Determining the effect of self-management training on pain intensity and quality of life in metastatic cancer patients
Design
A clinical trial with a control group, randomized
Settings and conduct
The intervention group uses 8 weeks of self-administered pain management techniques that are taught and recorded on the checklist. At first and 3 months later, quality of life is also measured. The control group does not receive the training. But the pamphlet Educational is given to both groups. This study is done in Oncology Clinic of Ahvaz Golestan Hospital.
Participants/Inclusion and exclusion criteria
Entry requirements:
1- The age of the patients is between 18 and 80 years
2- People whose score is based on scale of 10-3
Non-arrival condition:
1. Persons who are physically capable of managing self-management pain
2.People who can not communicate
Intervention groups
The intervention group uses 8 weeks of self-administered pain management techniques that are taught and recorded on the checklist. At first and 3 months later, quality of life is also measured. The control group does not receive the training. But the pamphlet Educational is given to both groups.
Main outcome variables
pain,
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190418043314N1
Registration date:2019-07-14, 1398/04/23
Registration timing:registered_while_recruiting
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Mahsa Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 4622
Email address
mousavi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Self-care education on the severity of pain and quality of life in patients with metastatic cancer
Public title
Investigating the effect of self-care in Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the Patients is between 18 and 80 years old
Individuals whose scores are based on a scale of 3-10
Persons who are physically capable of self-management
People who have the ability to communicate
People who have read and write literacy
People who have not had a history of using complementary therapies in the past and now
Exclusion criteria:
People who are physically unable to manage self-management
People who can not communicate
People who are not literate to read and write
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected based on entry criteria and then assigned randomly into intervention and control groups. The method of assigning intervention to individuals is randomized and random blocked blocks with block size 4 (using the table for random permutations). The randomization list is provided by a statistic specialist. The intervention used in this research according to a randomized list is provided by a person outside the study who is not aware of the research objectives and will be assigned a different code to the closed envelopes and will be allocated to any disease that is included in the study.
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 Ahvaz University of Medical Sciences
Street address
No.7,Shamkhani Ave., Azadegan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6193763331
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.AJUMS.REC.1397.606
Health conditions studied
1
Description of health condition studied
Metastatic cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Before intervention and every day for 8 weeks after intervention
Method of measurement
Visual Analogue Scale
2
Description
Quality of Life
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Questionnaire on 30 questions for assessing the quality of life of patients with cancer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the test group, after completing the questionnaires, patients received routine care, self-management training for pain (respiratory and respiratory compression, and visual therapy), and for 8 weeks, daily pain intensity and method used in the check The relevant list is recorded and after 3 months the quality of life is measured again.
Category
Rehabilitation
2
Description
Control group: In the control group, demographic questionnaires, needs assessment and quality of life and daily checklist were distributed and received routine care. At the end of the study, educational pamphlets were also distributed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Mahsa Mousavi
Street address
No.7,Shamkhani Ave.,Azadegan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6193763331
Phone
+98 61 3292 4622
Email
mousavi.m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr majid karandish
Street address
No.7,Shamkhani Ave.,Azadegan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6193763331
Phone
+98 61 3292 4622
Email
mousavi.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7.,Shamkhani Ave., Azadegan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6193763331
Phone
+98 61 3292 4622
Email
mousavi.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.7.Shamkhani Ave,Azadegan Blvd,Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6193763331
Phone
+98 61 3292 4622
Fax
Email
mousavi.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.7.Shamkhani Ave,Azadegan Blvd,Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6193763331
Phone
+98 61 3292 4622
Fax
Email
mousavi.m@ajums.ac.ir
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