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Evaluation of the effectiveness of logotherapy based on Rumi’s thoughts on the anxiety, depression, and distress of frontline nurses during the COVID-19 epidemic

Protocol summary

Study aim
1- Evaluation of the effectiveness of logotherapy based on Rumi’s thoughts on the anxiety, depression, and distress of frontline nurses during the COVID-19 epidemic 2- Evaluation of the effectiveness of spirituality on psychological variables in frontline nurses during the COVID-19 epidemic
Design
A single-blinded, randomized, and controlled trial with a parallel-group design of 32 participants followed for 2 months
Settings and conduct
Initially, two hospitals that were a reference for medical referrals for Covid disease were selected. The available sampling method was used. Due to the fact that the study was conducted during the COVID-19 epidemic, after obtaining written permission from the participants, we sent them the link of the online questionnaire (pre-test) for them, and after filling in, the class link was sent to them. After 8 sessions of virtual intervention and post-test, participants were followed up after two months. The person analyzing the data was unaware of the participants' intervention.
Participants/Inclusion and exclusion criteria
inclusion criteria: Nurses who had been on the front lines during the Covid-19 pandemic were recruited exclusion criteria: Nurses with severe psychological disorders, suicidal thoughts, and those who had recently received the psychological intervention were excluded from the study.
Intervention groups
we had two intervention groups: 1- Logotherapy Based on Rumi's Thoughts consists of 8 sessions: perception of source, Self-control in the path of change, acceptance, Adjustment with suffering and meaning-making, Dhikr and meditation (mindfulness), Death anxiety and finding the meaning of love, Patience in suffering, and Gratitude. 2- Control group: The control group did not receive any intervention
Main outcome variables
anxiety, depression, distress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091220002898N13
Registration date: 2022-06-29, 1401/04/08
Registration timing: retrospective

Last update: 2022-06-29, 1401/04/08
Update count: 0
Registration date
2022-06-29, 1401/04/08
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
2020-07-10, 1399/04/20
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
2020-07-10, 1399/04/20
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2021-01-04, 1399/10/15
Scientific title
Evaluation of the effectiveness of logotherapy based on Rumi’s thoughts on the anxiety, depression, and distress of frontline nurses during the COVID-19 epidemic
Public title
Evaluation of the effectiveness of Logotherapy on the anxiety, depression, and distress of nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses who had been on the front lines during the Covid-19 pandemic
Exclusion criteria:
Nurses with severe psychological disorders, suicidal thoughts and those who had recently received the psychological intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
The study population was the nurses of Imam Hospital and Fatemeh Zahra Hospital. The reasons for choosing these two hospitals were that these centers have been a reference for medical referrals for Covid disease. Also, they are the main educational and medical centers of the University of Medical Sciences and Provincial Referral Center. To prevent the intervention group's concepts from being shared with the control group, each hospital was allocated to one of the two groups. In this study, the available sampling method was used. We provided an announcement in two hospitals, and then nurses interested in participating in this study registered. Finally, participants were screened by telephone and those who were eligible were included in the study.
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
2020-07-07, 1399/04/17
Ethics committee reference number
IR.MAZUMS.REC.1399.428

Health conditions studied

1

Description of health condition studied
Anxiety, Depression, Distress
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention and 1 and 3 months after the first session of the intervention
Method of measurement
Hospital Anxiety Depression Questionnaire (HADS)

2

Description
Depression
Timepoint
Before the intervention and 1 and 3 months after the first session of the intervention
Method of measurement
Hospital Anxiety Depression Questionnaire (HADS)

3

Description
Distress
Timepoint
Before the intervention and 1 and 3 months after the first session of the intervention
Method of measurement
Impact of Event Scale-Revised (IES-R)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: LBRT consists of 8 sessions: Perception of source, Self-control in the path of change, Acceptance, Adjustment with suffering and meaning-making, Dhikr and meditation (mindfulness), Death anxiety and finding the meaning of love, Patience in suffering, Gratitude. It was presented in eight sessions of 90 minutes.
Category
Treatment - Other

2

Description
Control group: they didn't 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?
Yes
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
Neuroscience
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
Specialist
Other areas of specialty/work
Neuroscience
Street address
Sari
City
Sari
Province
Mazandaran
Postal code
4816979436
Phone
+98 15 1328 3886
Fax
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
Specialist
Other areas of specialty/work
Neuroscience
Street address
Sari
City
Sari
Province
Mazandaran
Postal code
4816979436
Phone
+98 15 1328 3886
Fax
Email
shhosseini@mazums.ac.ir

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
There is no further information
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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