Comparison the effect of receiving and not receiving self-care education on the function and quality of respiration in patients with chronic obstructive pulmonary disease
Comparison the effect of receiving and not receiving self-care education on the function and quality of respiration in patients with chronic obstructive pulmonary disease
Design
A clinical trial has two parallel groups of control and intervention, with a sample size of 70. The allocation of samples to the groups will be randomly using the random numbers table.
Settings and conduct
After receiving written permission from the Research and Technology Department and the Ethics Committee of Zahedan University of Medical Sciences, patients are enrolled according to inclusion criteria. They are randomly assigned to control and intervention groups. And their quality and respiratory function are measured , subsequently they receive the necessary training based on need.They are followed for 45 days and their quality and respiratory function are re-measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 40-65 years, Ability to read and write, History of hospitalization, Residence in Zahedan City, Not having formal education about chronic obstructive pulmonary disease, Satisfaction to participate in the study, Possibility to make a phone call, Known Case Of Chronic Obstructive Pulmonary Disease.
Non inclusion criteria: psychological and cognitive disorders, vision and hearing impairment that makes communication with the patient impossible, education in medical and para-medicine groups, drug addiction
Intervention groups
In the intervention group, 8 sessions and in control group one session about chronic obstructive pulmonary disease and complications will be held.
Main outcome variables
Respiratory function; respiratory quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181028041484N1
Registration date:2019-07-19, 1398/04/28
Registration timing:retrospective
Last update:2019-07-19, 1398/04/28
Update count:0
Registration date
2019-07-19, 1398/04/28
Registrant information
Name
Aliakbar Keykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
aliakbar.keykha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-05, 1397/07/13
Expected recruitment end date
2019-04-03, 1398/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of receiving and not receiving self-care education on the function and quality of respiration in patients with chronic obstructive pulmonary disease
Public title
The effect of self-care education on the quality and Function of Respiration
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age Between 40-65 years old
Ability to read and write
A previous history of chronic obstructive pulmonary disease hospitalization
Living in Zahedan
Consent to participate in the study
Have telephone access to patients
A known case of chronic obstructive pulmonary disease
Exclusion criteria:
formal education about chronic obstructive pulmonary disease
Cognitive and psychological diseases
Hearing and vision disturbances
Medical and paramedical professions
Age
From 40 years old to 64 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
Sampling method with convenience sampling is done and for the randomization of patients in the intervention and control groups, the first patient is selected using drawing numbers and allocated into one of the groups. Then patients will alternately be allocated into the intervention and control groups.
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 Zahedan University of Medical Sciences
Street address
Hesabi square, Zahedan university and medical science
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
78591-71155
Approval date
2018-10-05, 1397/07/13
Ethics committee reference number
IR.ZAUMS.REC.1397.259
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Forced expiratory volume in first second(FEV1),Forced vital capacity(FVC)
Timepoint
At the beginning of the patient's entry to the study and 45 days after end of the study
Method of measurement
Respiratory volumes are measured by spirometers.
Secondary outcomes
1
Description
Quality of respiration
Timepoint
45 days after the end of the intervention
Method of measurement
Quality of respiration measured by Saint George Respiratory Questionnaire
Intervention groups
1
Description
Intervention group:in the intervention group at baseline, Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) are measured by spirometers and quality of respiration is measured by St. George's breathing questionnaire,Then based on the educational needs of each patient, Face-to-face training in relation to deep breathing, diaphragmatic breathing, puffy breathing, proper diets, Using proper from respiratory inhaler sprays and medications, oxygen therapy, prevention of infection and avoidance of environmental stimuli are done. Training sessions are 8 that will be held during four weeks (two days in each week). Saturday and Tuesday, started at 10 am and continue for 30 minutes. Educational content is provided as a manual booklet for study at home. Patients spend 45 days on the educational program. After this period, respiratory volume is measured by spirometry and quality of respiration is measured by St. George's Respiratory Quality Questionnaire.
Category
Treatment - Devices
2
Description
Control group: In this group, only one training session is conducted on brief introduction to the disease and its complications, And the usual process of treatment without intervention is done. After 45 days, respiratory volume is measured by spirometry and quality respiration is measured with the St. George's Respiratory Quality Questionnaire. At the end of the study the training manual booklet prepared for the intervention group also will be given to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abitaleb Hospital (Zahedan)
Full name of responsible person
Aliakbar Keykha
Street address
Ali ibn Abitaleb Hospital, KHalige Fars Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
aliakbar.keykha@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
aliakbar keykha
Street address
mashahir square,college of nursing and midwifery
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
78591-71155
Phone
+98 34 4248 5032
Email
aliakhbar.keykha@zaums.ac.ir
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
aliakbar Keykha
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashahir square, College of nursing and midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
78591-71155
Phone
+98 34 4248 5032
Email
aliakhbar.kheykha@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Akbar Keykha
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashahir Square, School of Nursing and Midwifey, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
78591-71155
Phone
+98 34 4248 5032
Email
aliakhbar.kheykha@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
aliakbar keykha
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashahir Square, School of Nursing and Midwifey, Zahedan University of Medical Sciences
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
78591-71155
Phone
+98 34 4248 5032
Email
aliakhbar.kheykha@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
One of the ethical principles is the confidentiality of personal information.