NCT07477353

Brief Summary

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.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

March 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 13, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

mindfulness-based educationfear reactionssleep patternschild

Outcome Measures

Primary Outcomes (1)

  • CHILD AND ADOLESCENT MINDFULNESS AWARENESS SCALE

    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.

    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).

Secondary Outcomes (4)

  • PROBLEMATIC MEDIA USE SCALE

    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).

  • Children's Fear Scale

    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).

  • Sleep Disorder Scale for Children

    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).

  • Parent-Child Relationship Scale

    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).

Study Arms (2)

Mindfulness-Based Stress Reduction (MBSR) Training Program

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Stress Reduction (MBSR) Training Program

control

NO INTERVENTION

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.

Interventions

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.

Mindfulness-Based Stress Reduction (MBSR) Training Program

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doğa College

Ağrı, Ağrı, 04100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

YAZGÜLÜ HEMEDOĞLU, graduate student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and data analysts will be blinded to group allocation. Participants are not blinded due to the nature of the intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an intervention group or a control group and will remain in their assigned group for the entire duration of the study. The intervention and control groups will proceed in parallel and will not cross over or switch interventions at any point.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator and MSc Researcher

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 17, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The individual participant data collected in this study will not be shared publicly in order to protect the participants' privacy and confidentiality. The data collected as part of this study includes individual responses obtained from assessment tools such as the Problematic Media Use Scale, the Children's Fear Scale, the Sleep Disorder Scale for Children, and the Parent-Child Relationship Scale. Since this data may contain personal and sensitive information, it will be used exclusively by the research team in accordance with ethics committee guidelines and data protection regulations. However, in necessary cases and subject to obtaining appropriate ethical approvals, datasets with all identifying information fully anonymized may be shared with relevant researchers for scientific research purposes.

Locations