Protocol summary

Summary
This study aimed to investigate the effect of hypnosis on pain management, anxiety, death, resiliency and recovery of cancer cells in patients with acute myeloid leukemia were treated with chemotherapy. The research method was quasi-experimental, pretest-posttest control group was unequal. Statistical population All patients with acute myeloid leukemia chemotherapy clinics gardener and Imam Khomeini hospital in Sari city Medical records and tested with flow cytometry in the diagnosis of acute myeloid leukemia who were 86 in number And sample 26 to sample selected and the two groups (n = 13) and control group (n=13) were randomly. Questionnaires to collect information from the sample group were considered included Czech questionnaire lists the McGill Pain( MPQ), Leicester cult of death anxiety(CL-FODS), Resilience and Davidson(CD-RIS), And flow cytometry experiments reviews of marker CD4 to CD8 AndThe ratio of CD4 to CD8 And the percentage of lymphocytes in the peripheral blood. The experimental group was six sessions of therapeutic hypnosis.

General information

Acronym
Hypnosis
IRCT registration information
IRCT registration number: IRCT2015010314928N2
Registration date: 2016-06-18, 1395/03/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Mehdi Pourasghar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3327 3024
Email address
m.pourasghar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-26, 1394/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Hypnosis On Pain Control, Anxiety Death, Resiliency And Cure Of Cancer Cells In Patient With Acute Myeloid leukemia Chemotherapy
Public title
The Effect Hypnosis On Acute Myeloid leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age group between 18 and 50 years- completed consent form to participate in the plan- absence of severe depression with- absence seizures are not controlled- absence of anti social character- psychosis had no- medical record at the clinic of Imam Khomeini hospital- gardener and get diagnosed acute myeloid leukemia by flow cytometry test Exclusion criteria: Each treatment when the patient can be removed from the plan.- The experimental group hypnosis therapy done by indoctrinating during six 40-minute sessions- control group received hypnosis therapy- gardeners with no medical record at the clinic and Imam Khomeini hospital in Sari city- with no testing of flow cytometry for the detection of acute myeloid leukemia
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sealed envelope

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic azad university sari branch
Street address
Farah Abad Complex 9 km of roads Islamic Azad University
City
Sari
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
20820701941111

Health conditions studied

1

Description of health condition studied
acute myeloid
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukaemia, minimal differentiation Acute myeloblastic leukaemia (with maturation) AML1/ETO AML M0 AML M1 AML M2 AML with t(8;21) AML (without a FAB classification) NOS Refractory anaemia with excess blasts in transformation Excl.: acute

Primary outcomes

1

Description
Pain
Timepoint
Before Intervention In The First Session And After The last Intervention At An Interval Of 3 Months In The last Session
Method of measurement
Inventory McGill Pain Management

2

Description
Anxiety Death
Timepoint
Before Intervention In The First Session And After The last Intervention At An Interval Of 3 Months In The last Session
Method of measurement
Questionnaires Collett-Lester Anxiety Death

3

Description
Resiliency
Timepoint
Before Intervention In The First Session And After The last Intervention At An Interval Of 3 Months In The last Session
Method of measurement
Questionnaires Resilience Cooner And Davidson

4

Description
Cure Of Cancer Cells
Timepoint
Before Intervention In The First Session And After The last Intervention At An Interval Of 3 Months In The last Session
Method of measurement
Flow Cytometry Tests To Measure CD4 And CD8 Markers Aand Measuring The Ratio Of CD4 To CD8 lymphocyte Percentage ,easurements

Secondary outcomes

empty

Intervention groups

1

Description
The control group did not receive hypnosis therapy in the treatment of related audio hypnosis sessions were provided
Category
Other

2

Description
First meeting: Introduction to Trading Had- AML patients with Hypnosis- view color images of standard questions related to sexual disease medications, chemotherapy expectations, relaxation and get public records to assess the hypnotic swaying testing consent form writing- Trading and Inventory management of patients with hypnosis and pain, death anxiety, resilience and testing, flow cytometry- The second session control room relaxing- get relaxed setting in a mental space dictates of the forest and listen to calming music- Third session: get pain management dictates associated with increased feelings of physical and good feeling pain management and at the same time listening to calming music- Fourth session: Anxiety swing Vry- received death dictates of hope to increase life expectancy reminder of past business success business success and improve
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital in Sari city
Full name of responsible person
Dr Ghasem Janbabai
Street address
Street Amir Mazndrany
City
Sari

2

Recruitment center
Name of recruitment center
Gardener Clinic Sari
Full name of responsible person
Dr ghasem janbabai
Street address
Caspian Field
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Vice President of Research Phd mohammad farsi
Street address
9 km road Farah Abad Complex Islamic Azad University
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Sari Branch
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
Mazandaran University of Medical Sciences
Full name of responsible person
Ghasem Janbabai
Position
Specialty of oncology/Associate of Professor
Other areas of specialty/work
Street address
Imam Square Tee Mazandaran University of Medical Sciences streams office
City
Sari
Postal code
Phone
+98 15 1327 3024
Fax
Email
janbabai@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
mehdi pourasghar
Position
Psychiatrist
Other areas of specialty/work
Street address
Caspian Boulevard Complex field of mind and dynamic behavior
City
Sari
Postal code
Phone
+98 911 113 5010
Fax
Email
m_pourasghar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Of Sari Branch
Full name of responsible person
Fatemeh Fathi
Position
Master Cilinical Psychology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
fatemeh_fathi67@yahoo.com
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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