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The Effect of Cognitive-Emotional Training on Post-Traumatic Stress and Post-Traumatic Growth in Women with Breast Cancer

Protocol summary

Study aim
The purpose of this study was to determine the effect of cognitive-emotional training on stress and post-traumatic growth in women with breast cancer.
Design
In this study, 90 patients with breast cancer who were admitted to Imam Ali Hospital in Zahedan were selected and randomly divided into two intervention and control groups.
Settings and conduct
Both intervention and control groups performed pre-test by completing posttraumatic growth Inventory and the posttraumatic stress disorder checklist. The intervention group received 5 emotional cognitive education sessions based on specified content. Educational sessions were established in a hospital, clinic or in the Zahedan Nursing and Midwifery Faculty, based on agreement with patients and presence of facilities.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 20 years of age, at least reading and writing skill, passing at least 6 months and maximum 5 years from diagnosis. Exclusion criteria: presence of metastasis according to the patient's document
Intervention groups
The intervention group received 5 sessions of emotional cognitive education program in two sessions per week. Education was provided based on specified content through group education in which each group consisted of 4 to 8 members. Sessions included: An overview of the disease, psychosocial consequences, and the process of treating the disease, normalizing emotional reactions to cancers, teaching and practicing emotional disclosure and emotion evacuation, self-regulation of emotions, facilitating and practicing cognitive processing and deliberate mental rumination, developing values and priorities New values, redefine goals, and create a new philosophy for life, spirituality, positive thinking, and teaching patience. During this period, the control group did not receive any intervention other than the usual treatment plan.
Main outcome variables
Post traumatic growth and post traumatic stress.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160924029954N4
Registration date: 2017-11-26, 1396/09/05
Registration timing: retrospective

Last update: 2017-11-26, 1396/09/05
Update count: 0
Registration date
2017-11-26, 1396/09/05
Registrant information
Name
Ali navidian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
alinavidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2017-05-07, 1396/02/17
Expected recruitment end date
2017-10-09, 1396/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive-Emotional Training on Post-Traumatic Stress and Post-Traumatic Growth in Women with Breast Cancer
Public title
The Effect of Cognitive-Emotional Training on Post-Traumatic Stress and Post-Traumatic Growth
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
At least 20 years old. Having at least the ability to read and write. Passing at least 6 months and maximum 5 years from the diagnosis Not passing more than 5 years from the diagnosis Absence of cognitive impairment and mental disorders. Absence of any recent crises experience other than cancer in life Not being under any specific training program.
Exclusion criteria:
presence of metastasis according to the patient's document
Age
From 76 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were randomly assigned to intervention and control groups. First, the total number of subjects enrolled in the envelope containing the study groups (A intervention and control B) was prepared and randomly sorted. Gradually, by identifying the eligible person, one of the envelopes was allocated to the selected individuals, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
At first, the total number of subjects studied, the envelope containing the A intervention and the control B, were prepared and randomly sorted and then assigned to the selected individuals.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences & Health Services
Street address
Administrative Complex of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
IR.ZAUMS.REC.1396.21

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Post traumatic growth
Timepoint
Before intervention - Three months after the intervention
Method of measurement
Post traumatic growth inventory

2

Description
Post traumatic stress disorder
Timepoint
Before intervention - Three months after the intervention
Method of measurement
Post traumatic stress disorder checklist

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group receives 5 sessions of cognitive-emotional training sessions in two sessions a week, ranging from 4 to 8 people and based on the content assigned and each session is an average of 90 minutes.
Category
Other

2

Description
The control group, with the exception of the usual treatment program, does not receive any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb's hospital in Zahedan
Full name of responsible person
Parvaneh Hamidyan
Street address
Ali Ebne Abi Taleb's hospital in Zahedan, Khalije Fars Blvd، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
p.hamidyan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nour Mohammad Bakhshani
Street address
Administrative Complex of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
p.hamidyan@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Parvaneh Hamidyan
Position
Master Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery، Mashahir Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 34 4421 7577
Fax
Email
p.hamidyan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Nursing and Midwifery, Mashahir Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Fax
Email
alinavidian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parvaneh Hamidyan
Position
Master Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery، Mashahir Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 34 4421 7577
Fax
Email
p.hamidyan@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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