional disclosure on the level of death anxiety in the elderly
Design
In this study, the permutation block method will be used to generate the sequence of random allocation of individuals to the study groups. The sequence of random allocation of individuals will be performed using Random Allocation Software and a random block size. The permutation block method is one of the random allocation methods in which each block is selected as large as the number of study groups.
Settings and conduct
The present study is designed using a clinical trial method. One of the comprehensive health service centers covered by Mashhad Health Center No. 1 that has a sufficient number of covered elderly people with active health care records will be selected as the sampling environment. .
Participants/Inclusion and exclusion criteria
Age over 65 Not participating in an educational program at the same time Being literate, Not having communication problems such as speech impairment or
Intervention groups
Intervention group:. This group will participate in written emotional disclosure sessions once a week for 4 weeks. The sessions include writing about the elderly person's deepest feelings and negative and positive experiences related to aging and psychological changes during aging. Control group: In the control group, the center's routine activities will be carried out, including educational classes for the elderly held in groups and integrated care for the elderly, which includes examining the general health status of the elderly.
Main outcome variables
Loneliness: To measure loneliness, the Loneliness Questionnaire by Wongpakaran et al. will be used. Death Anxiety: . The Death Anxiety Scale was developed to measure death anxiety.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251214068331N1
Registration date: 2025-12-28, 1404/10/07
Registration timing: prospective

Last update: 2025-12-28, 1404/10/07
Update count: 0
Registration date
2025-12-28, 1404/10/07
Registrant information
Name
Mohammad Amidpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3389 6240
Email address
mohammad.amidpoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-10, 1404/10/20
Expected recruitment end date
2026-02-09, 1404/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of written emotional disclosure on the level of loneliness and death anxiety of elderly
Public title
Investigating the effect of written emotional disclosure on the level of loneliness and death anxiety of elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not having any serious physical illnesses Not having a diagnosed mental disorder Being able to read and write,
Exclusion criteria:
Lack of literacy
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the permutation block method will be used to generate the sequence of random allocation of individuals to the study groups. The sequence of random allocation of individuals will be performed using Random Allocation Software and a random block size. The permutation block method is one of the random allocation methods in which each block is selected as large as the number of study groups.
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 Mashhad University of Medical Sciences
Street address
Seydi Street - Sobhan Street - Sobhan 29 - No. 12 - Unit 3
City
mashhad
Province
Razavi Khorasan
Postal code
9163797413
Approval date
2025-12-06, 1404/09/15
Ethics committee reference number
IR.MUMS.REC.1404.288

Health conditions studied

1

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

Primary outcomes

1

Description
Loneliness: The loneliness questionnaire by Wongpakaran et al. will be used to measure loneliness. This tool has been validated and approved in Iran. It is expected that the intervention will reduce loneliness in the elderly and the resulting anxiety.
Timepoint
The post-test will be administered by the researcher one week later and one month after the end of the fourth session.
Method of measurement
Loneliness: The loneliness questionnaire by Wongpakaran et al. will be used to measure loneliness. This tool has been validated and approved in Iran. It is expected that the intervention will reduce loneliness in the elderly and the resulting anxiety.

2

Description
.Death anxiety: Death anxiety is often referred to as the fear of dying yourself and others or the anxiety caused by thinking about the dying process or its consequences. To measure death anxiety, the death anxiety scale created by Templer in 1970 will be used, which has been validated and approved in Iran.
Timepoint
The post-test will be administered by the researcher one week later and one month after the end of the fourth session.
Method of measurement
Death anxiety: Death anxiety is often referred to as the fear of dying yourself and others or the anxiety caused by thinking about the dying process or its consequences. To measure death anxiety, the death anxiety scale created by Templer in 1970 will be used, which has been validated and approved in Iran.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Intervention group: This study includes elderly people referring to one of the comprehensive health service centers under the coverage of Health Center No. 1 in Mashhad who will be randomly selected to receive the written emotional disclosure intervention. This group will participate in written emotional disclosure sessions once a week for 4 weeks. The sessions include writing about the elderly person's deepest feelings and negative and positive experiences related to aging and psychological changes during aging.
Category
Other

2

Description
Control group: Control group: In the control group, the center's routine activities will be carried out, including educational classes for the elderly held in groups and integrated care for the elderly, which includes examining the general health status of the elderly.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Amidpoor
Street address
Health Centers No. 1
City
Mashhad
Province
Razavi Khorasan
Postal code
1111111111
Phone
+98 51 3841 2081
Email
mohammad.amidpoor@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Razavi Khorasan, Mashhad, Daneshgah Street, next to Hoveyzeh Cinema, University of Medical Sciences, Third Floor, Vice-Chancellor for Research and Technology of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
1111111111
Phone
+98 51 3841 1538
Email
TafaghodiM@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
Mohammad Amidpoor
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Seydi, No. 12, Unit 3, 29, Sobhan Street, Sobhan
City
Mashhad
Province
Razavi Khorasan
Postal code
11111111111
Phone
+98 51 3389 6240
Email
mohammad.amidpoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Amidpoor
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Seydi, No. 12, Unit 3, 29, Sobhan Street, Sobhan
City
Mashhad
Province
Razavi Khorasan
Postal code
1111111111
Phone
+98 51 3389 6240
Email
mohammadamidpoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Amidpoor
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Seydi, No. 12, Unit 3, 29, Sobhan Street, Sobhan
City
Mashhad
Province
Razavi Khorasan
Postal code
1111111111
Phone
+98 51 3389 6240
Email
mohammadamidpoor@yahoo.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
No further information available.
Study Protocol
No - There is not 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
No - There is not 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
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