Protocol summary

Study aim
Determining the effect of interactive playing on the intensity of anxiety before orthopedic surgery in children 4 - 6 year
Design
The third phase of the clinical trial with a control group with a parallel group design, which will be conducted with a sample size of 60 people (30 subject in each of the intervention and control groups) and with a gender block.
Settings and conduct
This study is carried out by implementing an interactive playing scenario designed by the research team on children with non-dominant lower or upper extremity closed fractures of 4-6 years old children at the time of entering the operating room corridor of Shafa yahyaian Hospital and in the presence of the child's mother. The control group will not receive any intervention.
Participants/Inclusion and exclusion criteria
Consent of the child's mother for the child's participation in the research ,Child's cooperation to study , The presence of the mother next to the child at the time of sampling, Child Age between 4 and 6 years, Absence of mental and cognitive developmental disorders , Not having hyperactivity or autism, No record of entering the operating room for any reason, No history of previous surgery, Closed fracture in any of the lower limbs or non-dominant upper limbs of the child , Non-elective type of surgery
Intervention groups
The intervention includes the use of gloves which filled by water and a magic marker that is given to the child to draw simple shapes such as eyes or eyebrows on each finger of the glove at certain times of the scenario, following the narration of the scenario designed by the research team. The control group will not receive any intervention.
Main outcome variables
Anxiety

General information

Reason for update
Acronym
---
IRCT registration information
IRCT registration number: IRCT20140721018550N11
Registration date: 2023-01-18, 1401/10/28
Registration timing: prospective

Last update: 2023-01-18, 1401/10/28
Update count: 0
Registration date
2023-01-18, 1401/10/28
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of interactive playing on the intensity of anxiety before orthopedic surgery in children 4 - 6 year
Public title
Effect of interactive playing on the anxiety before orthopedic surgery in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of the mother next to the child at the time of sampling No history of entering the operating room for any reason Closed fracture in any of the lower limbs or non-dominant upper limbs of the child Absence of mental and cognitive developmental disorders Not suffering from hyperactivity disorder or autism Pain score less than 6 according to the Wong Baker scale
Exclusion criteria:
Lack of cooperation Inability to continue intervention for any reason
Age
From 4 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
We use convenience sampling, but the samples will be allocated to intervention and control groups in the form of random blocks of four using the sealed envelope site. To ensure matching between the two groups as well as to achieve a completely random and balanced assignment, we will use a randomized classification using Stratified permuted block randomization. Individuals are then divided into two stratum of male and female, and for each class a separate random assignment is continued until the sample size is reached. For random assignment in each class based on different sequences of two methods A (intervention) and B (control), 4 blocks are defined and numbered from left to right from 1 to 4. Then using 1 to 4 random blocks of blocks are randomly selected. Thus, the assignment type is determined from left to right, respectively. Since we need 30 subject in each group, we have to randomly select the block 8 times for that class).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this research, for the interactive playing, we will use the scenario designed by the research team, which uses a glove filled with water, the story is told by the researcher, and the child paints the items on each finger of the glove with a magic marker.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Semnan University of Medical sciences
Street address
Basij Blvd. Central Office of Semnan university of Medical sciences. Semnan. Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.SEMUMS.REC.1401.246

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F09
ICD-10 code description
Unspecified mental disorder due to known physiological condition

Primary outcomes

1

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
1-The Yale Preoperative Anxiety Scale and 2-Visual analog scale of children's anxiety

Secondary outcomes

1

Description
Systolic and Diastolic Blood Pressure
Timepoint
Before and after intervention
Method of measurement
Digital Sphygmomanometer

2

Description
Pulse beat
Timepoint
Before and after intervention
Method of measurement
Wellex portable pulse oximeter model A310 made in Germany

3

Description
Oxygen saturation percentage
Timepoint
Before and after intervention
Method of measurement
Wellex portable pulse oximeter model A310 made in Germany

Intervention groups

1

Description
Intervention group: On the day of surgery, pulse, blood pressure, and blood oxygen saturation percentage of children in the intervention group with the same equipment in the presence of the child's mother and their anxiety with the preoperative anxiety scale of Yale University and visual analog scale (VAS) by a trained colleague of the project , it is measured and recorded. Then, using gloves filled with water and a magic marker that he gives to the child, the main researcher narrates the scenario designed by the research team and in several stages asks the child to identify parts of the face. Draw on each finger of the glove. At the end, for the second time, the aforementioned indicators are measured and recorded by the colleague of the project from the same arm as before and with the same instrument, and the child's anxiety is measured and recorded with the preoperative anxiety scale of Yale University and the visual analog scale (VAS).
Category
Prevention

2

Description
Control group: On the day of surgery, pulse, blood pressure, and blood oxygen saturation percentage of children in the intervention group with the same equipment in the presence of the child's mother and their anxiety with the preoperative anxiety scale of Yale University and visual analog scale (VAS) measured and recorded by a trained colleague of the project. No intervention was done for the control group and they were placed in a comfortable position on the bed for ten minutes, which is equivalent to the intervention time for the intervention group. At the end, for the second time, the aforementioned indicators are measured and recorded by the colleague of the project from the same arm as before and with the same instrument, and the child's anxiety is measured and recorded with the preoperative anxiety scale of Yale University and the visual analog scale (VAS).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Farid Najd Mazhar
Street address
Shafa Yahyaian Hospital , next to the Islamic Council, Mujahideen Islam St, Baharestan Square, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2000
Fax
+98 21 3354 2020
Email
shafa.iums@gmail.com
Web page address
https://shafa.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohamadkhani
Street address
Deputy of Research and Technology, Semnan University of Medical sciences, Basij Blvd, Semnan. Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
Majidmirmohammadkhani@yahoo.com
Web page address
https://semums.ac.ir
Grant name
---
Grant code / Reference number
---
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
10
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
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery. Semnan University of Medical Sciences. 5th kilometer of Damghan road. Semnan. Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4161
Email
nr_dana@yahoo.com
Web page address
https://semums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan university of Medical Sciences, 5th Kilometer of Damghan road,Semnan, Iran
City
Semnan
Province
Semnan
Postal code
+98233513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4161
Email
nr_dana@yahoo.com
Web page address
https://semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery- Semnan University of Medical Sciences- 5th kilometer of Damghan road- Semnan-Iran
City
Semnan
Province
Semnan
Postal code
98233513138111+
Phone
+98 23 3365 4190
Fax
+98 23 3365 4161
Email
nr_dana@yahoo.com
Web page address
https://semums.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Not applicable
Data Dictionary
Not applicable
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