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The Effectiveness of an Interventional-Supportive Program on Children's Anxiety and Pain Hospitalized in Surgery Department

Protocol summary

Study aim
Determining the Effect of an Interventional-Supportive Program on Hospitalized children's Anxiety and Pain
Design
Two-group clinical trial of non-random assignment
Settings and conduct
This research is a clinical trial that aims to investigate the impact of an interventional-supportive program on severity of pain and anxiety after pediatric surgery. Sampling is an easy-continuous type and 64 hospitalized and operated children, aged 3-6 years, are selected and placed in two groups of control and intervention. In the first stage, sampling is done in the control group. One day after the surgery, the severity of anxiety _using Piyeri tool_ and pain scale_using Toddler-Preschool-Post operative Scale(TPPPS)_ are measured by the researcher.This group is routinely cared and 1-2 hours later, the child's anxiety and pain are re-measured. Sampling continues till the number of samples in the control group is completed. In the intervention group, one day after the operation, the severity of child's anxiety and pain score are evaluated using the mentioned tools, and 1-2 hours after the implementation of the interventional-supportive program, the intensity of child's anxiety and pain score is re-evaluated using the above tools. .
Participants/Inclusion and exclusion criteria
Inclusion criteria: The age of 3 to 6 years, Having mental health and alertness, Having gastrointestinal Surgery, Non-entry criteria: Taking pain and anxiety-reducing medication, Having growth and mental retardation, Having previous surgical experience, Having a chronic illness (epilepsy, seizures, diabetes, known heart disease, kidney disease, Asthma).
Intervention groups
For the intervention group, the interventional-supportive program will be done based on the prepared booklet derived from educational concepts of kindergartens programs,and no intervention for the control group.
Main outcome variables
Pain and Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191004044976N1
Registration date: 2020-04-19, 1399/01/31
Registration timing: retrospective

Last update: 2020-04-19, 1399/01/31
Update count: 0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Sima Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 7821
Email address
simaaskari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of an Interventional-Supportive Program on Children's Anxiety and Pain Hospitalized in Surgery Department
Public title
The Effectiveness of an Interventional-Supportive Program on Children's Anxiety and Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
3 to 6 year old children Having mental health and consciousness Surgery on the gastrointestinal Children whose hospitalization is longer than two days after surgery
Exclusion criteria:
Taking anti anxiety drugs Having growth and mental retardation Having a history of chronic illness (epilepsy, seizures, diabetes, diagnosed heart disease, kidney disease) Previous surgical experience Taking anti pain drugs
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Not 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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Building No.4, Isfahan University of Medical Science, Hezarjirib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.401

Health conditions studied

1

Description of health condition studied
Pediatric surgery ‎
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, One hour After intervention.
Method of measurement
Toddler-Preschool-Post operative scale(TPPPS)

2

Description
Anxiety
Timepoint
Before intervention, One hour After intervention.
Method of measurement
Piyeri's Self-report tool for severity of anxiety.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: One day after the surgery,first the child's pain is assessed by Toddler-Preschool-Post operative scale and the child's anxiety is assessed using self-report Piyeri tool by the researcher. Then, while creating peace in an intimate atmosphere and maintaining proper communication from person to person based on the child's mood, age, gender, developmental, emotional, psychological and social needs, using the designed booklet, the counseling-supportive intervention will be done for about 45 minutes. This intervention uses distraction methods, such as expressing emotions, storytelling, playing game, and the joy of to doing handiwork.This booklet has been developed according to the needs of children and educational goals for kindergartens and preschool ages and has benefits such as transferring experience and teaching life skills to children, developing self-confidence and increasing problem-solving skills, creativity and familiarity with mathematical concept.1-2 hours after the intervention ,using the mentioned tools,the child's pain and anxiety is re-measured.
Category
Treatment - Other

2

Description
Control group: One day after the surgery, first the child's pain is assessed by Toddler-Preschool-Post operative scale and then the child's anxiety is assessed using self-report Piyeri tool by the researcher. For this group, only routine care is provided. 1-2 hours later, the child's anxiety and pain are re-measured. This process continues till the samples are completed in the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein Pediatric Hospital
Full name of responsible person
Mehrdad Memarzadeh
Street address
Isfahan - km 10 Street Imam Khomeini - hospital Imam Hussein
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
Emamhossein_hospital@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Isfahan University Of Medical Sciences
Street address
Building No.4, Isfahan University of Medical Science, Hezarjirib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
nrec@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Askari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 16, Jafar Hadi Alley, Behdarilashkar Strt, Artesh Strt
City
Isfahan
Province
Isfehan
Postal code
8174764181
Phone
+98 31 3627 7821
Email
simaaskari@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Askari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 16, Jafar Hadi Alley, Behdarilashkar Strt, Artesh Strt
City
Isfahan
Province
Isfehan
Postal code
8174764181
Phone
009831326277821
Email
Simaaskari@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Askari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 16, Jafar Hadi Alley, Behdarilashkar Strt, Artesh Strt
City
Isfahan
Province
Isfehan
Postal code
8174764181
Phone
+98 31 3627 7821
Email
Simaaskari@nm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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