Protocol summary

Summary
This study examines the impact of motivational interviewing on self esteem and quality of life due to colon cancer patients who have undergone surgery and permanent ostomy . Inclusion criteria of having a permanent ostomy more than 6 months and less than 10 years. Has been created as a result of colon cancer . Methods This study is a randomized clinical trial of 70 patients with colon cancer test gives a permanent ostomy . 70 patients randomly assigned to intervention and control will be divided into two groups of 35 . Intervention group and 35 to 12 are divided into three groups: 12.11 . Then all three intervention groups separately under 2 hours will be 5 sessions of motivational interviewing . Before, 1 and 4 months post-intervention questionnaires, self concept and quality of life in ostomy patients will fill Shhrhp by both intervention and control groups . The results will be compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014040717161N1
Registration date: 2014-04-23, 1393/02/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-23, 1393/02/03
Registrant information
Name
Elham Rajabipour
Name of organization / entity
USWR
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
el.rajabipour@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Welfare and Rehabilitation Sciences
Expected recruitment start date
2014-04-14, 1393/01/25
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nursing intervention technique "motivational interviewing" group on quality of life and self-esteem of patients with colorectal cancer ostomy permanent
Public title
Ether group motivational interviewing and self-esteem and quality of life in patients with permanent ostomy
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria of having a permanent ostomy more than 6 months and less than ten years due to colon cancer, having minimum 18 and maximum 65 years of age, have a minimum qualification of Diploma Exclusion criteria: not wanting one, missed more than two sessions, team meetings
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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
University of Welfare and Rehabilitation Sciences
Street address
Tehran- evin- Student Blvd- koodakyar st-
City
Tehran
Postal code
1985713834
Approval date
2013-08-03, 1392/05/12
Ethics committee reference number
2/11641/ آ/92/801

Health conditions studied

1

Description of health condition studied
Gastrointestinal cancer
ICD-10 code
C26.9
ICD-10 code description
Ill-defined sites within the digestive system

Primary outcomes

1

Description
Quality of Life
Timepoint
Before - one and four months later
Method of measurement
Ostomy patients' quality of life questionnaire

2

Description
Self- esteem
Timepoint
Before - one and four months later
Method of measurement
Esteem Scale

Secondary outcomes

empty

Intervention groups

1

Description
Group A is comprised of eleven male participants in group therapy, motivational interviewing on Saturdays for 5 weeks, they leave behind.
Category
N/A

2

Description
Conducted five sessions of group motivational interviewing intervention groups. Each group will have five sessions.) Self-esteem and quality of life questionnaire before and 4 months after an intervention in both intervention and control groups Comparing the results obtained in the two groups
Category
N/A

3

Description
Group B consisted of 12 participants will be women who will pass on Monday 5 sessions of motivational counseling.
Category
N/A

4

Description
Group C consisted of six male and six female participants who will be attending on Wednesdays for five sessions of motivational counseling team will leave behind.
Category
N/A

5

Description
Society ostomy care than the control group who received no intervention will not receive. Intervals prior to the intervention group questionnaires, one month and four months for the control group filled out.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ostomy Association of Iran
Full name of responsible person
Dr. Anaraki
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr. ghaffarzadeh
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Welfare and Rehabilitation Sciences- Dr maddah
Full name of responsible person
Sadat Seyed Bagher Maddah
Street address
Tehran - Tehran's Evin Boulevard - Student - Yes Street -
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Welfare and Rehabilitation Sciences- Dr maddah
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
University of Welfare and Rehabilitation Sciences
Full name of responsible person
Elham Rajabipour
Position
Senior nursing student
Other areas of specialty/work
Street address
Kyanshhr Tehran - Iran standoff Imam Reza Ave Lorasib 4 - No. 12
City
Tehran
Postal code
Phone
+98 21 3361 1097
Fax
Email
el.rajabipour@uswr.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Welfare and Rehabilitation Sciences
Full name of responsible person
Elham Rajabipour
Position
Senior nursing student
Other areas of specialty/work
Street address
Kyanshhr Tehran - Iran standoff Lorasib Imam Reza Street 4 - No.12
City
Tehran
Postal code
Phone
+98 21 3361 1097
Fax
Email
el.rajabipour@uswr.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Welfare and Rehabilitation Sciences
Full name of responsible person
ElhamRajabipour
Position
Senior nursing student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
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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