Protocol summary

Study aim
Developing a treatment protocol for generalized anxiety disorder, based on the basic model of anxiety diagnosis from the perspective of the Quran, determining and comparing the anxiety of women with sinus tachycardia caused by anxiety, in the intervention and control groups before, immediately after and one month after the intervention.
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized, sample size of 15 people in each group
Settings and conduct
The control group is given heart rate reducing drug (propranolol) for one month, and at the same time, in the experimental group, the origin of the anxiety of the people was determined according to the diagnostic system of the Holy Quran, and their anxiety patterns were identified, and according to that, the relevant treatment strategies were given during individual counseling sessions for a period of two months. is presented. The follow-up in both the control and experimental groups was done after 1 month from the end of the respective treatments, and the final anxiety score of the experimental group It is compared with the previous score
Participants/Inclusion and exclusion criteria
The inclusion criterion is having generalized anxiety disorder and the absence of co-occurring affective disorder, the exclusion criterion is lack of companionship in the treatment process or suffering from a disease or accident affecting anxiety.
Intervention groups
In the intervention group, treatment developed according to the Holy Quran is provided during weekly and individual sessions, and anxiety levels are measured after the end of the treatment period.
Main outcome variables
physical signs of anxiety; Psychological symptoms of anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230123057186N1
Registration date: 2023-12-31, 1402/10/10
Registration timing: retrospective

Last update: 2023-12-31, 1402/10/10
Update count: 0
Registration date
2023-12-31, 1402/10/10
Registrant information
Name
Zahra sadat Mirzahosein lashgar nevis hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7711 5304
Email address
heliahoseini96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2022-10-02, 1401/07/10
Actual recruitment start date
2022-09-01, 1401/06/10
Actual recruitment end date
2022-10-02, 1401/07/10
Trial completion date
2022-12-31, 1401/10/10
Scientific title
Developing a treatment protocol for pervasive anxiety disorder based on the teachings of the Holy Quran and investigating its effectiveness on the anxiety level of women with sinus tachycardia caused by anxiety
Public title
Investigating the effectiveness of Quranic treatment of generalized anxiety disorder on anxiety levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having sinus tachycardia Evidence of anxiety and certainty of anxiety diagnosis (by clinical interview and Beck anxiety questionnaire) Not suffering from uncontrolled cardiac or non-cardiac underlying disease affecting the physical symptoms of anxiety (such as tachycardia), including hyperthyroidism, fever, hypoglycemia, pheochromocytoma, bleeding, consumption of stimulants such as caffeine, congenital cardiac arrhythmias such as AVNRT or AVRT or AF, heart failure, congenital heart disease, ischemic heart disease, rheumatic heart disease Having a minimum literacy of reading and writing Having consent to participate in the research Belief and commitment to the fundamentals of Islam
Exclusion criteria:
suffering from a disease affecting the physical symptoms of anxiety during the study period Failure to follow up treatment and failure to participate in two consecutive treatment sessions The occurrence of an unexpected and extremely anxiety-provoking incident that takes a person out of the normal state (such as the experience of bereavement of loved ones, accidents, earthquakes, fires, etc.)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after determining the statistical population, randomization was done using the random number table method. Each member of the community was assigned a number in the table and the researcher made a random selection by closing his eyes and placing his finger or pen tip on the table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are aware of the type of intervention that has been done for them (drug treatment or psychotherapy). Also, clinical caregivers are aware of the treatment they have provided. The researcher who evaluated and analyzed the data is not aware of the type of intervention during the data analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Azad University of Tehran, Department of Medical Sciences
Street address
Unit 925, 2th floor, No.14, Shaghayegh 14 Building, shahrak Beheshti Ave, Bababie Free way
City
Tehran
Province
Tehran
Postal code
1651113364
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.IAU.TMU.REC.1399.278

Health conditions studied

1

Description of health condition studied
Treatment of pervasive anxiety disorder according to the teachings of the Holy Quran
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety score in Beck's questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, one month after the end of the intervention
Method of measurement
Beck's anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: women with sinus tachycardia caused by anxiety, who are treated with Quranic psychotherapy for generalized anxiety disorder for two months and in weekly and individual sessions.
Category
Treatment - Other

2

Description
Control group: women with sinus tachycardia caused by anxiety who are treated with propranolol
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bo Ali Hospital
Full name of responsible person
Zahra Sadat Mirzahosein Lashgar Nevis Hoseini
Street address
Imam Hossein Square, Damavand Street, Bu Ali Hospital
City
Tehran
Province
Tehran
Postal code
1651113364
Phone
+98 21 3334 8036
Email
heliahoseini96@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gelaleh Shahabpour
Street address
Zargandeh, Dr. Shariati Street, Imamzadeh Street, Attari Moghadam Street
City
Tehran
Province
Tehran
Postal code
1651113364
Phone
+98 21 2200 6660
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Zahra Sadat Mirzahosein Lashgar Nevis Hoseini
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 925, 2th floor, No.14, Shaghayegh 14 Building, shahrak Beheshti Ave, Bababie Free way
City
Tehran
Province
Tehran
Postal code
1651113364
Phone
+98 21 7711 5304
Email
heliahoseini96@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Sadat Mirzahosein Lashgar Nevis Hoseini
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 925, 2th floor, No.14, Shaghayegh 14 Building, shahrak Beheshti Ave, Bababie Free way
City
Tehran
Province
Tehran
Postal code
1651113364
Phone
+98 21 7711 5304
Email
heliahoseini96@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Sadat Mirzahosein Lashgar Nevis Hoseini
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 925, 2th floor, No.14, Shaghayegh 14 Building, shahrak Beheshti Ave, Bababie Free way
City
Tehran
Province
Tehran
Postal code
1651113364
Phone
+98 21 7711 5304
Email
heliahoseini96@gmail.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
Due to privacy
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
No - There is not 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 protocol for the treatment of generalized anxiety disorder according to the Holy Quran will be published in full or in brief and practical
When the data will become available and for how long
Since 2024
To whom data/document is available
Psychologists, psychiatrists, counselors and interested people
Under which criteria data/document could be used
In order to be used to learn more about the wonderful miracles of the Holy Quran and to learn about the spiritual-religious treatment of anxiety
From where data/document is obtainable
It will be publicized in the future
What processes are involved for a request to access data/document
It will be publicized in the future
Comments
Loading...