This study aims to investigate the effect of culture-based intervention in the care of nurses on improving their mental health.
Design
The present study will be an open trial study. The current study is quasi-experimental with a two-group pre-test and post-test design. This is a single-blinded trial with a parallel-group design. The sample size was calculated based on a previous study. The sample size was determined by considering 20% dropouts 48 people in each group and a total of 96 people.
Settings and conduct
First, interested nurses will be invited by announcement in two hospitals. After obtaining informed consent, the pre-test will be performed. After 5 sessions of LBRT (two sessions a week), the post-test will be taken from them immediately. The control group doesn't receive any intervention.
Considering that the effectiveness of LBRT intervention on nurses' anxiety and depression has been confirmed in a previous study, in the present study, the effectiveness of this protocol on nurses' anxiety and depression is to be tested in a larger sample size and a more realistic and less laboratory environment in the form of an open trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: nurse samples from hospitals
Exclusion criteria: 1- Those who have severe psychological disorders and suicidal thoughts
2- Those who have recently received psychological interventions
3- Those who are absent for more than one meeting
Intervention groups
We have two intervention groups: 1- Logotherapy Based on Rumi's Thoughts consists of 8 sessions: Sense of source, Self-control in the path of change, Acceptance, Assimilation of suffering and making meaning, Dhikr and meditation (mindfulness), Death anxiety and making meaning, Patience in suffering, and Gratitude. 2- Control group: The control group doesn't receive any intervention
Main outcome variables
anxiety, depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091220002898N15
Registration date:2024-04-09, 1403/01/21
Registration timing:registered_while_recruiting
Last update:2024-04-09, 1403/01/21
Update count:0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Seyed Hamzeh Hosseini
Name of organization / entity
Mazandarn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 3886
Email address
shhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-04, 1403/01/16
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Logotherapy Based on Rumi’s Thoughts on Symptoms of Anxiety and Depression in Nurses
Public title
Effect of Logotherapy Based on Rumi’s Thoughts on Symptoms of Anxiety and Depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
nurse samples from hospitals
Exclusion criteria:
Those who have severe psychological disorders and suicidal thoughts
Those who have recently received psychological interventions
Those who are absent for more than one meeting
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person analyzing the data is outside the treatment group and doesn't know the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran university of medical sciences
Street address
Moalem square
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2024-03-18, 1402/12/28
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.20350
Health conditions studied
1
Description of health condition studied
Anxiety, Depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
2
Description
Depression
Timepoint
Before and after the intervention
Method of measurement
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: LBRT included: Sense of source, Self-control in the path of change, Acceptance, Assimilation of suffering and making meaning, Dhikr and meditation (mindfulness), Death anxiety and making meaning, Patience and tolerance in suffering, Gratitude. It was presented in five sessions of 90 minutes.
Category
Treatment - Other
2
Description
Control group: They will not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hospital
Full name of responsible person
Hamzeh Hosseini
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
4816979436
Phone
+98 11 3335 0670
Email
hosseinish20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad ALI Enayati
Street address
Deputy of research and technology of Mazandaran university of medical sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Hamzeh Hosseini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Imam square
City
Sari
Province
Mazandaran
Postal code
4816979436
Phone
+98 11 3336 9323
Email
shhosseini@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Hamzeh Hosseini
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Sari
City
Sari
Province
Mazandaran
Postal code
4816979436
Phone
+98 15 1328 3886
Email
shhosseini@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Hamzeh Hosseini
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Sari
City
Sari
Province
Mazandaran
Postal code
4816979436
Phone
+98 15 1328 3886
Email
shhosseini@mazums.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
all researchers
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document