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The effect of comprehensive caring program on health outcomes of patients with general abdominal surgery in Zanjan.1389

Protocol summary

Summary
In this clinical trial, 118 patients (15-65 years) without chronic and disabling diseases that undergoing abdominal surgery in Zanjan Mousavi hospital will be randomly assigned in two groups. During hospitalization, the control group (59 cases) will receive routine program care and intervention group (59 cases), Will receive a plan of care including: physical, psychological and educational care. Intervention time is preoperative education for patients, 4-6 hours after surgery and the second morning after surgery on nursing process and time of hospital discharge, by education booklet. The health outcome of patients, including: pain, anxiety, nurse – patient communication, satisfaction, non-routine visit after discharge, and postoperative complications is one week after discharge will be evaluated .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103105987N3
Registration date: 2011-06-18, 1390/03/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-18, 1390/03/28
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
research deputy and educational of tehran university medical science
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of comprehensive caring program on health outcomes of patients with general abdominal surgery in Zanjan.1389
Public title
The effect of comprehensive caring program on health outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All patients that hospitalization at least 4 hours before abdominal surgery in emergency or surgery ward; age between15 to65 years old; absence of chronic and disabling diseases; not have been immune deficient and case for cancer or use of immunosuppressive drugs and 18.5<BMI <30 Exclusion criteria: Patient who dies or refers to ICU; re-admission due to surgical techniques complications and hospitalization more than 10 days and less than 48 hours
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 118
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Use of Watson theory

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics commitee of tehran university medical science
Street address
6th floor, university of central organization,Ghods Ave,St Bolvar Keshavarze
City
tehran
Postal code
Approval date
2010-07-06, 1389/04/15
Ethics committee reference number
89ص130/805

Health conditions studied

1

Description of health condition studied
General abdominal surgery
ICD-10 code
Z09.0
ICD-10 code description
Follow-up examination after surgery for other conditions

Primary outcomes

1

Description
Pain
Timepoint
6-4 hours after surgery, discharge day and 1 week after discharge
Method of measurement
Visual Analogue Scale

2

Description
Anxiety
Timepoint
Before intervention and on discharge day and 1 week after discharge
Method of measurement
VAS(visual analogue scale)

3

Description
Satisfaction
Timepoint
1 week after discharge
Method of measurement
Self- made questionnaire

Secondary outcomes

1

Description
Complication after surgery
Timepoint
1 week after surgery
Method of measurement
Study check list

2

Description
Unplanned medical visits
Timepoint
1 week after surgery
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: receives comprehensive caring program consist spiritual, mental and educational care and information booklet at discharge day
Category
Other

2

Description
Control group: receives standard hospital care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mousavi Hospital, Surgery ward
Full name of responsible person
Liela Alizadeh, nursing graduate student
Street address
Mousavi Hospital, Gavazang way
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masod Yonesian
Street address
6th floor, Central Building, Ghods Ave., Keshavarz Bolevard
City
Tehran
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, Tehran 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
Tehran University of Medical Scienses
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of nursing & midwifery ,Tohid Square
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
+98 21 6690 4252
Email
shghiyas@tums.ac.ir; shghiyas@yahoo.com
Web page address
www.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of nursing & midwifery,Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
+98 21 6690 4252
Email
shghiayas@tums.ac.ir; shghiyas@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of nursing & midwifery, tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
+98 21 6690 4252
Email
shghiyas@tums.ac.ir; shghiyas@yahoo.com
Web page address
www.tums.ac.ir

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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