NCT06081751

Brief Summary

his randomized controlled trial aimed to evaluate the effectiveness of a nurse-led traditional children's games program on weekly internet use and perceived stress among middle school students in Türkiye. Students who used the internet for more than two hours per day were randomly assigned to either an intervention group or a control group. The intervention group participated in a structured traditional children's games program for 60 minutes, three times per week for eight weeks, while the control group continued their usual school activities. Weekly internet use and perceived stress were assessed before and after the intervention. The study evaluated whether participation in traditional children's games could reduce internet use and perceived stress and support school-based health promotion led by nurses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

August 28, 2023

Last Update Submit

July 9, 2026

Conditions

Keywords

stressinternettraditional children's games

Outcome Measures

Primary Outcomes (2)

  • Weekly Internet Use Duration

    Weekly internet use duration (hours/week) reported by parents using the Descriptive Characteristics Form

    Baseline and Week 8 (immediately after the intervention)

  • Perceived Stress Scale for Children Total Score

    Perceived stress assessed using the Turkish version of the Perceived Stress Scale for Children (8-11 years). Total scores range from 9 to 36, with higher scores indicating higher perceived stress.

    Baseline and Week 8 (immediately after the intervention)

Study Arms (2)

İntervention Group

EXPERIMENTAL

Participants in the intervention group received a nurse-led traditional children's games program conducted as an extracurricular school-based activity. The program consisted of 60-minute sessions, three times per week for eight weeks. Age-appropriate traditional Turkish children's games involving physical activity, teamwork, cooperation, and social interaction were implemented under the supervision of the researcher. Games were selected from the Traditional Children's Games Festival Guide published by the Turkish Ministry of National Education and the Ministry of Youth and Sports.

Behavioral: Nurse-Led Traditional Children's Games Program

Control Group

ACTIVE COMPARATOR

Participants continued their usual school curriculum, including regular physical education classes, without receiving the traditional children's games program.

Behavioral: Usual School Activities

Interventions

Participants received a nurse-led traditional children's games program consisting of 60-minute sessions, three times per week for eight weeks. The intervention included age-appropriate traditional Turkish children's games conducted as an extracurricular school-based activity under researcher supervision.

Also known as: Questionnaire (Including Internet Usage Time,Child Perceived Stress Scale )
İntervention Group

Participants continued their usual school curriculum, including regular physical education classes, and did not receive the traditional children's games program.

Also known as: Questionnaire (Including Internet Usage Time, Child Perceived Stress Scale)
Control Group

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students enrolled in the 5th or 6th grade.
  • Aged 10-12 years.
  • Daily internet use of more than 2 hours.
  • Written informed consent obtained from a parent or legal guardian.
  • Child assent obtained before participation.

You may not qualify if:

  • Having a physical, orthopedic, or mental illness or disability that could interfere with participation in the intervention.
  • Regular participation in organized sports activities or sporting events.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the behavioral intervention, participants and the intervention provider could not be blinded. However, data entry, statistical analyses, and reporting were performed by an independent statistician blinded to group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in parallel to either a traditional children's games intervention group or a control group receiving usual school activities. Outcomes were assessed before and after the 8-week intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lecturer

Study Record Dates

First Submitted

August 28, 2023

First Posted

October 13, 2023

Study Start

October 23, 2022

Primary Completion

February 22, 2023

Study Completion

February 22, 2023

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations