NCT07274553

Brief Summary

This randomized controlled trial investigated the impact of a Mindfulness-Based Stress Reduction (MBSR) program on digital game addiction, perceived stress, and sleep quality among adolescents. The primary research questions were as follows: Does the Mindfulness-Based Stress Reduction Program influence adolescents' levels of digital game addiction? Does the Mindfulness-Based Stress Reduction Program affect adolescents' perceived stress levels? Does the Mindfulness-Based Stress Reduction Program impact adolescents' sleep quality? Participants, aged 12-16, will be randomly allocated to either an intervention group, which will undergo an 8-week MBSR program, or a control group, which will continue with routine school activities. The MBSR program comprises weekly 40-minute sessions that include breath awareness, body scanning, mindful movement, and emotion regulation exercises. Data will be collected using the Digital Game Addiction Scale, Perceived Stress Scale, and Pittsburgh Sleep Quality Index at both the pretest and posttest stages. This study is anticipated to contribute to the development of preventive strategies for behavioral addictions and enhance the emotional well-being and sleep patterns of adolescents.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

November 3, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

7 days

First QC Date

November 27, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

Mindfulness-Based Stress ReductionAdolescentsDigital Game AddictionNursingStressSleep Quality

Outcome Measures

Primary Outcomes (1)

  • Digital Game Addiction Score

    Measured by the Digital Game Addiction Scale. Score range: 7 (minimum) to 35 (maximum). Higher scores indicate worse outcomes, representing higher levels of digital game addiction.

    Baseline (Week 0) and Post-intervention (Week 8)

Secondary Outcomes (2)

  • Perceived Stress Score

    Baseline (Week 0) and Post-intervention (Week 8)

  • Sleep Quality Score

    Baseline (Week 0) and Post-intervention (Week 8)

Study Arms (2)

Experimental: Mindfulness-Based Stress Reduction (MBSR)

EXPERIMENTAL

Participants in this group will receive an 8-week Mindfulness-Based Stress Reduction (MBSR) program specifically designed for adolescents. Each session lasts approximately 40 minutes and includes breathing awareness, body scan, mindful movement, and emotional regulation exercises. The sessions are conducted once a week in a classroom setting by a trained instructor. Participants are encouraged to practice mindfulness exercises at home between sessions.

Behavioral: Mindfulness-Based Stress Reduction Program (MBSR)

No Intervention: Control Group

NO INTERVENTION

Participants in this group will not receive any mindfulness or behavioral intervention. They will continue their normal school routine and educational activities during the study period. After the study concludes, they will be offered a brief introductory mindfulness session as an ethical consideration.

Interventions

The intervention consists of an 8-week Mindfulness-Based Stress Reduction (MBSR) program adapted for adolescents. Each weekly session lasts approximately 40 minutes and is conducted in a classroom setting by a trained instructor. The program includes breathing awareness, body scan, mindful movement, and emotion regulation exercises. Participants are encouraged to practice mindfulness at home between sessions using simple guided exercises.

Experimental: Mindfulness-Based Stress Reduction (MBSR)

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents aged between 12 and 16 years
  • Enrolled in a high school under the Muş Provincial Directorate of National Education
  • Voluntarily agreed to participate and provided informed consent (along with parental consent)
  • Able to attend all eight weeks of the mindfulness sessions
  • Sufficient literacy and comprehension to complete self-report questionnaires

You may not qualify if:

  • Diagnosed psychiatric, neurological, or developmental disorder
  • Currently receiving psychological therapy or participating in another behavioral program
  • Regular use of medication that affects sleep, mood, or cognitive function
  • Absence from more than two MBSR sessions
  • Declined or withdrew consent during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University, Health Sciences Institute

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to an intervention group that received an 8-week Mindfulness-Based Stress Reduction (MBSR) program and a control group that received no intervention. The study followed a two-arm, parallel-group, pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 10, 2025

Study Start

November 3, 2025

Primary Completion

November 10, 2025

Study Completion

January 20, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations