- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05898490
The Effect of Animation Therapy on Time Perception in Primary School Children
June 21, 2023 updated by: Ozgun Belen, Kutahya Health Sciences University
The Effect of Animation Therapy on Time Perception in Primary School Children: A Randomized Controlled Study
The aim of the study is to determine the effects of animation therapy on time perception and daily activity routine performances of primary school children.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Time is a process that forms the basis of executive functions used to reveal adaptive behavior and motor performance.
However, the way we perceive time can be changed by different factors.
This may reveal changes in executive functions such as decision making, behavioral inhibition, planning, and accordingly, in the performance levels and daily routines of daily living activities.
Animation therapy is the therapeutic use of the process of shooting a stop-motion animation film.
It creates a "flow" effect by nature.
The concept of flow includes the loss of the sense of time.
In this study, it is aimed to examine whether animation therapy has an effect on the perception of time and daily activity routines in primary school children.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Eskişehir, Turkey
- Özel Yaşam Köyü İlkokulu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being between the ages of 7-10
- Absence of any orthopedic, neurodevelopmental, and psychiatric problems/diagnosis
- Continuing formal education
- Voluntarily agreeing to participate in the research
Exclusion Criteria:
- Receiving orthopedic, neurodevelopmental and psychiatric diagnosis during the study period
- To be absent from the study process or to quit the process
- Not participating in the first and last evaluations
- Voluntary refusal to participate or continue with the research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Animation Therapy Group
10 sessions of Animation Therapy (2 session/week)
|
The process of shooting a stop-motion animation film, is designed according to the interests and leading of the participant.
|
No Intervention: Control Froup
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Discrimination Task
Time Frame: Baseline, preintervention
|
Time Discrimination Task is based on the individual's perception of the time difference of two different gaps between two pairs of sequentially given stimuli.
Generally, the person is asked to indicate which pair is longer or shorter between two pairs of stimuli of certain lengths, which are given visually and/or audibly.
Leveling is performed with the UDTR (Up-Down Transformed-Response) adaptive procedure method to progress the test and determine the participant's discrimination threshold.
|
Baseline, preintervention
|
Time Discrimination Task
Time Frame: Immediately after the intervention
|
Time Discrimination Task is based on the individual's perception of the time difference of two different gaps between two pairs of sequentially given stimuli.
Generally, the person is asked to indicate which pair is longer or shorter between two pairs of stimuli of certain lengths, which are given visually and/or audibly.
Leveling is performed with the UDTR (Up-Down Transformed-Response) adaptive procedure method to progress the test and determine the participant's discrimination threshold.
|
Immediately after the intervention
|
Time Reproduction Task
Time Frame: Baseline, preintervention
|
In Time Reproduction Task, the participants are asked to produce a stimulus similar to the duration of the stimulus presented to them at certain durations.
In our study, visual and auditory stimuli of 200ms, 500ms and 800ms will be presented to the person in the time reproduction task, as in the time discrimination task.
These stimuli will be presented in a completely random order, not in a specific order, and each stimulus will be presented 10 times, with a total of 30 consecutive stimuli.
A gap of 2000 ms will be left between both stimuli to allow enough time for the person to reproduce the stimulus.
The ratio of the absolute value of the difference between the participant's reproduced time and the target time to the target time will be calculated.
|
Baseline, preintervention
|
Time Reproduction Task
Time Frame: Immediately after the intervention
|
In Time Reproduction Task, the participants are asked to produce a stimulus similar to the duration of the stimulus presented to them at certain durations.
In our study, visual and auditory stimuli of 200ms, 500ms and 800ms will be presented to the person in the time reproduction task, as in the time discrimination task.
These stimuli will be presented in a completely random order, not in a specific order, and each stimulus will be presented 10 times, with a total of 30 consecutive stimuli.
A gap of 2000 ms will be left between both stimuli to allow enough time for the person to reproduce the stimulus.
The ratio of the absolute value of the difference between the participant's reproduced time and the target time to the target time will be calculated.
|
Immediately after the intervention
|
Executive Functions and Occupational Routines Score
Time Frame: Baseline, preintervention
|
This scale evaluates children's performance in daily activity routines, was developed by Fisch and Rosenblum in 2014.
This scale evaluates the daily routines and executive functions of children aged 6-12 years, according to the opinion of their parents/caregivers.
It consists of 3 sub-dimensions: Morning and Evening Routines (16 items), Game and Leisure Routines (7 items), and Social Routines (7 items).
It is in the form of a five-point Likert scale and each item can be scored between 1 (never) and 5 (always).
A high score indicates that the child's performance is high.
The scale, which consists of 30 items in total, can be completed in approximately 15 minutes.
|
Baseline, preintervention
|
Executive Functions and Occupational Routines Score
Time Frame: Immediately after the intervention
|
This scale evaluates children's performance in daily activity routines, was developed by Fisch and Rosenblum in 2014.
This scale evaluates the daily routines and executive functions of children aged 6-12 years, according to the opinion of their parents/caregivers.
It consists of 3 sub-dimensions: Morning and Evening Routines (16 items), Game and Leisure Routines (7 items), and Social Routines (7 items).
It is in the form of a five-point Likert scale and each item can be scored between 1 (never) and 5 (always).
A high score indicates that the child's performance is high.
The scale, which consists of 30 items in total, can be completed in approximately 15 minutes.
|
Immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Özgün Belen, MSc, Kütahya Health Sciences University
- Study Director: Gonca Bumin, Prof., Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2023
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
November 1, 2023
Study Registration Dates
First Submitted
June 1, 2023
First Submitted That Met QC Criteria
June 1, 2023
First Posted (Actual)
June 12, 2023
Study Record Updates
Last Update Posted (Actual)
June 23, 2023
Last Update Submitted That Met QC Criteria
June 21, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2023-03/06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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