To determine the effect of family-centered play therapy (FCPT) on anxiety in school-age children admitted to pediatric wards.
Design
This research is a Quasi-experimental study. The patients were randomly assigned to intervention and control groups (40 people in each group) based on random allocation.
Settings and conduct
The study location was in pediatric departments 1 and 2 of Afzalipur Hospital, Kerman University of Medical Sciences. Hospitalized children were included in the study if eligible and randomly assigned to the intervention and control groups by simple random method. Blinding was not done in this study. Parents in the intervention group played Dominos games with their children. The control group received routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized children aged 6-11 years.
At least 24 hours have passed since their hospitalization.
Their parents should be with the child as the main caregivers.
The child has age-appropriate cognitive (mental) development.
The child does not have mental disorders.
The child does not have an acute physical disorder.
The child has not been abused.
Intervention groups
In the intervention group, the parents were taught to play dominoes with their child twice a day (30 minutes each time) for three days. Parents were asked to play with the child when the child wished to play at least twice a day for half an hour. The control group received routine care.
Main outcome variables
The anxiety caused by hospitalization in children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160914029817N11
Registration date:2022-12-03, 1401/09/12
Registration timing:retrospective
Last update:2022-12-03, 1401/09/12
Update count:0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Esmat Nuhi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
e_nuhi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-30, 1398/08/08
Expected recruitment end date
2021-02-26, 1399/12/08
Actual recruitment start date
2019-12-22, 1398/10/01
Actual recruitment end date
2020-04-27, 1399/02/08
Trial completion date
2021-02-26, 1399/12/08
Scientific title
The effect of family-centered play therapy on anxiety in school-age children admitted to pediatric wards
Public title
The effect of family-centered play therapy on anxiety in admitted children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized children should be 6-11 years old.
At least 24 hours have passed since their hospitalization.
Their parents should be with the child as the main caregivers.
The child should have age-appropriate cognitive (mental) growth and development.
The child does not have mental disorders.
The child does not have an acute physical disorder.
The child has not been subjected to child abuse.
Exclusion criteria:
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected by a simple random sampling method based on random allocations using coin-tossing lottery. The intervention group was considered the head and the control group was considered to be the tail. Based on the sample size (40 people in each group), a coin was thrown to the number of people and people were randomly assigned to two groups. In order to prevent the interference between the groups, sampling was done from pediatric departments 1 and 2 during two weeks. The conditions of nursing care were completely similar in the two departments.
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 Kerman University of Medical Sciences
Street address
Deputy of Research and Technology, At the beginning of Ebnsina Street, Somayeh Crossroad (Tahmasb Abad)
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-10-21, 1398/07/29
Ethics committee reference number
IR.KMU.REC.1398.360
Health conditions studied
1
Description of health condition studied
The anxiety of hospitalized children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
anxiety
Timepoint
Before the intervention and the end of the third day after the intervention.
Method of measurement
The Spielberger State-Trait Anxiety Inventory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the objectives of the study were explained to the children and parents in very simple language. Then, oral consent was obtained from the children and written consent was obtained from their parents. The questionnaire including demographic information and the Spiel Berger anxiety questionnaire was completed by the researcher in the second 24 hours of the child's hospitalization. The reason for completing the questionnaire on the second day of hospitalization was the stability of the parents' mental state and the assignment of the child in terms of diagnosing the disease and starting the treatment process. The researcher gave the parents in the intervention group a Dominoes game package(Dominoes is a game played with rectangular pieces) and taught them to play with their child at least twice a day for three days and 30 minutes each time. The playing time was determined based on the child’s request. At the end of the third day of the intervention, the researcher again completed the Spiel Berger Anxiety Inventory for each child.
Category
Other
2
Description
Control group: The control group did not receive any intervention in the hospital except for routine care including medication interventions and teaching the necessary care to parents and children. There was no well-organized program for family-centered play therapy. The Spiel Berger Anxiety Inventory was also completed by the members of the control group on the second day of hospitalization and three days after the intervention. At the end of the study, the control group was given a toy package.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Zahra Akhondzadeh
Street address
Afzalipour Medical Education Center, Next to Shahid Bahonar University, Imam Khomeini Highway.
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
+98 34 3325 7770
Email
smnouhi@yahoo.com
Web page address
https://vresearch.kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpourafshar
Street address
Deputy of Research and Technology, At the beginning of Ebnsina Street, Somayeh Crossroads (Tahmasb Abad).
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3132 5220
Fax
+98 34 3132 5218
Email
KMU_RESEARCH@YAHOO.COM
Web page address
https://vresearch.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Esmat Nouhi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Razi School of Nursing and Midwifery, campus of Kerman University of Medical Sciences, Haft Bagh Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
smnouhi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Esmat Nouhi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
medical Education
Street address
Campus of Kerman University of Medical Sciences, Haft Bagh Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
smnouhi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Esmat Nouhi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Haft Bagh Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
smnouhi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In order to build trust and maintain ethics in the research, the demographic characteristics of the participants were completely unrecognizable and confidential in the release of information. There is no more information