NCT05898490

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 1, 2023

Last Update Submit

June 21, 2023

Conditions

Keywords

time perceptionanimation therapyoccupational therapychildren

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Immediately after the intervention

Study Arms (2)

Animation Therapy Group

EXPERIMENTAL

10 sessions of Animation Therapy (2 session/week)

Behavioral: Animation Therapy

Control Froup

NO INTERVENTION

No intervention

Interventions

The process of shooting a stop-motion animation film, is designed according to the interests and leading of the participant.

Animation Therapy Group

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özel Yaşam Köyü İlkokulu

Eskişehir, Turkey (Türkiye)

Location

Study Officials

  • Gonca Bumin, Prof.

    Hacettepe University

    STUDY DIRECTOR
  • Özgün Belen, MSc

    Kütahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

May 29, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations