Aim:The effect of face to face training in pain severity and anxiety in children with outpatient surgery 2-Plan: After getting permission from Dezful University of Medical Sciences and submitting it to the President of Dr. Ganjavian Hospital of Dezful and the Head of the Emergency Department,30,6 to 12year-old children who need outpatient surgery with local anesthesia in all parts except for their faces and those who have inclusion criteria have been selected within two months. 3-Method:The patients in this study have been divided into two intervening and control groups based on the date day (couple & single). Oral and written letters of satisfaction from parents will recive. 4-Inclusion criteria: patient’s consciousness; lack of mental and anxiety disorders; the avoidance of taking tranquilizers and painkillers before surgery. Exclusion criteria: the need for using tranquilizers and painkillers during and at the end of surgery; parents’ unwillingness to continue cooperating 5-Interventions: The method and principles of wound care have been described for the patients in the intervening group in a simple language. Moreover, the children have been informed that they can have a faster surgery if they cooperate. In both groups, it has been recommended that the parents accompany their children during the surgery. 6-Original variables:The anxiety and pain level of children was measured using Modified-Yale Preoperative Anxiety Scale (M-YPAS) and Faces Pain Scale–Revised (FPS-R)respectively in 3 stages: preoperative and pre-intervention (baseline), preoperative and post-intervention, and postoperative and post-intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020714930N4
Registration date:2016-04-17, 1395/01/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-17, 1395/01/29
Registrant information
Name
Marzieh Beigom Bigdeli Shamloo
Name of organization / entity
Dezful Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 61 4252 3912
Email address
m.bigdeli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dezful Medical Sciences University
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pre-operative face-to-face education on pain and anxiety of children with upper or lower extremities trauma undergoing outpatient surgery
Public title
The Effect of Education on severity of pain and anexity
Purpose
Supportive
Inclusion/Exclusion criteria
nclusion criteria:age between 6 and 12 years old, lack of any sign of bone fractures, dislocation, amputation, presence of a foreign body, nerve damage, fever as well as infection, not using cast or splint at trauma site, having full consciousness and being able to understand and follow instructions to complete pain and anxiety assessment scales, children being accompanied by their parents (either mother or father) on the day of admission, speaking Persian (both children and their parents being able to speak and read Persian), lack of using sedative or analgesic before the surgery, lack of developmental, physical or psychological problems, not having previous hospitalization, emergency department admission or surgery after 18 months of age, and lack of having a long-term illness and/or pain that requires special medical care.
Children who their parents disagreed to continue the study were excluded
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Etics Committe of Dezful Medical Sciences University
Street address
Dezful Medical Sciences University, the end of Azadegan Bol
City
Dezful
Postal code
Approval date
2016-02-01, 1394/11/12
Ethics committee reference number
IR.DUMS.REC.14
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
2
Description of health condition studied
anexity
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
pain
Timepoint
before,during and 1 hour after the end of surgery
Method of measurement
Faces Pain Scale–Revised (FPS-R)
Secondary outcomes
1
Description
anexity
Timepoint
before,during and 1 hour after the end of surgery
Method of measurement
Modified-Yale Preoperative Anxiety Scale (M-YPAS)
Intervention groups
1
Description
wound care have been described for the patients in the intervening group in a simple language.
Category
Other
2
Description
Control group: No training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Ganjavian Hospital
Full name of responsible person
Marzieh Beigom Bigdeli Shamloo
Street address
Dr Ganjavian Hospital, Dezful_ Andimeshk road
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Dezful Medical Sciences University
Full name of responsible person
Malihe Sohrabi Vafa
Street address
Dezfu lUniversity of Medical Sciences , the end of Azadegan Bol
City
Dezful
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 Dezful Medical Sciences University
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
Dezful Medicine Sciences University
Full name of responsible person
Marzieh Beigom Bigdeli Shamloo
Position
Mastery degree of education nursing
Other areas of specialty/work
Street address
Dr Ganjavian Hospital, Dezful_ Andimeshk road
City
Dezful
Postal code
Phone
+98 61 4242 3912
Fax
Email
m.bigdeli@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezful Medicine Sciences University
Full name of responsible person
Marzieh Beigom Bigdeli Shamloo
Position
Mastery of Critical Care Nursing
Other areas of specialty/work
Street address
Dr Ganjavian Hospital, Dezful_Andimeshk road
City
Dezful
Postal code
Phone
+98 61 4242 3912
Fax
Email
m.bigdeli@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dezful Medicine Sciences University
Full name of responsible person
Marzieh Bigom Bigdeli Shamloo
Position
Masery degree of education nursing
Other areas of specialty/work
Street address
Dr Ganjavian Hospital, Dezful_Andimeshk road
City
Dezful
Postal code
6461816193
Phone
+98 61 4242 3912
Fax
Email
m.bigdeli@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)