The aim of this study is evaluation of the effect of preoperative education on postoperative pain and anxiety in patients undergoing Percutaneous NephroLithotomy (PCNL). This study is single blinded randomized clinical trial, included 130 patients which randomly divide into 65 patients in case and control group (outcome assessors blinded). The inclusion criteria are age more than 15 year old, being mentally oriented to the situation, no addiction to narcotics or strong analgesics, no previous psychological disease, no severe pain due to underlying disease, no emergency condition and sign the consent form. The exclusion criteria are the patients who are not able to fulfill the questionnaire, simultaneous intervention and unusual complications such as perforation of the bowels which aggravates the pain. The case group will get extra information about the surgery and renal stones, by using pamphlets and face to face education while the control group didn’t get this extra information and only basic information will deliver to them. Primary outcome measure will be postoperative pain and anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011427135N3
Registration date:2017-02-10, 1395/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Saeide Bahrani
Name of organization / entity
Isfahn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 435 0474
Email address
isrc_info@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of preoperative education on postoperative pain in patient undergoing Percutaneus Nephrolithotomy (PCNL)
Public title
Evaluation the effect of preoperative education on postoperative pain and anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria are: age more than 15 year old; being mentally oriented to the situation; no addiction to narcotics or strong analgesics; no previous psychological disease; no severe pain due to underlying disease; no emergency condition and sign the consent form.
The exclusion criteria are: the patients who are not able to fulfill the questionnaire; simultaneous intervention and unusual complications such as perforation of the bowels which aggravates the pain.
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib st, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2013-05-14, 1392/02/24
Ethics committee reference number
191093
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Anxiety
Timepoint
Once after surgery
Method of measurement
Beck Anxiety Inventory
2
Description
Pain
Timepoint
After surgery, every 3 hours until discharge
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group received specific information both verbally and in a leaflet. The information content was about, what happens before surgery, who they would meet during the day (nurses, anesthetist, and so on) and some basic scientific information included introduction to urinary ducts, etiology of kidney stones and their types, Kidney stones sign and symptoms, diagnostic methods, preventive methods, brief explanation about PCNL and frequently asked questions of that.
Category
Other
2
Description
control group: control group did not receive the mentioned information.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
Alzahra hospital, Sofeh st, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Miss Pahlavan
Street address
Isfahan University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Sayed Ali Emami
Position
General Practitioner
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Postal code
Phone
+98 913 304 2736
Fax
Email
Ali.emami91@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sayed Ali Emami
Position
General Practitionar
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Postal code
Phone
+98 913 304 2736
Fax
Email
Ali.emami91@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sayed Ali Emami
Position
General Practionar
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Postal code
Phone
+98 913 304 2736
Fax
Email
Ali.emami91@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)