Main outcome: To determine the impact of patient - controlled analgesia on patient's satisfaction after coronary artery bypass surgery
Objectives:
- to compare patient's satisfaction with patient controlled analgesia method in two groups
- To determine the correlation between demographic data with patient's satisfaction of pain control
- to determine nurses opinions about patient controlled analgesia method
- to determine pain severity in two groups
- to determine level of sedation in two groups
After approving the design and confirming the Questionnaire with the ethical considerations, we will take the permission of Research Deputy of Nursing Faculty. After coordination with hospital And ICU, the researcher will present the study goals; take the patients consents and their willing to participation in study. Then they will receive explanations about pain control satisfaction questionnaire a day before surgery.
Participants including major eligibility criteria: patients with coronary artery bypass surgery
Design: In a randomized control trail, with convenience sampling, patients after Coronary Artery Bypass Surgery in ICU of Shahid Rajaie Heart Center of Tehran, will randomly allocated to two groups.
Intervention: The interventional group, to be trained using Patient Control Analgesia (PCA). (In this method the physician determines the type and parameters of analgesia doses and patient just have control on injection pump and when he needs to analgesia, pushes the pump so the set adjusted based on physician order and patient cannot receive more than ordered parameters). In control group the pain will control by the nurse (Nurse Control Analgesia) as usual. Sample size will determine after pilot study.
Setting and conduct: During two days the satisfaction of patients with the pain control will be asked by a blinded nurse, and she will fill in the Questionnaire. At the end, the satisfaction with the pain control in two groups will compare statistically by SPSS.
main outcome measures (variables):satisfaction of patients dependent variable and pain control method as independent variable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103195665N2
Registration date:2011-07-20, 1390/04/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-20, 1390/04/29
Registrant information
Name
Sima Lakdizaji
Name of organization / entity
Tabriz University of Medical Sciences, Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
laks@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Medical Science University, Vice chancellor for research , Nursing and Midwifery Faculty
Expected recruitment start date
2011-08-20, 1390/05/29
Expected recruitment end date
2012-01-16, 1390/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of patient - controlled analgesia on patient's satisfaction after coronary artery bypass surgery in Shahid Rajaei Heart center in 2011.
Public title
Impact of patient - controlled analgesia on patient's satisfaction after cardiac surgery in Shahid Rajaei Heart center in 2011.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age 30-60 years old; admission in cardiac surgery ICU for bypass surgery; consent for participation in research
Exclusion criteria: to have addiction; sensitivity for Morphine; not to be able for working with patient control anesthesia; renal diseases with creatine more than2; liver disease; to have re surgery for bleeding; psychological disease; unstable hemodynamic status with blood presser less than 90 mmHg, and receiving inotrope medications; low consciousness; ejection fraction less than %30;entrance to operating room by emergency; intubation more than 6 hours.
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
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
Tabriz Medical Science University, Vice chancellor for research, Ethics committee
Street address
Vice chancellor for research, Amoozesh Building, Tabriz Medical Science University, Daneshgah Ave, Tabriz
City
Tabriz
Postal code
Approval date
2011-04-25, 1390/02/05
Ethics committee reference number
1160/4/5
Health conditions studied
1
Description of health condition studied
pain control after heart surgery
ICD-10 code
197.8
ICD-10 code description
Other post procedural disorders of circulatory system, not elsewhere classified
Primary outcomes
1
Description
patient satisfaction of pain control
Timepoint
every 12 hours after heart surgery until 2 days after surgery
Method of measurement
Pain Treatment Satisfaction Scale
Secondary outcomes
1
Description
Nurses opinions about pain control method
Timepoint
every 12 hours after heart surgery until 2 days postsurgery
Method of measurement
by 6 questions about nurses opinions
2
Description
Pain Severity
Timepoint
Every 4 hours for 2 days after surgery
Method of measurement
Visual Analog Scale
3
Description
Sedation level
Timepoint
Every 4 hours for 2 days after surgery
Method of measurement
Sedation Scale
Intervention groups
1
Description
The interventional group, to be trained using Patient Control Analgesia (PCA=Patient Control Analgesia pump).In this method during two days post surgery, the physician determines the type and parameters of analgesia doses and the patient receives the base doses of analgesia by intravenous infusion, and he just have control on injection pump and when he needs to analgesia, pushes the PCA pump so the set adjusted based on physician order and patient demand, so he cannot receive more than ordered parameters ). So he can take analgesia before worsen his pain and when he needs more doses of analgesia.
Category
Treatment - Devices
2
Description
In control group the pain will control by the nurse (Nurse Control Analgesia) as usual and routine of unit, based on physician orders, during two days postoperatively.
During two days the satisfaction of patients in two groups with the pain control will be completed by a blinded nurse, and she will fill in the Pain Control Satisfaction Questionnaire.
At the end, the satisfaction with the pain control in two groups and pain severity scale will compare statistically by SPSS.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Shahid Rajaie Heart Center
Full name of responsible person
Atoosa Hosseinzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz Medical Science University, Vice chancellor for research, Dr. Mohamreza Rashidi
Full name of responsible person
Soheila Bani,
Street address
5138947-977, Nursing and Midwifery Faculty, Shriati Jnoobi Ave.Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Medical Science University, Vice chancellor for research, Dr. Mohamreza Rashidi
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
Tabriz Medical Science University
Full name of responsible person
Atoosa Hosseinzade
Position
Ms. student in Medical Surgical Nursing, Operating Room Nurse
Other areas of specialty/work
Street address
5138947977, Nursing and Midwifery Faculty, Shariati Jnoobi Ave, Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 41 1477 0648
Fax
+98 41 1479 6969
Email
Atoosa.Hosseinzaeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Sima Lakdizaji
Position
Lecturer
Other areas of specialty/work
Street address
5138947977, Tabriz Nursing and Midwifery Faculty, Shariati Jnoobi Ave.
City
Tabriz
Postal code
5138947977
Phone
+98 41 1477 0648
Fax
+98 41 1479 6969
Email
laks@tbzmed.ac.ir; lak1369@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical Science University, Vice chancellor for research
Full name of responsible person
Sima Lakdizaji
Position
Lecturer/Ms
Other areas of specialty/work
Street address
5138947977, Nursing and Midwifery Faculty, Shariati Jnoobi Ave
City
Tabriz
Postal code
5138947977
Phone
+98 41 1477 0648
Fax
+98 41 1479 6969
Email
laks@tbzmed.ac.ir; lak1369@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)