Protocol summary

Study aim
Comparison of the effectiveness of cognitive hypnotherapy and spiritual therapy on women with breast cancer .
Design
Thirty women with laryngeal breast cancer were randomly divided into three groups of 20 intervention and 10 control patients using a random number table. The trial phase dose not apply
Settings and conduct
The research site of Mirdamad Center in Gorgan is in the field of breast cancer. How to do the job is using a questionnaire, pre-test and post-test. Each day on a specific day, the groups undergo cognitive hypnotherapy and spiritual therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Having cancer . Not attending another psychological disorder at the same time. Having a Diploma or higher . Having 25 years old or older. Informed consent to participate. criteria for not attending : attending another psychological sessions .having another mental disorder medical.
Intervention groups
In this study, three groups are considered: Two experimental groups and one group in the control group. 30 people will be selected by available sampling and will be randomly divided into two groups of experiments and control groups. All three groups will be pre-test and post-test. and within 2 months the two experimental groups will undergo two treatment approaches
Main outcome variables
Anxiety of death, pain intensity, body image .These variables will be measured by a questionnaire in the pre-test and at the end anather measurement will be done on them through the post-test.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211109053024N1
Registration date: 2022-04-08, 1401/01/19
Registration timing: retrospective

Last update: 2022-04-08, 1401/01/19
Update count: 0
Registration date
2022-04-08, 1401/01/19
Registrant information
Name
azam soleymani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3222 1268
Email address
azamsoleymani94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cognitive hypnotherapy and spiritual therapy on death anxiety and pain intensity and body image in women with breast cancer
Public title
Comparison of cognitive hypnotherapy and spiritual therapy in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Getting cancer Absence of another psychological disorder Diploma higher education Having 25 years of age and older Conscious satisfaction for the attend meeting
Exclusion criteria:
Having another psychiatric disorder Attend other psychological sessions
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of the present study is 100 paople. 30 women with breast cancer were selected by simple random sampling method using computer random number table method and again these 30 people were randomly divided into three groups of 10 people by of computer random sampling method .1 cognitive hypnotherapy group and the spiritual therapy group and the control group that did not receive any intervention were included in this category.
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 Islamic Azad University of Bojnourd
Street address
Gorgan 7 chalebagh mehregan department
City
Bojnourd
Province
North Khorasan
Postal code
4917743630
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.IAU.BOJNOURD.REC.1400.016

Health conditions studied

1

Description of health condition studied
Women with breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Death anxiety
Timepoint
Before and after treatment
Method of measurement
Lester - questionnaire death anxiety

2

Description
Intensity of pain
Timepoint
Before and after treatment
Method of measurement
MacGill - questionnaire intensity of pain

3

Description
Physical image
Timepoint
Before and after treatment
Method of measurement
Littleton - questionnaire physical image

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Gognitive hypnotherapy is a method in which it is directly useful in correcting the main cognitions that revolve around the individual identity of self- concept and dysfunctional thoughts.In this method the ego is strengthened and the symptoms are adjusted and regulated, In 8 sessions each session will have one hour of intervention . It will be taken in the first pre-test session and in the last post- test session
Category
Treatment - Other

2

Description
Intervention group2: Spirituality therapy method that leads to greater psychological adjustment by providing supportive resources for the individual as well as indirectly by in influencing hope. also training coping strategies based on islamic teachings has a beneficial effect on health and reduce clinical pain.In 8 sessions each session will have one hour of intervention . It will be taken in the first pre-test session and in the last post- test session
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mirdamad Center
Full name of responsible person
Dr. Fariba Sabori
Street address
Behzisty Street
City
Gorgan
Province
Golestan
Postal code
4918945811
Phone
+98 17 3242 8282
Fax
+98 17 3243 7500
Email
Mirdamad.part94@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam Soleymani
Street address
Ghods 7 . Chalebagh. Gorgan
City
Gorgan
Province
Golestan
Postal code
4917743639
Phone
+98 17 3222 1268
Email
azamasoleymani94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Azam soleymani
Position
University professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ghods 7 chalebagh Gorgan
City
Gorgan
Province
Golestan
Postal code
4917743639
Phone
+98 17 3222 1268
Email
Azamasoleymani94@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam soleymani
Position
University professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Gorgan chalebagh ghods 7
City
Gorgan
Province
Golestan
Postal code
4917743639
Phone
+98 17 3222 1268
Email
azamasoleymani94@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam soleymani
Position
University professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ghods 7 Chalebagh Gorgan
City
Gorgan
Province
Golestan
Postal code
4917743639
Phone
+98 17 3222 1268
Email
azamasoleymani94@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Comparison of the effectiveness of cognitive hypnotherapy and spiritual therapy on death anxiety and pain intensity and body image in women with breast cancer
When the data will become available and for how long
Star the access period of the year 1401
To whom data/document is available
All jobs can be accessed
Under which criteria data/document could be used
As a source future research
From where data/document is obtainable
E-mail address
What processes are involved for a request to access data/document
After uploading the request , the file will be sent in the email
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