Determine the effect of Hypnotherapy on the improvement of symptoms of Asthma affected patients
Design
Clinical trial with controlled group, triple-blind, randomized
Settings and conduct
In Hypnotherapy session, in Shahid Mofateh Clinic of Yasouj City, the patient was educated about trancing, creating fatigue in the eyes and muscle relaxation, creating concentration and trance, trance deepening via strengthening imaginary and mental image, giving effective and positive suggestions specially presenting suggestions in connection with solving respiratory problems resulted from Asthma.
Participants/Inclusion and exclusion criteria
Inclusion criteria of samples included; age range of 10-60 years, having at least one year history of affection to asthma and diagnosing of asthma disease by physician.
Intervention groups
Each individual from intervention group underwent Hypnotherapy by scientific method for one session of 1.5 hours.
The control group had routine therapeutic procedure.
Main outcome variables
Asthma severity based on check-list
Forces Expiratory Volume in first second (FEV1) by Peak Flow Meter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100919004775N10
Registration date:2018-07-28, 1397/05/06
Registration timing:retrospective
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Zinat Mohebbi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
zmohebi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2008-01-16, 1386/10/26
Expected recruitment end date
2010-01-14, 1388/10/24
Actual recruitment start date
2008-03-20, 1387/01/01
Actual recruitment end date
2010-03-21, 1389/01/01
Trial completion date
empty
Scientific title
The effect of Hypnotherapy on the improvement of symptoms of Asthmatic Patients
Public title
The effect of Hypnotherapy on Improvement of Asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Showing propensity of participating in study and filling the informed consent
Age range of 10-60 years
Having at least one year history of affection to Asthma
Diagnosing of Asthma disease by physician
Exclusion criteria:
Being under therapeutic programs like Homeopathy, relaxation etc.
Age
From 10 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
4
Before, immediately, 2 weeks and 4 weeks after intervention
Actual sample size reached:
64
More than 1 sample in each individual
Actual sample size in each individual:
4
Before, immediately, 2 weeks and 4 weeks after intervention
Randomization (investigator's opinion)
Randomized
Randomization description
Samples selecting on the basis of Block Randomization sampling method
Blinding (investigator's opinion)
Triple blinded
Blinding description
The Internist, the recorder of Check-list, the person doing Peak Flow Meter and statistical advisor had no knowledge about the matter that, the under studied sample was belong to which groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasouj University of Medical Sciences
Street address
Yasouj University of Medical Sciences, near imam sajad hospital, Yasouj, Iran
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2008-01-15, 1386/10/25
Ethics committee reference number
23/5/6865/پ
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Chronic lower respiratory diseases
2
Description of health condition studied
Asthma
ICD-10 code
J40-J47
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthma ِDisease Severity
Timepoint
Before intervention, immediately, 2 weeks and 4 weeks after intervention
Method of measurement
The checklist was originated from guideline table of diagnosis and treatment of Asthma that has been published by national institute of Health, Heart, Lung and Blood
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each individual from intervention group underwent Hypnotherapy by scientific method for one session of 1.5 hours. In this session, the patient was educated about trancing, creating fatigue in the eyes and muscle relaxation, creating concentration and trance, trance deepening via strengthening imaginary and mental image, giving positive and effective suggestions specially presenting suggestions in connection with solving respiratory problems resulted from Asthma that the patient performed them simultaneously. Lightening trance and bringing out the patient from it was carried out at the end.
Category
Other
2
Description
Control group: Asthma disease treatment with routine process was just carried out for this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Clinic of Yasouj City
Full name of responsible person
Zinat Mohebbi
Street address
Nursing and midwifery college, namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
mohebbi04@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Zoladl
Street address
Yasouj University of Medical Sciences, near the Immam Sajad hospital
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Fax
+98 74 3323 4115
Email
M_zoladl@yahoo.com
Grant name
Grant code / Reference number
6865
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Assistant professor in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery college, Nemazi Squer
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4256
Email
mohebbi04@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Assistant professor in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery college, Nemazi Squer
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4257
Email
mohebbi04@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Assistant professor in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery college, Nemazi Squer
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4257
Email
mohebbi04@yahoo.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