NCT07032090

Brief Summary

Adolescents may turn to digital games as a coping mechanism for stress, which can lead to addiction and various health problems. School-based health education and laughter yoga are promising interventions for reducing stress and promoting healthy behaviors. This randomized controlled trial with a Solomon four-group design aims to evaluate the effects of health education and laughter yoga on stress levels and digital game habits among adolescents. Study Hypotheses: H0-1: Health education and laughter yoga have no effect on adolescent stress. H1-1: Health education and laughter yoga reduce adolescent stress. H0-2: Health education and laughter yoga do not affect digital game habits. H1-2: Health education and laughter yoga reduce digital game habits.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

March 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 13, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

Laughter YogaDigital TechnologyTechnology AddictionInternet Addiction DisorderAdolescentStressHealth Education

Outcome Measures

Primary Outcomes (2)

  • Digital Game Addiction Scale for Children

    It was developed by Hazar and Hazar (2017) to determine the levels of digital game addiction in children aged 10-14. The scale, prepared as a 5-point Likert type, consists of 4 sub-factors and 24 items. Each item on the scale is coded as "1 = Strongly Disagree," "2 = Disagree," "3 = Neutral," "4 = Agree," and "5 = Strongly Agree." The lowest possible score on the scale is 24, and the highest is 120. The scoring classification is as follows: "1-24: Normal group, 25-48: Low-risk group, 49-72: Risk group, 73-96: Addicted group, 97-120: Highly addicted group." The sub-dimensions of the scale are: "Excessive Focus and Conflict Related to Digital Gaming," "Tolerance Development in Game Time and Value Assigned to the Game," "Postponement of Individual and Social Tasks/Homework," and "Psychological-Physiological Reflection of Withdrawal and Immersion in the Game." The Cronbach's alpha for the entire scale is 0.90, and for the sub-factors, it is 0.78, 0.81, 0.76, and 0.67, respectively.

    1.5 months

  • Adolescent Stress Questionnaire -Short Form

    The Adolescent Stress Questionnaire was developed by Byrne et al. in 2007 as a 5-point Likert-type scale consisting of 58 items and 10 subscales. In 2018, Anniko et al. created a shortened version of the questionnaire with 27 items and 9 subscales. The Turkish validity and reliability study of the scale was conducted by Öztürk Tanış and Gür in 2022. The questionnaire asks participants to evaluate the degree to which each item represents a source of stress for them. Each item is rated on a scale from: "1 = Not at all stressful (or did not occur)," "2 = A little stressful," "3 = Moderately stressful," "4 = Quite stressful," "5 = Very stressful." Higher scores indicate higher levels of perceived stress. The Cronbach's alpha for the original version of the scale is 0.93. For the Turkish version, the overall Cronbach's alpha is 0.88, and the subscale alphas range from 0.62 to 0.88.

    1.5 month

Study Arms (4)

Arm 1:Health Education and Laughter Yoga

EXPERIMENTAL

Participants will complete a pre-test, receive a single face-to-face session of stress management education, followed by laughter yoga twice a week for 6 weeks.

Behavioral: Health educationBehavioral: Laughter Yoga

Arm 3: Health Education and Laughter Yoga

EXPERIMENTAL

Participants will receive a single face-to-face session of stress management education without a pre-test, followed by laughter yoga twice a week for 6 weeks.

Behavioral: Health educationBehavioral: Laughter Yoga

Arm 2: Control Group

NO INTERVENTION

Participants will undergo a pre-test with no additional intervention; post-tests will be conducted at the end of the study, and laughter yoga will be offered to volunteers.

Arm 4: Control Group

NO INTERVENTION

Participants will not undergo a pre-test and no additional intervention will be provided; post-tests will be conducted at the end of the study, and laughter yoga will be offered to volunteers.

Interventions

Participants will receive face-to-face health education, followed by 12 sessions of laughter yoga.

Also known as: stress coping training
Arm 1:Health Education and Laughter YogaArm 3: Health Education and Laughter Yoga
Laughter YogaBEHAVIORAL

The intervention groups will receive a total of 12 sessions of laughter yoga, delivered by the researcher over 6 weeks, twice a week, each lasting 40-45 minutes.

Arm 1:Health Education and Laughter YogaArm 3: Health Education and Laughter Yoga

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents who are students in the 5th, 6th, 7th, and 8th grades,
  • whose parents and themselves volunteer to participate in the study,
  • who play digital games using devices such as mobile phones, tablets, computers, or game consoles will be included in the study.

You may not qualify if:

  • Adolescents who have any health condition that prevents them from exercising; -who have undergone abdominal surgery within the last three months; or
  • who have diabetes, glaucoma, hypertension, epilepsy, asthma,
  • hernia will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University Gulhane Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Technology AddictionInternet Addiction DisorderHealth Education

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: A four-arm randomized controlled study using the Solomon design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 22, 2025

Study Start

March 15, 2025

Primary Completion

May 25, 2025

Study Completion

September 15, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations