Protocol summary

Summary
Background: Multiple sclerosis is an autoimmune disease that create Family disruption , economic hardship and psychological distress . Although there is no cure for this disease, but psychotherapy or use complementary therapies to reduce symptoms of the disease have been effective. The aim of this study is to assess the effectiveness of cognitive group hypnotherapy on psychological well-being in patients with multiple sclerosis is Yasuj. Methods: This study is a clinical trial. A total of 30 patients with multiple sclerosis who have been admitted to the Mofateh clinic in Yasuj selected and randomly assigned into experimental and control group. For experimental group 8 sessions for one and a half hours of weekly cognitive hypnotherapy will be treated but control group received no intervention. This Reef psychological well-being questionnaire (Short Form 21-item) will be used to assess psychological well-being. Before and after the intervention, both groups will fill the questionnaire. The gathered data will be analyzed using SPSS 23.

General information

Acronym
group cognitive Hypnotherapy
IRCT registration information
IRCT registration number: IRCT2017041129377N2
Registration date: 2017-06-08, 1396/03/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Mohammad Malekzadeh
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3332 3379
Email address
mohamad.malekzadeh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical sciences
Expected recruitment start date
2016-11-28, 1395/09/08
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group cognitive hypnotherapy on Psychological well-being in patients with multiple sclerosis.
Public title
Effect of Cognitive hypnotherapy in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients should have volunteered to participate in this study.Informed consent form to be completed. Only patients that diagnosed with multiple sclerosis will participated in the study. Exclusion criteria: Patients with chronic diseases such as asthma, epilepsy and cardiovascular disease, the use of psychiatric medications, delays and irregularities in the hypnosis sessions, Sudden illness or severe colds, lack of any talent for hypnosis. and patients who had a history of suicide or those who have suicidal thoughts will not participated in study.
Age
From 18 years old to 43 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Vice President of ResearchYasuj University of Medical Sciences
City
Yasuj
Postal code
7591741417
Approval date
2015-11-28, 1394/09/07
Ethics committee reference number
IR.YUMS.REC.1394.107

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Incl.: Multiple sclerosis (of): NOS brain stem cord disseminated generalized

Primary outcomes

1

Description
Psychological well-being
Timepoint
]t will be measured at the baseline and 2 months after the intervention.
Method of measurement
Psychological Well-Being Scale Ryfe

Secondary outcomes

empty

Intervention groups

1

Description
Cognitive Hypnotherapy For experimental group 8 sessions for one and a half hours of weekly cognitive hypnotherapy will be applied. The use of cognitive techniques Identify cognitive distortions Negative thoughts and cognitive restructuring
Category
Treatment - Other

2

Description
Control group the control group will not receive any intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofateh clinic and Beheshti hospital
Full name of responsible person
Mr. Zabihi
Street address
Hospital pharmacist, Shahid Beheshti hospital, Yasuj
City
yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Hossein Mary Oriad, Vice Chancellor for research of Yasuj University of Medical Sciences
Street address
jahad Agriculture
City
yasuj
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Yasu University of Medical Sciences
Full name of responsible person
Mohammad Malekzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences
City
yasuj
Postal code
Phone
+98 917 145 4340
Fax
Email
mzh541@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Mohammad Malekzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences - Deputy for Research and technology.
City
yasuj
Postal code
Phone
00
Fax
Email
mzh541@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
Mohammad Malekzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences
City
Postal code
Phone
00
Fax
Email
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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