Digital TechnologyDigital HabitsNCT07032090
The Effect of Health Education Based Laughter Yoga Applied to Adolescents on Stress and Digital Gaming Habits
A study testing Health education and Laughter Yoga in people with Digital Technology and Technology Addiction, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Digital Technology, Technology Addiction, Internet Addiction Disorder
- What is being tested?
- Health education and Laughter Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gulhane Faculty of Nursing
Ankara
About this study
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.
Read the detailed description
This study is designed as a four-arm randomized controlled trial using the Solomon design. It aims to evaluate the effects of health education and laughter yoga on adolescents' stress levels and digital gaming habits. The intervention will be conducted during April-May 2025 with middle school students enrolled in grades 5 through 8.
The study sample will include 68 volunteer students who meet the inclusion criteria and provide parental consent. Participants will be assigned to four groups using stratified simple randomization: Intervention I, Intervention II, Control I, and Control II.
- Intervention I Group: Participants will complete a pre-test, receive a single-session health education on stress and coping, followed by laughter yoga sessions conducted twice weekly for six weeks (total of 12 sessions). A post-test will be administered at the end.
- Intervention II Group: Participants will receive the same health education and laughter yoga intervention without a pre-test. Post-test will be conducted after the sessions.
- Control I Group: Participants will complete the pre-test but will not receive any intervention during the study. A post-test will be applied at the end of the study, followed by an optional laughter yoga session.
- Control II Group: Participants will not complete a pre-test or receive any intervention. A post-test will be administered at the end of the study, followed by an optional laughter yoga session.
The assessment tools include the "Digital Game Addiction Scale for Children" and the "Adolescent Stress Questionnaire - Short Form." At the end of the intervention, participant satisfaction will also be assessed using group-specific satisfaction questionnaires.
Data analysis will involve descriptive statistics (frequency, percentage, mean, standard deviation) and appropriate inferential tests based on the distribution of the data. Parametric or non-parametric tests will be used as applicable. Linear models will assess the main effects of group and time, as well as the interaction between them. The significance level will be set at p<0.05.
This research is expected to contribute to school-based public health interventions by evaluating a combined strategy involving health education and a non-pharmacological stress management technique (laughter yoga) among adolescents.
- Being tested
- Health education, Laughter Yoga
- Keywords
- Laughter Yoga, Digital Technology, Technology Addiction, Internet Addiction Disorder, Adolescent, Stress, Health Education
- Medical subject headings
- Technology Addiction, Internet Addiction Disorder, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
Also called stress coping training
Participants will receive face-to-face health education, followed by 12 sessions of laughter yoga.
Laughter YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health education; Behavioral: 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. Receives: Behavioral: Health education; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start15 Mar 2025
- Primary completion25 May 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A four-arm randomized controlled study using the Solomon design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Özdemir, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032090
- Sponsor's protocol ID
- 2025/98
- Acronym
- Digital Habits
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education Based Laughter Yoga Applied to Adolescents on Stress and Digital Gaming Habits
- ClinicalTrials.gov ID
- NCT07032090
- Acronym / sponsor ID
- Digital Habits / 2025/98
- Keywords
- Laughter Yoga, Digital Technology, Technology Addiction, Internet Addiction Disorder, Adolescent, Stress, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed as a four-arm randomized controlled trial using the Solomon design. It aims to evaluate the effects of health education and laughter yoga on adolescents' stress levels and digital gaming habits. The intervention will be conducted during April-May 2025 with middle school students enrolled in grades 5 through 8.
The study sample will include 68 volunteer students who meet the inclusion criteria and provide parental consent. Participants will be assigned to four groups using stratified simple randomization: Intervention I, Intervention II, Control I, and Control II.
- Intervention I Group: Participants will complete a pre-test, receive a single-session health education on stress and coping, followed by laughter yoga sessions conducted twice weekly for six weeks (total of 12 sessions). A post-test will be administered at the end.
- Intervention II Group: Participants will receive the same health education and laughter yoga intervention without a pre-test. Post-test will be conducted after the sessions.
- Control I Group: Participants will complete the pre-test but will not receive any intervention during the study. A post-test will be applied at the end of the study, followed by an optional laughter yoga session.
- Control II Group: Participants will not complete a pre-test or receive any intervention. A post-test will be administered at the end of the study, followed by an optional laughter yoga session.
The assessment tools include the "Digital Game Addiction Scale for Children" and the "Adolescent Stress Questionnaire - Short Form." At the end of the intervention, participant satisfaction will also be assessed using group-specific satisfaction questionnaires.
Data analysis will involve descriptive statistics (frequency, percentage, mean, standard deviation) and appropriate inferential tests based on the distribution of the data. Parametric or non-parametric tests will be used as applicable. Linear models will assess the main effects of group and time, as well as the interaction between them. The significance level will be set at p<0.05.
This research is expected to contribute to school-based public health interventions by evaluating a combined strategy involving health education and a non-pharmacological stress management technique (laughter yoga) among adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- A four-arm randomized controlled study using the Solomon design.
| Arm | Type | Receives |
|---|---|---|
| Arm 1:Health Education and Laughter Yoga | Experimental | Behavioral: Health education, Behavioral: Laughter YogaParticipants 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. |
| Arm 3: Health Education and Laughter Yoga | Experimental | Behavioral: Health education, Behavioral: Laughter YogaParticipants 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. |
| 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health educationAlso: stress coping trainingParticipants will receive face-to-face health education, followed by 12 sessions of laughter yoga. | Behavioural | Arm 1:Health Education and Laughter Yoga, Arm 3: Health Education and Laughter Yoga |
| Laughter YogaThe 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. | Behavioural | Arm 1:Health Education and Laughter Yoga, Arm 3: Health Education and Laughter Yoga |
Primary outcome
Digital Game Addiction Scale for Children
Time frame: 1.5 months
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.
Adolescent Stress Questionnaire -Short Form
Time frame: 1.5 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education and Laughter Yoga in people with Digital Technology and Technology Addiction, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Game Addiction Scale for Children (time frame: 1.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.