Protocol summary

Study aim
Evaluation of the effectiveness of training in Neuro Linguistic programming strategies on social anxiety and quality of life in patients with acquired immunodeficiency
Design
Randomized clinical trial with intervention and control groups
Settings and conduct
This clinical trial will be performed in the Behavioral Diseases Counseling Center located in Imam Khomeini Hospital in Tehran, so that in the intervention group, the participants will be trained and consulted, while in the control group, no intervention will be performed. Also, randomization will be done as a block and since patients understand the intervention compared to the control group, this study will be done as Open Labale. Data analysis by comparing the two groups of intervention and control with Each other as well as pre-test and post-test will be done in each group.
Participants/Inclusion and exclusion criteria
1.Acquired immunodeficiency virus 2.Having social anxiety disorder
Intervention groups
1.The intervention group includes individuals / patients with acquired immunodeficiency who have social anxiety disorder (phobia) who receive educational and counseling intervention for Neuro Linguistic Programming. 2.The control group includes individuals / patients with acquired immunodeficiency who have social anxiety disorder (phobia) who participate only in the pre-test and post-test and no intervention is done for them.
Main outcome variables
Evaluation of the effectiveness of training psychological strategies for Neuro Linguistic programming in the rate of social anxiety disorder and quality of life in patients with acquired immunodeficiency.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201018049067N1
Registration date: 2021-11-24, 1400/09/03
Registration timing: registered_while_recruiting

Last update: 2021-11-24, 1400/09/03
Update count: 0
Registration date
2021-11-24, 1400/09/03
Registrant information
Name
Hosein Alizadeh barough
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4463 0874
Email address
aarmani823@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of training neuro linguistic programming strategies on the rate of social anxiety disorder and quality of life in patients with acquired immunodeficiency
Public title
The effect of teaching neuro linguistic programming strategies on the level of social anxiety disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Acquired immunodeficiency virus Having social anxiety disorder
Exclusion criteria:
Patients with acquired immunodeficiency disease for less than (3) three years. Affected individuals whose daily functioning and hope for the future and self-efficacy are not impaired.
Age
From 10 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a total of 30 people, 15 people in the intervention group and 15 people in the control group, will be included, according to the sample size intended to prevent imbalance in the number of people participating in the study in a randomized method. Simple simulation happens and researchers intend to use the Block Randomazition method. The use of this method causes a balance between the two groups, which in the sample size is less than 100 recommendations for randomization with this method. Therefore, in this study, using a table of random numbers, blocks of six or 6 people are formed and these blocks are assigned to two groups of intervention and control.
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 Islamic Azad University, ARDABIL
Street address
.Islamic Azad University Complex, Ardabil Branch.Basij square.
City
ARDABIL
Province
Ardabil
Postal code
5615731567
Approval date
2021-09-11, 1400/06/20
Ethics committee reference number
IR.IAU.ARDABIL.REC.1400.041

Health conditions studied

1

Description of health condition studied
social anxiety disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias

Primary outcomes

1

Description
Social Anxiety Score
Timepoint
At the beginning of the study (before the intervention) and 3 months after the intervention
Method of measurement
Quality of Life Questionnaire, Social Anxiety, Death Anxiety, Resilience and Hardiness Scale

2

Description
Quality of Life
Timepoint
At the beginning of the study (before the intervention) and 3 months after the intervention
Method of measurement
Connor Social Panic Questionnaire (SPIN) and Quality of Life Questionnaire (SF-12) Short Form, Templer Death Anxiety Scale Questionnaire, Connor and Davidson Resilience Scale Questionnaire CD-RISC and Ahvaz Stubbornness Questionnaire 27

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A group of 15 people with acquired immunodeficiency disease. The research and intervention process is as follows: First, the pre-test stage by distributing a questionnaire with the fields of social anxiety, death anxiety, quality of life, resilience, hardiness and After that, he enters the interview stage individually and after observing and taking the patient's history by the researcher, he examines the visual and perceptual system (visual, auditory, tactile) of the patient by his 5 senses and then 3 simultaneous techniques that include: 1. Empathy 2. Establish effective communication 3. Leadership in the treatment and intervention situation should be implemented. He then performs an ecological test to see if the problem is resolved or remains, and immediately performs the future pace technique so that the patient can visualize himself in the future and observe his behavior and position in the future. It then performs a basic technique called the root technique, asking: Step (1) Ask the patient what the problem is now. And here the patient looks at the problem from the outside world and expresses his observations. Step (2) If the problem persists, the patient looks at the problem again from the outside world and explains the new observation. Step (3) If the problem was solved, we came to a conclusion, but if it remained, Step (4) again We repeat the steps until the result is obtained, and after obtaining the result, the researcher again uses the technique of taking it to the future and the ecological test to observe and record the effect of implementing the technique and achieving a change in the patient's mood and solving the patient's problem.
Category
Behavior

2

Description
Control group: For this group, only the questionnaire form is distributed with the fields of social anxiety, death anxiety, quality of life, resilience, and hardiness and After 3 months from the pre-test stage, it enters the post-test stage and the questionnaires are distributed again.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran AIDS Research Center
Full name of responsible person
Minoo Mohraz
Street address
Iran AIDS Research Center.(Building 6).Behind the Infectious Building.Imam Khomeini Hospital Complex.The end of Keshavarz Boulevard.Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Fax
+98 21 6694 7984
Email
ircha@sina.tums.ac.ir
Web page address
https://ircha.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. sahraeian
Street address
5th floor. the headquarters of Tehran University of Medical Sciences,corner of Ghods St.Keshavarz Blvd.Tehran Town
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Int. Academy of NLP & Coching prof.Omraie
Full name of responsible person
prof.Reza Omraie
Street address
No. 2,Aksa Building,8th Floor,Unit 22,Above Kolahdooz,South KavehBoulevard
City
Tehran
Province
Tehran
Postal code
1939893392
Phone
+98 21 2660 0001
Fax
+98 21 2660 0001
Email
info@innlpacademy.com
Web page address
http://www.innlpacademy.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Int. Academy of NLP & Coching prof.Omraie
Proportion provided by this source
50
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hosein Alizadeh Barough
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Valiasr St .Islamic Azad University, Khalkhal Branch.Psychology College
City
Khalkhal
Province
Ardabil
Postal code
5681731367
Phone
+98 45 3245 1220
Email
aarmani823@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
SeyedAhmad SeyedAlinaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
End of Keshavarz Boulevard, Imam Khomeini Hospital, behind the Infectious Diseases Department, Iran AIDS Research Center.Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Fax
+98 21 6694 7984
Email
s.a.alinaghi@gmail.com
Web page address
https://ircha.tums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esa Jafari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Payame Noor University St. Payame Noor Center.Ardebil Faculty of Psychology.Ardebil Town
City
Ardebil
Province
Ardabil
Postal code
5619913115
Phone
+98 45 3352 2913
Fax
+98 45 3352 2913
Email
dr.jafari@pnu.ac.ir
Web page address
http://ardebil.pnu.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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