Time Perception AlteredNCT05898490
The Effect of Animation Therapy on Time Perception in Primary School Children
A study testing Animation Therapy in people with Time Perception Altered, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Perception Altered
- What is being tested?
- Animation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2023to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Time Perception Altered
- Being tested
- Animation Therapy
- Keywords
- time perception, animation therapy, occupational therapy, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation TherapyBehavioural
The process of shooting a stop-motion animation film, is designed according to the interests and leading of the participant.
| Study group | Role | What they receive |
|---|---|---|
| Animation Therapy Group | Experimental | 10 sessions of Animation Therapy (2 session/week) Receives: Behavioral: Animation Therapy |
| Control Froup | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Discrimination Task
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.
Measured: Baseline, preintervention
Time Discrimination Task
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.
Measured: Immediately after the intervention
Time Reproduction Task
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.
Measured: Baseline, preintervention
Time Reproduction Task
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.
Measured: Immediately after the intervention
Executive Functions and Occupational Routines Score
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.
Measured: Baseline, preintervention
Executive Functions and Occupational Routines Score
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.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start29 May 2023
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Perception AlteredStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Belen, Kutahya Health Sciences University
- Investigators
- Gonca Bumin, Prof., Study director, Hacettepe UniversityÖzgün Belen, MSc, Principal investigator, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898490
- Sponsor's protocol ID
- 2023-03/06
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animation Therapy on Time Perception in Primary School Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05898490
- Acronym / sponsor ID
- 2023-03/06
- Conditions
- Time Perception Altered
- Keywords
- time perception, animation therapy, occupational therapy, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animation Therapy Group | Experimental | Behavioral: Animation Therapy10 sessions of Animation Therapy (2 session/week) |
| Control Froup | No intervention | –No intervention |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animation TherapyThe process of shooting a stop-motion animation film, is designed according to the interests and leading of the participant. | Behavioural | Animation Therapy Group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Time Perception Altered
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonca Bumin, Prof. study director
Hacettepe University
Özgün Belen, MSc principal investigator
Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation Therapy in people with Time Perception Altered, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Discrimination Task (time frame: Baseline, preintervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.