Protocol summary

Summary
(1) Objective: Comparing the effectiveness of group hypnotherapy with education of spiritual intelligence components on Medical Science student’s anxiety (2) Design: Field trial study (3) Setting and conduct: After measurement of the trait and state anxiety as pretest, eligible students will assignee through block random allocation to intervention group 1, intervention group 2, and control group. While the control group won't receive any interventions, research interventions will done in intervention group 1 and intervention group 2 during 5 weeks. The level of trait and state anxiety of all study subjects will be measured immediately after research interventions (post-test) and one months after completion of study interventions (follow-up) using the Spielberger anxiety inventory, and will be compared. (4) Participants including major eligibility criteria: 75 Medical students of Yasuj University of Medical Sciences and Larestan Faculty of Medical Sciences who are without any chronic physical disorder and mental diseases, with score equal 43 and higher in both trait and state anxiety, and complete written informed consent (5) Intervention: The intervention group 1 will receive five 90 minute session of group hypnotherapy in 5 weeks, and the experimental group 2 will receive eight 90 minute session of education of spiritual intelligence components in 5 weeks. (6) Main outcome measures (variables): The level of trait and state anxiety that will be measured using the Spielberger anxiety inventory.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041627410N1
Registration date: 2016-09-18, 1395/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-18, 1395/06/28
Registrant information
Name
Zabih Allah Khoshdeli
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7251
Email address
zkhoshdel@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research and technology of Yasuj University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of impact of group hypnotherapy and education of spiritual intelligence components on anxiety of medical sciences students
Public title
Impact of group hypnotherapy and education of spiritual intelligence components on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Student of Yasuj University of Medical Sciences or Larestan Faculty of Medical Sciences;Lack of chronic physical illness; Lack of mental illnesses; The score of both trait and state anxiety in Spielberger anxiety inventory will equal 43 and higher; Completion of written informed consent. Exclusion criteria will: Lack of motivation to continue the study; Diseases or conditions that can’t to continue the study; Excessive fatigue; Immigration; Death
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
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 Yasuj University of Medical Sciences
Street address
Deputy of research and technology, Yasuj University of Medical Science, Shahid Motahari Blvd., Yasuj, Iran
City
Yasuj
Postal code
7591741417
Approval date
2016-04-30, 1395/02/11
Ethics committee reference number
IR.YUMS.REC.1395.23

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety NOS

Primary outcomes

1

Description
trait anxiety
Timepoint
At the beginning of the study; immediately after completion of research interventions(post test); One month after the end of research interventions(follow up)
Method of measurement
score of Spielberger state-trait anxiety inventory

2

Description
state anxiety
Timepoint
At the beginning of the study; immediately after completion of research interventions(post test); One month after the end of research interventions(follow up)
Method of measurement
score of Spielberger state-trait anxiety inventory

Secondary outcomes

empty

Intervention groups

1

Description
Five 90 minute session of group hypnotherapy during 5 week in intervention group 1
Category
Behavior

2

Description
Eight 90 minute session of education of spiritual intelligence components during 5 week in intervention group 2
Category
Behavior

3

Description
No intervention in control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj Faculty of Medicine
Full name of responsible person
Dr. Seyed Mohammad Reza Rabani
Street address
Shahid Dr.Jalil Street
City
Yasuj

2

Recruitment center
Name of recruitment center
Yasuj Faculty of Dentistry
Full name of responsible person
Dr. Seyedeh Zeinab Behroozi
Street address
Shahid Dr.Jalil Street
City
Yasuj

3

Recruitment center
Name of recruitment center
Yasuj Faculty of Nursing and Midwifery
Full name of responsible person
Dr. Kheirollah Noorian
Street address
Shahid Dr.Jalil Street
City
Yasuj

4

Recruitment center
Name of recruitment center
Yasuj Faculty of Health
Full name of responsible person
Dr.Janmohammad Malekzadeh
Street address
Pasdaran Street
City
Yasuj

5

Recruitment center
Name of recruitment center
Yasuj Faculty of Paramedicine
Full name of responsible person
Dr.Mohsen Salari
Street address
Shahid Dr.Jalil Street
City
Yasuj

6

Recruitment center
Name of recruitment center
Lar Faculty of Medical Sciences
Full name of responsible person
Dr. Atefeh Raoufi
Street address
Lar-Gerash Road, next to Imam Reza Hospital
City
Larestan

7

Recruitment center
Name of recruitment center
Lar Hazrat Zeinab Faculty of Nursing and Midwifery
Full name of responsible person
Mr. Mohammad Reza Foroutani
Street address
Lar-Gerash Road, next to Imam Reza Hospital
City
Larestan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research and technology of Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mehdi Akbartabar Touri
Street address
Research manager office, Deputy of research and technology, Yasuj University of Medical Science, Shahid Motahari Blvd, Yasuj, Iran
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. KHeirollah Nooryan
Position
PhD of psychiatric nursing- Assistant Professor & Dean of Faculty
Other areas of specialty/work
Street address
Faulty of Nursing and Midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
khnooryan@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zoladl
Position
PhD of psychiatric nursing- Associate Professor
Other areas of specialty/work
Street address
Faulty of Nursing and Midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
zoladl.mohammad@yums.ac.ir; zoladl@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Zabih Allah KHoshdeli
Position
Ms student of psychiatric nursing
Other areas of specialty/work
Street address
Faulty of Nursing and Midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street, Yasuj, Iran
City
Yasuj
Postal code
Phone
00
Fax
Email
zkhoshdel@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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