Assessing the effect of family-oriented educational intervention on post-operative pain in patients undergoing orthopedic surgery (upper or lower limb)
This study aims to investigate the effect of family-oriented educational intervention on post-operative pain after orthopedic surgery (upper or lower limbs).In this quasi-experimental clinical trial study (with control group), the study population will be patients undergoing orthopedic surgery hospitalized in Ayatollah Mousavi medical educational center affiliated by Zanjan University of Medical Sciences. In this regard, 50 patients undergoing orthopedic surgery will be included in this study through using convenience sampling method. The experimental group (n = 25) and the control group (n = 25), will receive designed intervention and routine care respectively. The designed intervention will be consisted of educating the patient and the family members about theoretical aspects of post-operative pain, introducing non-pharmacological pain management procedures, encouraging patients and family members to express fears and beliefs about the side- effects of sedative drugs and telling patients how to use the visual analog scale (VAS) to assess pain before requesting sedative drugs. In order to assess the effect of designed intervention, visual analog scale (VAS) will be applied to assess the severity of post-operative pain up to three days after surgery. Inclusion criteria of this study are undergoing elective orthopedic surgery; being older than 18 years; having a healthy mental state; no history of drug abuse; and being accompanied by a family member during hospitalization. The study exclusion criteria will be lack of patients and their family’s cooperation during the intervention; decreased level of patient's consciousness after surgery; patient discharge or patient death; drug abuse in post-operative time and transferring the patients to another hospital. The post-operative pain is the main outcome of this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102816843N3
Registration date:2017-06-10, 1396/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-10, 1396/03/20
Registrant information
Name
Nasrin Bahraminejad
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8325
Email address
bahrami_n@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Zanjan University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of family-oriented educational intervention on post-operative pain in patients undergoing orthopedic surgery (upper or lower limb)
Public title
The effect of family educational on post operative pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Undergoing orthopedic surgery (upper or lower limbs); being older than 18 years; desire to participate in the study; ability to speak and read in Persian; healthy mental status; healthy visual status to see and understand VAS tool; being accompanied by a family member during hospitalization period. Exclusion criteria: history of previous surgeries; history of mental illnesses; using psychotropic drugs; history of drug abuse.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
quasi-experimental double blind clinical trial study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd
City
Zanjan
Postal code
Approval date
2015-06-07, 1394/03/17
Ethics committee reference number
ZUMS.REC.1394.317
2
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd
City
Zanjan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
00982433420670
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Post operative pain
Timepoint
Every one hour during the waking time, for 2-3 days after surgery
Method of measurement
VAS (Visual analog Scale)
Secondary outcomes
1
Description
Anexity
Timepoint
Before intervention and after second educational session
Method of measurement
Spielberger tool
Intervention groups
1
Description
Intervention group: Two face to face educational sessions with participation of family members, patients and nurses will be held. The first educational session will be conducted before and during surgery including educating the patients and a member of the family about post-operative pain physiology, non- pharmacological pain control intervention and pain assessment tools; Informing patients and family members on how to participate in post-operative pain management and evaluating the non- pharmacological pain control strategies effect, employed by patients in post -operative period. The second training session will be conducted after the surgery when the patients will regain consciousness, and during this session the following interventions will be done: Assessing, strengthening and encouraging the non-pharmacological strategies used by the patient
Category
Behavior
2
Description
Control group: Control group will receive routine care and pain will be merely assessed for 3 days after the surgery similar to intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and treatment center of Ayatollah Mousavi
Full name of responsible person
Monireh Rahmani
Street address
Educational and treatment center of Ayatollah Mousavi, Gavazang road
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Zanjan University of Medical Sciences
Full name of responsible person
Dr Vakili
Street address
Zanjan University of Medical Sciences, Azadi square
City
Zanjan
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, Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Monireh Rahmani
Position
MS student in critical care nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Mahdavi Blvd, Karmandan settlement
City
Zanjan
Postal code
Iran
Phone
+98 24 3341 8355
Fax
+98 24 3314 8319
Email
monirerahmani90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nasrin Bahraminejad
Position
Ph.D
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mahdavi Bllvd, Karmandan settlement
City
Zanjan
Postal code
Phone
+98 24 3314 8325
Fax
+98 24 3314 8319
Email
bahrami_n@zums.ac.ir
Web page address
http://www.zums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nasrin Bahrami nejad
Position
Ph.D
Other areas of specialty/work
Street address
ّ Faculty of Nursing and Midwifery ,Mahdavi Blvd, Karmandan settlement
City
Zanjan
Postal code
Phone
+98 24 3314 8325
Fax
+98 24 3314 8319
Email
bahrami_n@zums.ac.ir
Web page address
http://www.zums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)