Protocol summary

Summary
The purpose of this study is to evaluate the effectiveness of hypnosis in ‎reducing pain symptoms in patients that suffered from psychosomatic ‎disorders. The inclusion of study involves the diagnosis of ‎psychosomatic disorders among people having pain symptoms and ‎suffered from it. ‎ Exclusion of study involves lack of cooperation and malingering during ‎intervention. The population consists of all patients who suffered from ‎somatic disorders that from 22 may 2015 admitted in psychosomatic ‎section of Chamran martyr hospital in Shiraz and psychiatric wards of ‎Medical Sciences in Shiraz University. Sample size involves 22 people ‎for both intervention and control groups. Hypnosis sessions for each of ‎these groups are estimated about 8 sessions over two weeks, when control ‎group treated with hypnosis, no treatment was performed and at the same ‎time they benefited from standard drug treatment .in the case of pain; ‎both groups were compared with each other. In addition to the standard ‎drug treatment intervention group, behavioral intervention can be done ‎by hypnotherapy. Hypnosis sessions for each of experimental group ‎considered about 8 meetings in two weeks. After test, in terms of pain ‎both groups will be compared with each other.‎

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050520378N1
Registration date: 2015-07-11, 1394/04/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-11, 1394/04/20
Registrant information
Name
seyed ali dastgheib
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
adastgheib@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-03-23, 1394/01/03
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of hypnotherapy in reducing the symptoms of pain in patients with psychosomatic disorder
Public title
The effectiveness of hypnosis in the treatment of psychosomatic pain
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion of study involves the diagnosis of psychosomatic disorders among people having pain symptoms and suffered from it. Exclusion of study involves lack of cooperation and malingering during intervention.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
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
Shiraz University of Medical Sciences
Street address
Shiraz, Hafez Hospital, Chamran Blvd.
City
Shiraz
Postal code
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
CT- P- 9382-8592

Health conditions studied

1

Description of health condition studied
Psychosomatic disorder
ICD-10 code
F45.0
ICD-10 code description
Hypnotherapy can unconsciously be effective in symptoms and pain ‎reductions in the patient.‎

Primary outcomes

1

Description
Pain Reduction
Timepoint
After two week
Method of measurement
Pain-using McGill Pain Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the experimental group, in addition to traditional drug treatment, behavioral interventions can be done with hypnotherapy.Treatment protocol consists of 8 sessions of hypnotherapy, which pain reduction suggestion is given to the patient.
Category
Behavior

2

Description
The control group received only traditional drug therapy in reducing pain in handling psychosomatic disorders.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Chamran Hospital and other Health Centers in Shiraz Psychology
Full name of responsible person
Seyed Ali Dastghayb
Street address
Shiraz, Chamran Blv, Hafez HospitalPsychiatric Ward
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ali Dastghayb
Street address
Shiraz, Iran Chamran, Hafez Hospital psychiatric ward
City
SHIRAZ
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Shahsavari Shirazi
Position
Master of Science in Psychology
Other areas of specialty/work
Street address
Shiraz, Iran Syahtgr, Alley 45, No. 27
City
SHIRAZ
Postal code
Phone
+98 71 3821 6143
Fax
Email
EHSANSHAHSAVARI.META@GMAIL.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ali Dastghayb
Position
Psychiatrist
Other areas of specialty/work
Street address
Shiraz, Iran Chamran, Hafez Hospital psychiatric ward
City
Shiraz
Postal code
71946-34786
Phone
+98 71 3627 1531
Fax
Email
adastgheib@sums.ac.ir
Web page address

Person responsible for updating data

Contact

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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