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Effect of Non-Drug palliative care on quality of life in patients with Chronic Obstructive Pulmonary Disease

Protocol summary

Study aim
The Study of the effect of Non-Drug palliative care on quality of life in patients with Chronic Obstructive Pulmonary Disease in hospitals of Yazd university of medical sciences in 2018.
Design
A clinical trial, the research community is chronic obstructive pulmonary disease patients referring to the in hospitals of Yazd University of Medical Sciences in 2018. the research sample is 60 patients who are divided in to control and intervention groups patients in intervention group on pairs and control group on days.
Settings and conduct
The researcher is referring to the in hospitals of Yazd University of Medical Sciences. Available samples are selected according to inclusion and exclusion criteria, and they are randomly assigned to two groups. Then, the questionnaires are completed before and after intervention in all two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 40 years, History of chronic pulmonary disease, Patients are from Yazd, Admission for at least six days, Ability to communication. Exclusion criteria: History of other chronic disease, Failure to perform interventions taught to patients, Speech and Hearing Problems, Crisis conditions such as asthma and physical- psychological disability, History of mental illness, Failure to complete the questionnaire.
Intervention groups
Patients are divided in to intervention and control groups, 1- Intervention group: Training and implementation of Non-drug palliative care. 2- Control group: Receive routine nursing care.
Main outcome variables
The effect of Non- drug palliative care, Quality of life in patients with chronic pulmonary obstructive.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160914029817N6
Registration date: 2018-06-15, 1397/03/25
Registration timing: registered_while_recruiting

Last update: 2018-06-15, 1397/03/25
Update count: 0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Esmat Nuhi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
e_nuhi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-15, 1397/03/25
Expected recruitment end date
2018-08-16, 1397/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Non-Drug palliative care on quality of life in patients with Chronic Obstructive Pulmonary Disease
Public title
Effect of Non-Drug palliative care on quality of life in patients with Chronic Obstructive Pulmonary Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40 years old History of chronic pulmonary disease Patients are from Yazd Admission for at least 6 days Ability to communicate
Exclusion criteria:
History of other chronic disease Failure to perform interventions taught to patients Speech and Hearing Problems Crisis conditions and such as asthma and physical-psychological disability History of mental illness and taking psychological drugs Failure to complete the questionnaire
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Ethical committee of kerman University of Medical Sciences
Street address
Kerman, the beginning of the Compus University of Medical Sciences, beginning around Seven Gardens Alavi, kerman Boulevard Haft Bagh Alavi, Medical Sciences Campus Kerman
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.KMU.REC.1397.072

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.9
ICD-10 code description
Other specified Chronic Obstructive Pulmonary Disease

Primary outcomes

1

Description
Quality of life
Timepoint
En Before intervention and after intervention
Method of measurement
Quality of life questionnaire SF-12

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: Patients receiving (COPD) in the intervention group receive palliative care using the training and implementation of the protocol. from the time of admission and admission time during 4 sessions, and the time of discharge and fallow up for one month after discharge, using a quality of life sf-12 Questionnaire and a self-report checklist. Training sessions included: First day: giving pamphlets and training on smoking cessation methods and diet, two day: Teaching effective breathing techniques, Day three: Lung physiotherapy, Day four: cold steaming
Category
Behavior

2

Description
Control group: The control group receives routine nursing care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Shahid sadoughi haspital
Full name of responsible person
Monireh Mashhadi
Street address
Yazd- safaeiye, Shahid Ghandi Blvd, Ibn sina Street
City
Yazd
Province
Yazd
Postal code
111111
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
Sadoghi-hospital@ssu.ac.ir
Web page address
http://ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhty
Street address
کرمان، چهارراه طهماسب آباد، ابتدای خیابان ابن سینا ، معاونت تحقیقات و فن آوری دانشگاه - مدیریت پژوهشی
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Web page address
http://vcrt.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Kerman University of Medical Sciences
Position
Master of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus University of Medical Sciences, beginning around Seven Gardens Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
mashgadi.m67@gmail.com
Web page address
http://kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Esmat Nouhi
Position
Associate professorََ
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Campus University of Medical Sciences beginning around Seven Gardens Alavi;Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Fax
+98 34 3132 5218
Email
e_nuhi@kmu.ac.ir
Web page address
htpp://kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kerman University of Medical Sciences
Position
Master of Medical Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus University of Medical Sciences, beginning around Seven Gardens Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3246 3507
Fax
+98 34 3132 5219
Email
mashhadi.m67@gmail.com
Web page address
http://kmu.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
Failure to complete the plan
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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