objectives: The aim of this study is comparison of a cardiac rehabilitation program on adjustment; body image and complication of patient with cardiac management rhythm device, Including permanent pacemaker(PM), cardiac resynchronization therapy devices (CRT) and implantable cardioverter defibrillator(ICD) at pace implantation clinic faqihi and ghalb zahra shiraze hospital sep 2014-sep 2015. Design: This study is a randomised clinical trial with control group. Setting and conduct: 100 patient with cardiac management rhythm device will be enrolled the survey. Patients will be divided into two groups randomly intervention(n=50) and control groups(n=50). Participants including major eligibility criteria: The major inclusion criteria is patients are age 18- 70 years and the first time implantation . The exclusion criteria are Lack of consent to continue participating in the study. Intervention: cardiac rehabilitation are used for the intervention group for a period of 2 months (24 Session). Control group receive routine medical care program. . Main outcome: The primery outcome are evaluation of complication ( researcher- made questionnaire) , adjustment (psychosocial adjustment to illness questionnaire) and body Image (body image questionnaire). Before, 8 and 12 week after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083118982N1
Registration date:2015-08-05, 1394/05/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-05, 1394/05/14
Registrant information
Name
Leila Ansarifard
Name of organization / entity
Square, Namazi, Shool of Nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 71 3872 7091
Email address
ansari_le@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-08-25, 1393/06/03
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of a cardiac rehabilitation program on adjustment; body Image and complication of patient with cardiac managment rhythm device.
Public title
Cardiac Managment Rhythm Devic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients are aged 18-70 years; are of both sex; For the first time device is implanted; Patients who have the ability to participate in the rehabilitation program; speech and hearing problems are not known ; physical mental disability which prevents the ability not participate in session. Exclusion criteria: patient's unwillingness to continue participating in the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patient occording number randomly table divided to intervention and controlls group.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of'' Shiraz University of Medical Sciences"
Street address
Zand, Street, Central Building Of
City
Shiraze
Postal code
71345,1978
Approval date
2014-08-24, 1393/06/02
Ethics committee reference number
CT7128,93
Health conditions studied
1
Description of health condition studied
pacemaker implantation
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Adjustment
Timepoint
Befor, 8 Week and 12 Week After Intervention
Method of measurement
Psycho-Social Adjustment Scale(PIAS))
2
Description
Bodyimage
Timepoint
Befor,8 Week and 12 Week After Intervention
Method of measurement
Bodyimage And Relationsheep Questionnaire
3
Description
Complication
Timepoint
Befor, 8 Week And 12 Week After Intervention
Method of measurement
Researcher Made Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For Pacemaker patient in experimental group(25), the Cardiac Rehadilitation Program(CR) consisted of a 3 sessions(8 Weeks, every tow weeks,100 min)including exercise training 40 min, education 30 min and psycho-educational intervention30 min.
Category
Rehabilitation
2
Description
For implantable cardioverter defibrillator and synchronized bivantriculare pacing patient in experimental group(25), the Cardiac Rehadilitation Program(CR) consisted of a 3 Sessions(8 Weeks, every tow weeks,100 min) including exercise training 40 min, education 30 min and psycho-educational intervention30 min.
Category
Treatment - Drugs
3
Description
For (50) patient in contorl group the routine intervention was done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghalb Zahra Hospital
Full name of responsible person
leila Ansarifard
Street address
Qaeem Hospital
City
Firoozabad
2
Recruitment center
Name of recruitment center
Faqihi Hospital (Pacemaker Clinic)
Full name of responsible person
leila Ansarifard
Street address
Qaeem Hospital
City
Firoozabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellore for research, Shiraze university of Midical Scienes
Full name of responsible person
Dr.Seed,Baser Hashemi
Street address
Zand,Street,Shiraze University of Medical Sciences Center"
City
Shiraz University of Medical Sciences
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellore for research, Shiraze university of Midical Scienes
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
School of Nursing and Midwifery, Namazi, Square
Full name of responsible person
Dr.Mahnaz Rakhshan
Position
School of Nursing and Midwifery,Assistant professar,Medical-surrjecal,MD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi, Square Shiraz University of Medical Sciences
City
Shiraze
Postal code
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
rakhshanm@sums.ac.i; rmzrakhshan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr.Mahnaz Rakhshan
Position
Assistant Professar
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi, Square Shiraz University of Medical Sciences
City
Shiraz University of Medical Sciences
Postal code
Phone
+98 71 3647 4254
Fax
Email
rakhshanm@sums.ac.ir; mzrakhshan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Namazi, Square
Full name of responsible person
leila Ansarifard
Position
msc Student in Critical.Care Nursing,Shiraz university of Medical Sciences
Other areas of specialty/work
Street address
Qaeem Haspital
City
Firoozabad
Postal code
Phone
+98 71 3872 7091
Fax
Email
ansari_le@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)