Impact of pictorial and movable story book on preoperative anxiety and postoperative behavioral disturbances among hostopitalized 4 - 8 year-old Children with tonsillectomy.
The present study will evaluate the impact of pictorial and movable story book on preoperative anxiety and postoperative behavioral disturbances. The aim of this study will be to reduce anxiety and behavioral disorders on the children who experienced the tonsils surgery. Sixty children will be taken a part in this study. Inclusion criteria: age between 4 -8 years; Lack of chronic diseases (cancer, liver disease and kidney); Have good speaking and hearing abilities; The presence of a parent or guardian at the time of admission; No surgery and hospitalization in the past; The lack of central nervous system diseases and mental illness; Exclusion criteria: Children and parents not wanting to continue studying; Stopping the surgery under any conditions; lack of cooperation in listening to the story. Subjects will be selected through the random numbers chart (30 numbers from 0 to 9 would be randomly selected. We would write AB statement (intervention-control) for each selected number from 0-4 and we would write BA statement (control-intervention) if the number is among 5-9. Then we would put them in one of the groups under study: first group listening to pictorial and movable story book about Tonsils surgery and hospitalization at night before surgery and another group no story book would be read routinely. The level of anxiety of the children before and after surgery will be evaluated using RCMAS questionnaire and the level of behavioral disturbances after surgery will be evaluated using a created researcher's questionnaire by the phone in 10 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082223704N1
Registration date:2015-12-13, 1394/09/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-13, 1394/09/22
Registrant information
Name
Zohreh Sekhavatpour
Name of organization / entity
Dezfoul University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 4222 0627
Email address
sekhavat.z@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Dezfoul University of Medical Sciences
Expected recruitment start date
2015-07-19, 1394/04/28
Expected recruitment end date
2015-12-19, 1394/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of pictorial and movable story book on preoperative anxiety and postoperative behavioral disturbances among hostopitalized 4 - 8 year-old Children with tonsillectomy.
Public title
Impact of pictorial and movable story book on preoperative anxiety and postoperative behavioral disturbances.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 4 -8 years; Lack of chronic diseases (cancer, liver disease and kidney); Have good speaking and hearing abilities; The presence of a parent or guardian at the time of admission; No surgery and hospitalization in the past; The lack of central nervous system diseases and mental illness; Exclusion criteria: Children and parents not wanting to continue studying; Stopping the surgery under any conditions; lack of cooperation in listening to the story.
Age
From 4 years old to 8 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
1
Registry name
---
Secondary trial Id
---
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Dezfoul University of Medical Science
Street address
Azadegan Blvd
City
dezful
Postal code
Approval date
2015-07-29, 1394/05/07
Ethics committee reference number
IR.Dums.REC.1394.4
Health conditions studied
1
Description of health condition studied
Situational anxiety and behavioral disturbances
ICD-10 code
F40.2
ICD-10 code description
specific (isolated) phobias
2
Description of health condition studied
Situational anxiety and behavioral disturbances
ICD-10 code
R46.6
ICD-10 code description
Undue concern and preoccupation with stressful events
Primary outcomes
1
Description
Manifest and hidden Anxiety children
Timepoint
Immediately after the intervention and before surgery and after 10 days
Method of measurement
RCMAS scale
Secondary outcomes
1
Description
Behavioral disturbances
Timepoint
Before and 10 days after operation
Method of measurement
Created researcher questionnaire
Intervention groups
1
Description
Intervention group: the story book will be read For 30 minutes on the night before surgery. The researcher would fill the anxiety and the behavioral disorders questionnaire before and after surgery and 10 days after through a phone call with the child's mother. This story will be designed in four parts. Part I: Presentation of information. In this section, two types of information would be given to children. Information regarding procedures includes basic information about the surgery and everything from the entry to exit from the hospital and sensory information includes feelings such as pain, itching, burning, pain in the region of the cut, and nausea and numbness that can be experienced during the treatment would be told to the child. Part II: Behavioral guidelines. In this section, effective behaviors such as breathing before the start of anesthesia would be told to the child and they would be playing the roles. And the child would be asked to repeat them. Part III: Cognitive interventions. In this part of the story book, the researcher would show images of the operating room along with all the equipment used in operating rooms to the child and this will change the child's recognition of the fact that these instruments will be painful. After telling the story for the child, he will be asked to do the works and tell his parents about them in order to review them in his mind. Part IV: Emotional interventions. In the entire process in this story book, the child would be asked to express his feelings and emotions such as anxiety or fear clearly. The child may tell us which part or parts make him frightened more or what he is anxious about.
Category
Behavior
2
Description
Control group: Only routine will be performed. In order to avoid any bias, the anxiety questionnaire would be filled before and after surgery and ten days after intervention of the assessment group including child's clinical psychologist, a nurse and the researcher in this section. Then the researcher would review the child's behavioral disorder through a self-made questionnaire before surgery and ten days after surgery by a phone calling talking to the child's mother
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Big Hospital Dezfoul
Full name of responsible person
Zohreh Sekhavatpour
Street address
Beginning of the road Andimeshk
City
Dezfoul
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Dezfoul University of Medical Sciences
Full name of responsible person
Dr Fereydon Nirozad
Street address
Azadegan Blvd, Dezfoul University of Medical Science, Research Center
City
Dezfoul
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, Dezfoul 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
Dezfoul University of Medical Science
Full name of responsible person
Seyedeh Maryam Molayi
Position
Research Manager
Other areas of specialty/work
Street address
Azadegan Blvd, Dezfoul University of Medical Science, Research Center
City
Dezfoul
Postal code
64611-58119
Phone
+98 61 4242 9731
Fax
+98 42429532
Email
Reaserch@dums.ac.ir
Web page address
Http://Research.dums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Science
Full name of responsible person
Zohreh sekhavatpour
Position
Master of Nursing
Other areas of specialty/work
Street address
Dezfoul University of Medical Science, Paramedicine
City
Dezfoul
Postal code
64611-58119
Phone
+98 61 4222 0627
Fax
+98 42429532
Email
Sekhavat.z@dums.ac.ir
Web page address
Http://Research.dums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Science
Full name of responsible person
Zohreh Sekhavatpour
Position
Faculty Dezfoul University of Medical Science
Other areas of specialty/work
Street address
Dezfoul University of Medical Science, Paramedicine
City
Dezfoul
Postal code
64611-58119
Phone
+98 61 4222 0627
Fax
+98 42429532
Email
Sekhavat.z@dums.ac.ir
Web page address
Http://Research.dums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)