The effect of self-management of pain with self-care on nature of pain and quality of life in patients with sickle cell disease
Design
The clinical trial study has a control group with three groups of pain and control self-care-self-management groups. Samples are three groups of 25 people randomly grouped using random number table.
Settings and conduct
The study was performed at Shahid Baqai Hospital in Ahvaz and Shahid Beheshti Hospital in Abadan. Random sampling, then self-care training for patients in the first group, self-management of pain in the second and third groups are also observed. Questionnaires will be completed before and after the intervention.
Participants/Inclusion and exclusion criteria
Entry Criteria: Be willing to participate in the study. - Be able to read and write. Be in the age range of 18-65 years.
Criteria for non-entry: non-cooperation of the patient to continue participating in the study (two consecutive or intermittent absenteeism sessions) - concurrent complications of other chronic diseases - any acute mental disorder and acute physical illness
Intervention groups
Group 1: Teaching self-care techniques to self-care group.
Group 2: Teaching pain management techniques to the pain management group.
Group 3: The group with no training.
Main outcome variables
quality of life of sickle cell patients, pain of sickle cell patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160726029086N5
Registration date:2020-04-15, 1399/01/27
Registration timing:retrospective
Last update:2020-04-15, 1399/01/27
Update count:0
Registration date
2020-04-15, 1399/01/27
Registrant information
Name
Nasrin Elahi
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8071
Email address
elahi-n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2019-10-09, 1398/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management of pain with self-care on nature of pain and quality of life in patients with sickle cell disease
Public title
effect of pain management with self-care on pain and quality of life in patients with sickle cell disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Be able to communicate in the context of transferring experiences
Aged 18 years and up
Exclusion criteria:
Concurrent with complications from other chronic diseases
Affected by any acute mental disorder and acute physical illness
Age
From 18 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
Allocation of individuals to each study group is done using a random number table and a simple random method. The number zero was removed from the table of random numbers, and the numbers 1, 2, and 3 were considered for the self-care group, the numbers 4, 5, and 6 for the pain self-management group, and the numbers 7, 8, and 9 for the control group.
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 ahvaz university of medical sciences
Street address
College Of Nursing, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.AJUMS.REC.1398.017
Health conditions studied
1
Description of health condition studied
Sickle Cell Disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
Measurement of quality of life 1,2 and 3 months after intervention.
Method of measurement
Quality of life questionnaire for sickle cell patients
2
Description
The Nature of Pain
Timepoint
Measuring the nature of pain 1, 2 and 3 months after the intervention.
Method of measurement
McGill Pain Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The self-care group is a 25-person group that provides necessary education about self-care, such as nutrition, medication, and so on. Pain and quality of life questionnaires were administered to patients after intervention. In the self-care group, patients will be divided into 5-person groups and will be taught in 4 sessions, basic information about the disease, how to use the medication, physical activity, pain exacerbations and ...... The method of training will be like a pain management group.
Category
Lifestyle
2
Description
Intervention group 2: The self-management group consisted of 25 patients who were trained on pharmacological and non-pharmacological methods of pain reduction and quality of life questionnaire and McGill pain questionnaire before and after the intervention. The pain self-management program will be administered over 4 sessions for 12 weeks in which patients will be divided into 5 groups. After the intervention phase, patients will be followed up in individual weeks, in-person follow-up, and in paired follow-up weeks. At the end of the training session, one, two, and three months after the training, the questionnaires will be completed by the sample units. The process of group training is as follows.
Category
Lifestyle
3
Description
Control group: There are 25 people in the group with no intervention. But at the end of the study they will be given the necessary training in groups one and two.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Baqaei Hospital of Ahvaz
Full name of responsible person
seyyedeh azadeh moosapour
Street address
College Of Nursing، Golestan Highway، Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 4377 4244
Email
samoosapour@gmail.com
2
Recruitment center
Name of recruitment center
Abadan Shahid Beheshti Hospital
Full name of responsible person
Seyyedeh Azadeh Moosapour
Street address
Ahmad abad Avenue-Shahid Beheshti Hospital
City
Abadan
Province
Khouzestan
Postal code
6316648371
Phone
+98 61 4377 4244
Email
samoosapour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badvi
Street address
Ground Floor, Vice Chancellor for Research and Technology of Ahvaz University of Medical Sciences, Shahr Daneshghahi
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 4372 4244
Email
samoosapour@gmail.com
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
Seyyedeh Azadeh Moosapour
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
College Of Nursing، Golestan Highway، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 4377 4244
Email
samoosapour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyyedeh Azadeh Moosapour
Position
کارشناسی ارشد
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
College Of Nursing، Golestan Highway، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 4377 4244
Email
samoosapour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyyedeh Azadeh Moosapour
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
College Of Nursing، Golestan Highway، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 4377 4244
Email
samoosapour@gmail.com
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