Protocol summary

Study aim
Determining the Effectiveness of Spiritual and Emotional Intelligence Training on Stigma and Human Dignity in Cancer Patients
Design
In this randomized controlled trial, 75 patients with cancer were selected as available. They were randomly assigned to three groups of emotional intelligence training, spiritual intelligence training and control group.
Settings and conduct
This study was carried out in Omid's Oncology Hospital in Mashhad. After receiving written consent, people with cancer were invited to participate in the study if they were eligible to enter the study and then were randomly assigned to three intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Awareness of cancer diagnosis, Stage I or II cancer according to pathological tests, The lack of mental and physical disorders simultaneously, No referral to psychiatry due to psychiatric problems during the past 6 months, Get a score of over 50 from the MMSE Short Psychiatric Examination Exclusion criteria: Absence of a meeting and more in intervention sessions
Intervention groups
Emotional Intelligence Training: The emotional intelligence concepts were taught during the 10 sessions of 1/5 hour based on the training package of Salvovey & Mayer. Spiritual Intelligence Training: The spiritual intelligence concepts were taught during the 10 sessions of 1/5 hours based on the training package of King's Model (2008).
Main outcome variables
cancer Stigma human Dignity Spiritual Intelligence Emotional Intelligence

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT20180509039597N1
Registration date: 2018-06-02, 1397/03/12
Registration timing: registered_while_recruiting

Last update: 2018-06-02, 1397/03/12
Update count: 0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Azam Salarhaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3763 1093
Email address
salarha961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-07, 1397/02/17
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spiritual with Emotional Intelligence Training on Stigma and Human Dignity in Patients with Cancer
Public title
Effect of Spiritual with Emotional Intelligence Training on Stigma and Human Dignity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The definitive diagnosis of cancer by a Oncologist at least high school level Awareness of cancer diagnosis Stage I or II cancer according to pathological tests No substance abuse or drug abuse The lack of mental and physical disorders simultaneously No referral to psychiatry due to psychiatric problems during the past 6 months Get a score of over 50 from the MMSE Short Psychiatric Examination
Exclusion criteria:
Lack of participation in post-test Absence of a meeting and more in intervention sessions Unwillingness to continue to participate in the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
The random numbers table were assigned to three intervention and control groups. A list of eligible patients was prepared and assigned a number to each of them. Then, a randomly selected number was selected randomly from the random numbers table and two digits to the right of it were considered. If the two digits on the right match the number of people listed, they were selected as the first person in the control group and Subsequently, the numbers (in the case of the number of persons listed) were assigned to the emotional intelligence training group and spiritual intelligence training, respectively. This will continue until sample size (25 people per group) is completed.
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, next to the Hovezeh Cinema, University avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.MUMS.REC.1397.047

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organs

2

Description of health condition studied
Cancer
ICD-10 code
C30-C39
ICD-10 code description
Malignant neoplasms of respiratory and intrathoracic organs

3

Description of health condition studied
Cancer
ICD-10 code
(C40-C41)
ICD-10 code description
Malignant neoplasms of bone and articular cartilage

4

Description of health condition studied
Cancer
ICD-10 code
(C43-C44)
ICD-10 code description
Melanoma and other malignant neoplasms of skin

5

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

6

Description of health condition studied
Cancer
ICD-10 code
(C69-C72)
ICD-10 code description
Malignant neoplasms of eye, brain and other parts of central nervous system

7

Description of health condition studied
Cancer
ICD-10 code
(C73-C75)
ICD-10 code description
Malignant neoplasms of thyroid and other endocrine glands

Primary outcomes

1

Description
Cancer Stigma
Timepoint
Before intervention, after intervention, 8 weeks after intervention
Method of measurement
Cancer Stigma Inventory

2

Description
Human Dignity
Timepoint
Before intervention, after intervention, 8 weeks after intervention
Method of measurement
Human dignity questionnaire

3

Description
Emotional Intelligence
Timepoint
Before intervention, after intervention, 8 weeks after intervention
Method of measurement
Emotional Intelligence Questionnaire

4

Description
Spiritual Intelligence
Timepoint
Before intervention, after intervention, 8 weeks after intervention
Method of measurement
Spiritual intelligence questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Emotional Intelligence Training
Category
Prevention

2

Description
Intervention group: Spiritual intelligence training
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Oncology Hospital of Mashhad
Full name of responsible person
Saeed Sarabian
Street address
Omid Hospital, Al-Dasht Crossroad, Kuhsangi Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Fax
+98 51 3842 8622
Email
omidhos@mums.ac.ir
Web page address
http://omid.mums.ac.ir/index.php

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University of Gonabad
Full name of responsible person
Kazam Golbaf
Street address
Payam Noor University of Gonabad Center, Ferdows Square, End of Shahid Shahrideh Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691964997
Phone
+98 51 5725 9210
Fax
+98 51 5725 9204
Email
Sarabians@pnum.ac.ir
Web page address
http://gonabad.razavi.pnu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor University of Gonabad
Proportion provided by this source
50
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
Payam Noor University of Gonabad
Full name of responsible person
Bibi Maryam Hashemi
Position
Student of Master of Islamic Psychology
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
Payam Noor University of Gonabad Center, Ferdows Square, End of Shahid Shahrideh Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9146875643
Phone
+98 903 701 7284
Email
hashemem96@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame Noor University of Gonabad
Full name of responsible person
Bibi Maryam Hashemi
Position
Student of Master of Islamic Psychology
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
Payam Noor University of Gonabad Center, Ferdows Square, End of Shahid Shahrideh Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9146875643
Phone
+98 903 701 7284
Email
hashemem96@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University of Gonabad
Full name of responsible person
Bibi Maryam Hashemi
Position
Student of Master of Islamic Psychology
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
Payam Noor University of Gonabad Center, Ferdows Square, End of Shahid Shahrideh Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9146875643
Phone
+98 903 701 7284
Email
hashemem96@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data documents will be shared in Thesis and article form.
When the data will become available and for how long
داده6 months after printing results
To whom data/document is available
Gonabad's Payam Noor University license will only be available to researchers working in academic institutions.
Under which criteria data/document could be used
Gonabad's Payam Noor University license will only be available to researchers working in academic institutions.
From where data/document is obtainable
Research Deputy of Payame Noor University of Gonabad
What processes are involved for a request to access data/document
To request documentation and data files, go to the Research Vice-President of Gonabad Noor University.
Comments
Loading...