Investigating The effectiveness of telenursing training on the suicidal Probability and thoughts of patients and the suicide literacy of caregivers of patients with depression admitted to Psychiatric Hospital
Determining the effect of telenursing training on the likelihood of suicide and suicidal thoughts of patients with depression and the suicide literacy of caregivers of patients with depression admitted to Ibn Sina Psychiatric Hospital in Mashhad.
Design
A randomized controlled clinical trial with a control group, parallel groups, double-blind, random allocation by block method, phase 2 on 140 people.
Settings and conduct
Place of the intervention in the health education nursing clinic of Ibn Sina Hospital, double blinding of participants and analysts
Participants/Inclusion and exclusion criteria
The final diagnosis of the patient at the time of discharge from the hospital is "depression".
The degree of depression is "moderate" or "severe".
The patient has a history of suicide attempts or thoughts in the past.
The patient does not have a history of chronic disease (chronic physical pain, cancer, incurable disease).
Intervention groups
Before the start of the intervention, patients and their main caregivers in both the intervention and control groups will be assigned to a one-hour face-to-face group training session. In the intervention group, in addition to face-to-face training, remote follow-up training (tele-nursing) by the researcher for 8 weeks after discharge from the hospital in the form of two phone calls per week for the first 4 weeks and one phone call per week for the second 4 weeks. It will be done for the patient and the main caregiver. No intervention will be done for the control group. Before and immediately one week after the end of the intervention, both the intervention and control groups will complete the Cal and Gil suicide probability questionnaire, the Beck suicidal ideation questionnaire and the suicide literacy questionnaire.
Main outcome variables
Patient's suicide possibility and thoughts, patient's caregiver's suicide literacy
General information
Reason for update
Acronym
تاه نرسینگ
IRCT registration information
IRCT registration number:IRCT20240602061991N1
Registration date:2024-06-14, 1403/03/25
Registration timing:prospective
Last update:2024-06-14, 1403/03/25
Update count:0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Shohre Behrouz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3605 7994
Email address
shohrebehrooz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The effectiveness of telenursing training on the suicidal Probability and thoughts of patients and the suicide literacy of caregivers of patients with depression admitted to Psychiatric Hospital
Public title
Investigating The effectiveness of telenursing training on the suicidal Probability and thoughts of patients and the suicide literacy of caregivers of patients with depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The final diagnosis of the patient at the time of discharge from the hospital is "depression".
The degree of depression is "moderate" or "severe".
The patient has a history of suicide attempts or thoughts in the past.
The patient does not have a history of chronic disease (chronic physical pain, cancer, incurable disease).
The patient and caregiver should not have drug addiction and drug use
The patient and caregiver have access to a landline or mobile phone
The patient and caregiver should have at least reading and writing literacy
The patient and caregiver are willing to participate in the study.
Exclusion criteria:
The patient or caregiver refuses to continue participating in the study and cooperating with the researcher
Failure to answer the phone by the patient or caregiver more than twice
The patient or caregiver has sudden accidents such as death or running away from home
Occurrence of physical disorders or mental disorders during the study that prevent the patient or caregiver from participating in the sessions.
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation random block method is used for random allocation. In this method, 9 blocks of 4 will be randomly selected from the combination of letters A and B. These blocks are AABB, ABBA, BBAA, BAAB, ABAB, BABA. We will also have a block of 2 in the form of AB or BA. The selection of blocks will be based on the table of random numbers and the preparation of blocks by someone outside the research team. The prepared blocks will be written on separate sheets and placed in sealed envelopes and will be provided to the researcher at the time of sampling. Allocation of letters A and B to the intervention and control groups will also be done randomly before the randomization by someone outside the research team so that being aware of the randomization process does not distort the selection.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in the intervention or control group were not told about how to implement the intervention.
The person in charge of data analysis was also blinded by coding the information in the software and not introducing the codes to him.
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
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.MUMS.REC.1403.071
Health conditions studied
1
Description of health condition studied
Suicidal thoughts, possibility of suicide, suicide health literacy in depressed patients
ICD-10 code
R45.851
ICD-10 code description
Suicidal ideations
Primary outcomes
1
Description
Suicidal thoughts in the Beck questionnaire
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention
Method of measurement
Beck suicidal ideation questionnaire (BSSI)
2
Description
suicide probability
Timepoint
before the start of the intervention and 8 weeks after the start of the intervention
Method of measurement
Cull and Gil suicide probability questionnaire
3
Description
Suicide literacy
Timepoint
before the start of the intervention and 8 weeks after the start of the intervention
Method of measurement
LOSS suicide literacy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to face-to-face training, remote follow-up training (tele-nursing) by the researcher for 8 weeks after discharge from the hospital in the form of two phone calls per week for the first 4 weeks and one phone call per week for the second 4 weeks. The patient and his main caregiver will be done from the direct line of the health education nursing clinic unit of Ibn Sina Hospital. The telephone call time will be between 9 am and 6 pm, according to the agreement with the patients' families, for 10 to 20 minutes. The content of educational conversations for 12 telenursing training sessions was prepared by reviewing the texts of other articles and the patient and family education protocol at the time of hospital discharge and was approved by 5 members of the hospital's academic staff.
Category
Other
2
Description
Control group: Before the start of the intervention, the patients and their main caregivers will be placed in both groups under a one-hour face-to-face group training session in the form of questions and answers based on the educational needs of the patients and their families, by the researcher, and at the end of the pamphlet Training will be given to them at the time of discharge. The purpose of holding this meeting will be to harmonize the theoretical knowledge of research samples at the time of starting the study. Then, the intervention group will be trained by telenursing method for 8 weeks, during which no intervention will be done for the control group. At the end of the intervention, in order to maintain ethics, all trainings will be provided to the patients of the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital
Full name of responsible person
alireza ebrahimi
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 313 9324
Email
ebrahimiar@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
محسن تفقدی
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 552 7723
Email
ebrahimiar@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
mashhad university medical science
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
علیرضا ابراهیمی
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 313 9324
Email
ebrahimiar@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
alireza ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
City of Knowledge and Health - Mashhad - at the end of Shahid Fakuri Blvd (in front of 94 Fakuri) - Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 313 9324
Email
ebrahimiar@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
alireza ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 313 9324
Email
ebrahimiar@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of telenursing on the suicidal thoughts and possibility of patients will be published
When the data will become available and for how long
At the end of 1403, the data can be analyzed and published
To whom data/document is available
All people have the ability to access information dissemination
Under which criteria data/document could be used
It is useful for most families of patients with depression
From where data/document is obtainable
Refer to the Google Scholar site
What processes are involved for a request to access data/document