Protocol summary

Summary
Introduction and aims: Patients in intensive care units experience many physiological and psychological complications that their recovery sometimes takes several years. Life quality of intensive patients after discharge is lower than other internal and surgical patients and physical problems makes a person disable in doing daily activities. This study assesses the effect of using self-help rehabilitation program on the life quality of the patients discharged from Intensive Care Units. Methods: It was a clinical trial study which was done on ninety patients of internal-surgical intensive units of three hospitals in Kerman. This study was done by SIP68 life quality questionnaire with three physical, psychological and social areas and six dimensions in 2012. After patients’ discharged from intensive care unit, they were in a general ward in tow case and control groups, data were analyzed by using inferential, descriptive statistical tests and SPSS19 software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110197844N1
Registration date: 2014-06-11, 1393/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-11, 1393/03/21
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the impact of using a self help rehabilitation program on post ICU patient's health status in university hospitals of Kerman University of Medical Sciences.
Public title
Post intensive care unit patient's recovery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who stayed in ICU more than 48 hours; were mechanically ventilated ;were eager and able to participate in term of literacy and cognition state; Exclusion criteria: terminally ill patient ;patients with prolonged recovery like those with burn injury ;History of major psychological disorders as a confounding factor in psychological recovery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Ethics Committee of Vice chancellor for research, Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Postal code
7751123458
Approval date
2011-12-10, 1390/09/19
Ethics committee reference number
326/90/کا

Health conditions studied

1

Description of health condition studied
rehabilitation in intensive care survivors
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures

Primary outcomes

1

Description
Quality of life
Timepoint
Before and three months after intervention
Method of measurement
Sickness Impact Profile 68

Secondary outcomes

1

Description
demographic factors like age, gender, Length of stay and severity of illness score by APACHE ii
Timepoint
Before intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention Group: Intervention was an educational package that consist of weekly programmed manual, exercise training CD and three appointed telephone calls for follow up. This self-help manual guide patients to a better physical and mental situation step by step with a weekly plan. Every two week a phone call was done by researcher to evaluate patients' compliance with the program.patients were persuaded to use the program and probleme solving was done. The manual has three parts. First part is a plan table for exercise and activity of daily living that learn patients how to plan according to their his/ her abilities. Second parts is general recommedations about nutrition, relaxation, smoking abstenation, return to family and social life and so on. Third part is the grading exercising package and its guid for use that is usable with CDs. With appropriate patient's compliance and encourages of the researcher patients get ready within 6 weeks and would be reached an optimal level in term of physical and mental situation.
Category
Rehabilitation

2

Description
Control Group: This group did not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Three educational hospital of Kerman University of Medical
Full name of responsible person
Mansour Arab
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, kerman University of Medical Sciences
Full name of responsible person
Dr. Malekpour Afshar
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, kerman University of Medical Sciences
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
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7756341234
Phone
+98 34 1320 5179
Fax
Email
marab@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7754312345
Phone
+98 34 1320 5179
Fax
Email
marab@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
Phone
+98 34 1320 5179
Fax
Email
marab@kmu.ac.ir
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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