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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Animation Therapy Group
10 sessions of Animation Therapy (2 session/week)
Behavioral: Animation Therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Özgün Belen, MSc, Kutahya 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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