- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477353
The Behavioral Effects of Mindfulness-Based Technology Use Training in Preschool Children
The Effect of Mindfulness-Based Technology Use Training Applied to Preschool Children on Media Use, Sleep, Fear, and Close Relationships
With the rapid advancement of technology, the use of digital devices has become widespread even in early childhood. While the conscious and controlled use of technology in the preschool period can contribute to children's development, prolonged and uncontrolled screen use can lead to various negative consequences such as sleep problems, attention issues, increased anxiety levels, and difficulties in social relationships. In particular, exposure to violent media content can cause children to perceive the world as more frightening and experience anxiety.
Mindfulness-based training supports individuals in directing their attention to the present moment, recognizing their emotions, and accepting their experiences without judgment. Such training is known to develop self-regulation, attention, and emotional awareness skills in children.
The purpose of this study is to examine the effect of mindfulness-based technology use training applied to preschool children on their media usage habits, sleep patterns, fear levels, and parent-child relationship. The study is planned as a randomized controlled trial with an experimental design. The intervention group will receive mindfulness-based technology use training, while the control group will receive no intervention. The study expects that mindfulness-based training will reduce children's screen time, improve sleep quality, decrease fear levels, and strengthen parent-child relationships. This study aims to contribute to the development of intervention programs that support healthy technology use in early childhood.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The rapid advancement of technology has increased the use of portable and accessible devices, offering new opportunities not only for adults but also for individuals in early childhood. Particularly during the preschool education period between 36 and 72 months, children experience significant changes in their cognitive, physical, language, social-emotional, and sexual development. Technology is also a major environmental factor influencing children's development during this period.
Conscious exposure to technological devices has been observed to contribute positively to children's preparation for school and cognitive development. However, the misuse of technology can lead to various negative consequences and negatively affect children's development. Children who spend long periods of time in front of screens may experience problems such as reduced sleep duration and difficulty falling asleep. Blue light, in particular, is associated with sleep problems by reducing the release of the hormone melatonin. There is an inverse relationship between delayed bedtimes and reduced sleep duration and screen-based media consumption. Furthermore, long periods spent in front of screens can also lead to problems such as attention deficit, poor command skills, and auditory attention deficit. For preschool children, prolonged screen use has been associated with cognitive activities, attention problems, aggressive behavior, physical inactivity, obesity, and sleep problems.
Children frequently encountering content containing violence and aggression on screens can lead to them becoming desensitized to violence, a decrease in their ability to empathize, perceiving the world as a more frightening place, and exhibiting aggressive behavior towards others. Children affected by violent content on television begin to feel fear and anxiety, thinking that they may experience such content in real life. The center in children's brains that distinguishes between reality and unreality is not as differentiated as it is in adults. Children perceive situations that are not actually frightening as real situations and may be afraid. Mindfulness is defined as focusing attention on the present moment with a non-judgmental and accepting attitude and maintaining awareness of the current experience.
Mindful awareness is defined as a state of being present in the current moment. This concept involves directing attention to what is happening at the present time, recognizing how attention is focused, and accepting observed experiences calmly and without judgment. On the other hand, mindfulness is defined as a unique capacity of consciousness that describes a person being aware of both their thoughts and actions in the present moment. Mindfulness-based educational programs aim to help children accept their emotions. Through various activities implemented in this process, children are helped to realize that experiencing feelings such as restlessness and occasional unhappiness are a natural part of everyday life. Particularly when encountering unpleasant emotions (e.g., sadness, anger, etc.), questions such as "How can we cope with these emotions?" and "Why do we sometimes feel these emotions?" are used to increase children's self-awareness of their emotions. In this regard, children are encouraged to accept that challenging emotions are a normal part of life, and this acceptance contributes to reducing their stress levels in daily life. Recent studies have shown that mindfulness practices in early childhood support the development of various skills, including self-regulation skills. In short, individuals with mindfulness direct their attention to the present moment, accept their experiences without judgment, and observe their internal processes, refusing to automatically continue their reactions. Mindfulness, which plays an important role in supporting physical and psychological health, not only develops an individual's emotion regulation skills but also enables them to exhibit more functional attitudes in daily life relationships, cope more effectively with problems, and increase their mental well-being, psychological resilience, and life satisfaction. Research findings examining the relationship between mindfulness levels, technology use, sleep quality, and fear levels suggest that these findings could serve as a basis for interventions aimed at reducing individuals' addictive behaviors, improving sleep quality, and reducing fear levels.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: YAZGÜLÜ HEMEDOĞLU, graduate student
- Phone Number: +90 543 205 1485
- Email: yzglhmdgl@gmail.com
Study Locations
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Ağrı
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Ağrı, Ağrı, Turkey (Türkiye), 04100
- Doğa College
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Contact:
- Yazgülü HEMEDOĞLU
- Phone Number: +90 5432051485
- Email: yzglhmdgl@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Obtaining verbal and written parental consent
- Being in the 3-6-year-old preschool age range
- Agreeing to participate regularly in the mindfulness training program
- Being open to communication and group interaction during the training process
- Not having previously participated in a similar psychological resilience or emotion regulation program
Exclusion Criteria:
Refusing to participate in the study or withdrawing consent during the process
- Having a cognitive or physical impairment that would prevent the completion of the questionnaires
- Having a level of absenteeism that could affect the implementation of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-Based Stress Reduction (MBSR) Training Program
Participants will be assigned to intervention and control groups using a randomization method.
Preschool children in the intervention group will receive a 6-week mindfulness-based technology awareness training program.
The program will consist of two sessions per week and will include age-appropriate mindfulness activities designed to support children's attention, emotional awareness, self-regulation, and conscious technology use.
Sessions will include breath awareness, emotional awareness, relaxation, and attention-focusing exercises, as well as mindfulness activities related to technology use.
Parents will be involved throughout the training process, and session content will be shared with them.
No training will be provided to the control group, but pre-test and post-test measurements will be conducted simultaneously with the intervention group.
|
The intervention consists of a mindfulness-based technology use awareness education program designed for preschool children aged 3-6 years.
The program will be implemented over 6 weeks, with two sessions per week conducted in a classroom setting.
Each session will include short, developmentally appropriate mindfulness activities lasting approximately 5-10 minutes, such as breathing awareness, attention focusing, emotional awareness, relaxation exercises, and activities that promote conscious and balanced technology use.
The program aims to improve children's self-regulation, attention, emotional awareness, and responsible media use habits.
Throughout the intervention period, parents will be informed about the session content and encouraged to support their children in practicing the activities at home to reinforce the skills learned during the sessions.
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|
No Intervention: control
Participants will be randomly assigned to an intervention group or a control group.
The intervention group will receive a 6-week mindfulness-based technology use awareness education program designed for preschool children.
The program will include two sessions per week and will consist of age-appropriate mindfulness activities such as breathing awareness, attention focusing, emotional awareness, relaxation exercises, and activities that promote conscious technology use.
The aim of the program is to support children's self-regulation, attention, emotional awareness, and responsible media use.
Parents will be informed about the session content and encouraged to support their children in practicing the activities at home.
The control group will not receive the mindfulness-based education program; however, data will be collected from both groups simultaneously through pre-test and post-test measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CHILD AND ADOLESCENT MINDFULNESS AWARENESS SCALE
Time Frame: From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
|
Mindfulness levels in children will be assessed using the Child and Adolescent Mindfulness Measure (CAMM).
The scale consists of 10 items rated on a 5-point Likert scale ranging from 0 (never) to 4 (always).
Before calculating the total score, items are reverse coded (0=4, 1=3, 3=1, 4=0; the score of 2 remains unchanged).
The total score is obtained by summing all item scores.
Possible total scores range from 0 to 40, with higher scores indicating higher levels of mindfulness.
The scale does not include subscales or a specific cutoff score.
CAMM is a widely used self-report measure designed to assess mindfulness levels in children and adolescents.
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From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Fear Scale
Time Frame: From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
|
The Children's Fear Scale was developed by Özalp (2018) to assess children's levels of fear.
The scale is a visual rating tool consisting of facial expressions representing different levels of fear.
Participants (children or parents) are asked to select the face that best represents the child's level of fear.
Facial expressions on the scale are scored on a scale of 0 to 4. A score of 0 indicates no fear, while a score of 4 represents the highest possible level of fear.
Higher scores on the scale indicate a higher level of fear.
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From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
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Sleep Disorder Scale for Children
Time Frame: From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
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The Sleep Disorder Scale for Children was developed by Ağadayı (2020) to assess sleep disorders in children.
The scale consists of a total of 26 items and assesses six subscales: difficulties initiating and maintaining sleep, sleep-related breathing disorders, sleep arousal disorders, sleep-wake transition disorders, excessive daytime sleepiness, and excessive sweating during sleep.
Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (always).
The total score on the scale ranges from 26 to 130. Higher scores indicate more sleep disorder symptoms in children.
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From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
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Parent-Child Relationship Scale
Time Frame: From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
|
The Parent-Child Relationship Scale is a self-report measure developed by Hetherington and Clingempeel (1992) to assess the quality of the relationship between parents and children.
The scale consists of a total of 15 items and includes subscales that assess the positive and negative aspects of the parent-child relationship.
Participants respond to each item using a 5-point Likert-type scale ranging from 1 (not at all) to 5 (extremely).
Scores obtained from the scale reflect the quality of the parent-child relationship.
The Turkish adaptation was conducted by Aytaç, Çen, and Yüceol (2018), and the internal consistency coefficients were reported as 0.81 for the positive relationship subscale and 0.80 for the negative relationship subscale.
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From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
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PROBLEMATIC MEDIA USE SCALE
Time Frame: From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
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Problematic media use levels in children will be assessed using the Problematic Media Use Scale.
The scale consists of 9 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always).
The total score is calculated by summing all item scores and dividing by the number of items (9) to obtain a mean score.
Possible scores range from 1 to 5, with higher scores indicating higher levels of problematic media use in children.
The scale is designed to evaluate problematic patterns of media use in childhood.
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From the baseline (pre-test) at the start of the intervention through to immediately after the 6-week mindfulness-based technology use program (post-test).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AICU-SBF-YH-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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