Comparison of the effectiveness of storytelling, play therapy and common hospital protocol on the severity of preoperative anxiety in children 3 to 6 years before and after the intervention
Design
A randomized clinical trial including a control group and non-blinded parallel groups was performed on 102 pre-school children (3 to 6 years) who were admitted to the hospital for a surgery. A simple random selection was employed using a table of random numbers to assign the children to one of the intervention group 1, group 2 and the control group. This process continued to the extent that the required sample size was attained in each group.
Settings and conduct
The current study was carried out at Golestan Hospital in Ahvaz. Children who were admitted for surgery selected according to the study criteria using a random allocation procedure. It should be noted that blinding was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: preschool children, parental consent, mental wellbeing, prior 12 months non-admission to hospital or surgery, no concomitant treatment with medications.
Exclusion Criteria: lack of proper communication.
Intervention groups
Intervention group one: Play therapy was used in this group. According to the age and gender of the child, suitable toys were given to her/him to choose one or some of the toys based on their interests. This intervention lasted for about 20 minutes.
Intervention group two: Storytelling was used in this group. According to the child’s age and gender, some books were read to him/her by the researcher or child’s parents for about 20 minutes.
Control group: In this group the common hospital’s protocol included the presence of child’s parents and/or hospital personnel, and medication under the supervision of the anesthesiologist was used.
Main outcome variables
level of anxiety before surgery of children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181210041915N3
Registration date:2020-12-19, 1399/09/29
Registration timing:retrospective
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Kourosh Zarea
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8071
Email address
zarea_k@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
2020-01-05, 1398/10/15
Actual recruitment end date
2020-05-09, 1399/02/20
Trial completion date
2020-05-09, 1399/02/20
Scientific title
Comparing the effectiveness of play therapy, storytelling and routine protocol on preoperative anxiety in preschool age children(3-6 years)
Public title
Comparing the effectiveness of play therapy and storytelling on preoperative anxiety in preschool age children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children of pre-school age
Parental informed consent
Mentally health
No admitted to hospital or surgery in pervious 12 months
No concomitant drug treatment
Exclusion criteria:
Inability to communicate properly
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Actual sample size reached:
97
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, the children who were admitted to the hospital for a surgery and were representative of the inclusion criteria were selected using a simple random allocation strategy based on a table of random numbers. The procedure was as follows: a number was called from the table when a child patient was brought to the operating room. If the last digit of the randomly selected number was one of 1, 2 or 3, the candidate was assigned to the first intervention group (the storytelling group) and if the last digit of the number was one of 4, 5 or 6, the candidate had to enter the second intervention group (the play therapy group). Finally, if the last digit of the selected number was one of 7, 8 or 9, the nominated child was considered a control group participant (receiving routine treatments) and if the last digit was zero, another number had to be selected from the table.
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
ethical Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Research Ethics Committee, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.AJUMS.REC.1399.104
Health conditions studied
1
Description of health condition studied
Pre-surgery anxiety in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
preoperative anxiety in pre-school age children
Timepoint
Anxiety measurement was performed before the intervention and immediately after the intervention.
Method of measurement
Observational Scale of Behavioral Distress-Revised (OSBD-R)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: The intervention in this group was Play Therapy. After random selection the child is assigned to this group and by entering the operation room, the child is assessed by the researcher. While the child is brought to the operation room on a stretcher or in a wheelchair, he/she is given the chance to pick toys based on his/her gender. For example, toys such as dolls and kitchen utensils or household objects were options for female participants, and a car, a cannon, a rifle, or a set of building blocks were available for the male participants to choose from and start playing. This intervention lasted for about 20 minutes under the supervision of the researcher.
Category
Behavior
2
Description
Intervention group two: The method of the intervention in group two was storytelling. After random selection the child is assigned to this group, then he/she is assessed by the researcher. While the child is brought to the operation room on a stretcher or in a wheelchair, some story books such as “Hassani” are chosen based on the gender of the child from a series of short stories. These stories were visually appealing to the children because of varied and colorful images. The content was also relevantly chosen to include areas like, education, health, nutrition, discipline, and social regulation training. These books were read by the researcher, but in the presence of the parents. If the child did not like it, though, the parents were given the books to read them to the child, under the researcher's supervision; this intervention also lasted for 20 minutes.
Category
Behavior
3
Description
Control Group: The Common Hospital Protocol was followed for the participants in this group. Midazolam was prescribed by the anesthesiologist, for the purpose of child’s sedation, and if the child’s anxiety was not relieved, thiopental sodium was used at sufficient doses to cause drowsiness and/or loss of consciousness. However, for the children who did not require sedation, only their parents or often a health care professional such as an anesthesiologist or an operating room specialist were permitted to accompany the child and stay.
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8621
Email
research@ajums.ac.ir
Grant name
Grant code / Reference number
NCRCCD-9904
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Kourosh Zarea
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Nursing and Midwifery School, Ahvaz Jundishapur university of medical sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135864565
Phone
+98 61 3373 8071
Fax
+98 61 3373 8333
Email
zarea_k@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kourosh Zarea
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Nursing and Midwifery School, Ahvaz Jundishapur university of medical sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135864565
Phone
+98 61 3373 8071
Fax
+98 61 3373 8333
Email
zarea_k@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kourosh Zarea
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135864565
Phone
+98 61 3373 8071
Fax
+98 61 3373 8333
Email
zarea_k@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data files can be provided if necessary
When the data will become available and for how long
Not yet published
To whom data/document is available
Academic institutions and universities
Under which criteria data/document could be used
Researchers working in this field, if they obey full confidentiality and just use for scientific proposes purely.
From where data/document is obtainable
By phone, fax or email and provide an official letter of introduction from the scientific institute
What processes are involved for a request to access data/document
First, he/she sends an official letter of introduction and a letter of request to access the data via email. When the letters were reviewed after a maximum of 20 days, he/she is given the access.