Laughter YogaPeer BullyingNCT07534566
Evaluation of the Effect of a PRECEDE-PROCEED Model-Based "Laughter Yoga-Supported Education Program" on Peer Bullying
A study testing Health education and Laughter Yoga in people with Laughter Yoga and Peer Bullying, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Adolescence is a critical developmental period marked by rapid cognitive, emotional, and social changes that shape personality and psychosocial functioning. During this stage, peer relationships play a central role in adolescents' mental well-being, academic performance, and social adjustment. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga, Peer Bullying, Adolescents
- 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
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2026to 30 Mar 2026
- 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
- Voluntary participation of the student and parent/guardian
- Being enrolled as an 8th-grade student
- No hearing, visual, or cognitive impairment affecting participation in data collection
Who cannot join
- Presence of any medical condition contraindicating physical activity
- History of abdominal surgery within the past 3 months
- Diagnosis of diabetes, glaucoma, hypertension, epilepsy, hernia, or asthma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University. Nursing Fakulty
Ankara, Mamak
About this study
Adolescence is a critical developmental period marked by rapid cognitive, emotional, and social changes that shape personality and psychosocial functioning. During this stage, peer relationships play a central role in adolescents' mental well-being, academic performance, and social adjustment. However, unhealthy peer interactions and exposure to peer bullying significantly increase the risk of adverse physical, psychological, and social outcomes, including anxiety, depression, low self-esteem, academic difficulties, and risky health behaviors, making bullying a major public health concern.
Recent evidence indicates a rising prevalence of peer bullying, particularly among middle school students, highlighting the need for effective school-based interventions. Previous programs have demonstrated reductions in bullying behaviors and improvements in school adjustment and self-confidence, yet meta-analytic findings suggest that existing educational interventions have limited effectiveness, underscoring the need for innovative and theory-driven approaches.
Read more
The PRECEDE-PROCEED Model offers a comprehensive framework for designing sustainable health promotion interventions by addressing predisposing, enabling, and reinforcing factors influencing behavior. In this context, a laughter yoga-supported education program grounded in this model aims to increase adolescents' awareness of peer bullying, enhance physiological, psychological, and social well-being, strengthen social interaction, and improve quality of life. To date, no studies have examined the effects of a PRECEDE-PROCEED Model-based laughter yoga intervention on peer bullying. The aim of this study is to examine the effect of the "Laughter Yoga-Supported Education Program," developed based on the PRECEDE-PROCEED Model, on peer bullying among adolescents.
Objectives:
To improve adolescents' levels of awareness regarding peer bullying through the PRECEDE-PROCEED Model-based "Laughter Yoga-Supported Education Program," To enhance adolescents' awareness of health behaviors related to peer bullying through the PRECEDE-PROCEED Model-based "Laughter Yoga-Supported Education Program," To develop adolescents' social skills through PRECEDE-PROCEED Model-based laughter yoga educational practices, To significantly reduce the post-test mean peer bullying scores of adolescents in the intervention group compared with their pre-test mean scores, To ensure that the findings of the study contribute to the literature and guide future research on PRECEDE-PROCEED Model-based interventions.
Hypotheses:
H0-1: There is no significant difference in Peer Bullying Identification Scale scores between adolescents who receive the PRECEDE-PROCEED Model-based Laughter Yoga-Supported Education Program and those who do not.
H1-1: There is a significant difference in Peer Bullying Identification Scale scores between adolescents who receive the PRECEDE-PROCEED Model-based Laughter Yoga-Supported Education Program and those who do not.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effects of a PRECEDE-PROCEED Model-based laughter yoga-supported education program on peer bullying, empathy, and related knowledge among 8th-grade students in a middle school located in the Altındağ district of Ankara, Türkiye.
The study population consists of 8th-grade students enrolled in a randomly selected middle school in a socioeconomically disadvantaged district. Participants who meet the inclusion criteria and provide parental consent will be randomly assigned to intervention and control groups using a simple random allocation method to ensure equal probability of group assignment and minimize selection bias.
The intervention group will receive a 6-week structured program based on the PRECEDE-PROCEED Model, consisting of weekly theoretical education sessions (30-40 minutes) on peer bullying and health-related outcomes, and laughter yoga sessions (40-45 minutes) conducted twice per week by a certified instructor. Educational materials will also be shared with families to reinforce learning. The control group will receive no intervention during the study period.
Data will be collected at three time points: baseline (pre-test), immediately after the 6-week intervention (post-test), and 3-month follow-up. Outcome measures include peer bullying behaviors, peer bullying knowledge, and empathy and sympathy levels, assessed using validated measurement tools.
After completion of the study, a single-session educational intervention will be provided to the control group for ethical considerations.
Data will be analyzed using SPSS software. Descriptive statistics will be calculated, and group comparisons will be performed using independent samples t-test, ANOVA, and non-parametric equivalents where appropriate. Statistical significance will be set at p < 0.05.
- Being tested
- Health education, Laughter Yoga
- Keywords
- PRECEDE-PROCEED Model, Laughter Yoga, Peer bullying, Adolescents, Social skills
- Medical subject headings
- Health Education, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
Participants will receive face-to-face health education over 6 weeks,
Laughter YogaBehavioural
The intervention groups will receive a total of 6 sessions of laughter yoga, delivered by the researcher over 6 weeks, once a week, each lasting 40-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1 Health Education and Laughter Yoga | Experimental | Participants will complete a pre-test,Each week, one day will be allocated to health education, during which students will receive 30-40 minutes of theoretical instruction and informational brochures will be distributed to families. On the other day, students will participate in a 40-45 minute laughter yoga session conducted by a researcher certified in laughter yoga. 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Empathy and Sympathy Scale
This scale, developed by Vossen et al. (2015), was designed to assess levels of empathy and sympathy in adolescents, to distinguish between these two constructs, and to address cognitive and emotional empathy dimensions equally (Vossen et al., 2015). The Turkish adaptation, validity, and reliability study was conducted by Zengin et al. (2018).
The scale is rated on a 5-point Likert type and consists of a total of 12 items across three subscales: cognitive empathy, emotional empathy, and sympathy. Each subscale includes four items; the first four items measure emotional empathy, the next four measure cognitive empathy, and the final four measure sympathy. Higher scores indicate higher levels of empathy or sympathy, while lower scores indicate lower levels.
Cronbach's alpha reliability coefficients for the subscales were reported as 0.63 for cognitive empathy, 0.63 for emotional empathy, and 0.75 for the sympathy subscale (Zengin et al., 2018). P
Measured: 1 month
Peer Bullying Scale
The Peer Bullying Scale was developed by Mynard and Joseph (2000). Its Turkish validity and reliability study was conducted by Gültekin and Sayıl (2005). The scale used in this study consists of five subdimensions and a total of 27 items. The subdimensions are defined as Intimidation/Threat, Teasing, Physical Aggression, Relational Aggression, and Attacks on Personal Property. The items are rated on a 3-point Likert scale as "more than once" (2 points), "once" (1 point), and "never" (0 points). The total score ranges from 0 to 54. The Cronbach's alpha coefficient for the overall scale is 0.86, and for the subscales, the values are 0.73, 0.68, 0.72, 0.72, and 0.67, respectively (Gültekin \& Sayıl, 2005). The scale identifies victims of bullying. Higher scores indicate more frequent experiences of peer bullying, whereas lower scores indicate fewer or no such experiences.
Pekel and Uçanok (2005) adapted this scale by adding the question, "How often do you engage in t
Measured: 1.5 months
Peer Bullying Knowledge Form
The form was developed by Yavuz and Özdemir in 2024. It was designed to assess middle school students' knowledge levels regarding peer bullying before and after the educational intervention. The form consists of eight items, each rated on a 3-point Likert scale ("I don't know = 0," "incorrect = 1," "correct = 2"). Total scores range from 0 to 16, with higher scores indicating increased knowledge about peer bullying. To evaluate content and language validity, expert opinions were obtained from six specialists and analyzed using the Content Validity Index (CVI) method. The calculated CVI value was 0.95. In addition, the reliability of the form was examined, and the Cronbach's alpha internal consistency coefficient was found to be 0.85 (Yavuz \& Çevik Özdemir, 2024). Permission to use the scale in this study was obtained from the corresponding author and is included in the appendix.
Measured: 1.5
Laughter Yoga-Supported Education Program Evaluation Questionnaire
The questionnaire designed to evaluate the Laughter Yoga-Supported Education Program was developed by the researcher. This form consists of 15 items aimed at assessing participants' satisfaction with the program implemented during the study and identifying any problems encountered.
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 posted16 Apr 2026
- Study start3 Feb 2026
- Primary completion13 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laughter YogaStudies 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
- The study was planned as a randomized controlled experimental design with a pretest-posttest.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahsa Tamaddon, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534566
- Sponsor's protocol ID
- 21/266
- Acronym
- Peer Bullying
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tamaddon M, Ozturk Eyimaya A, Tezel A. Effect of a PRECEDE-PROCEED model-based laughter yoga-supported education program on adolescent bullying: A randomized controlled trial. J Pediatr Nurs. 2026 Oct 23:S0882-5963(26)00519-1. doi: 10.1016/j.pedn.2026.10.012. Online ahead of print.
PubMed 42919689
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
- Evaluation of the Effect of a PRECEDE-PROCEED Model-Based "Laughter Yoga-Supported Education Program" on Peer Bullying
- ClinicalTrials.gov ID
- NCT07534566
- Acronym / sponsor ID
- Peer Bullying / 21/266
- Keywords
- PRECEDE-PROCEED Model, Laughter Yoga, Peer bullying, Adolescents, Social skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 16 Apr 2026 (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.
Adolescence is a critical developmental period marked by rapid cognitive, emotional, and social changes that shape personality and psychosocial functioning. During this stage, peer relationships play a central role in adolescents' mental well-being, academic performance, and social adjustment. However, unhealthy peer interactions and exposure to peer bullying significantly increase the risk of adverse physical, psychological, and social outcomes, including anxiety, depression, low self-esteem, academic difficulties, and risky health behaviors, making bullying a major public health concern.
Recent evidence indicates a rising prevalence of peer bullying, particularly among middle school students, highlighting the need for effective school-based interventions. Previous programs have demonstrated reductions in bullying behaviors and improvements in school adjustment and self-confidence, yet meta-analytic findings suggest that existing educational interventions have limited effectiveness, underscoring the need for innovative and theory-driven approaches.
The PRECEDE-PROCEED Model offers a comprehensive framework for designing sustainable health promotion interventions by addressing predisposing, enabling, and reinforcing factors influencing behavior. In this context, a laughter yoga-supported education program grounded in this model aims to increase adolescents' awareness of peer bullying, enhance physiological, psychological, and social well-being, strengthen social interaction, and improve quality of life. To date, no studies have examined the effects of a PRECEDE-PROCEED Model-based laughter yoga intervention on peer bullying. The aim of this study is to examine the effect of the "Laughter Yoga-Supported Education Program," developed based on the PRECEDE-PROCEED Model, on peer bullying among adolescents.
Objectives:
To improve adolescents' levels of awareness regarding peer bullying through the PRECEDE-PROCEED Model-based "Laughter Yoga-Supported Education Program," To enhance adolescents' awareness of health behaviors related to peer bullying through the PRECEDE-PROCEED Model-based "Laughter Yoga-Supported Education Program," To develop adolescents' social skills through PRECEDE-PROCEED Model-based laughter yoga educational practices, To significantly reduce the post-test mean peer bullying scores of adolescents in the intervention group compared with their pre-test mean scores, To ensure that the findings of the study contribute to the literature and guide future research on PRECEDE-PROCEED Model-based interventions.
Hypotheses:
H0-1: There is no significant difference in Peer Bullying Identification Scale scores between adolescents who receive the PRECEDE-PROCEED Model-based Laughter Yoga-Supported Education Program and those who do not.
H1-1: There is a significant difference in Peer Bullying Identification Scale scores between adolescents who receive the PRECEDE-PROCEED Model-based Laughter Yoga-Supported Education Program and those who do not.
Detailed description
This study is a randomized controlled trial designed to evaluate the effects of a PRECEDE-PROCEED Model-based laughter yoga-supported education program on peer bullying, empathy, and related knowledge among 8th-grade students in a middle school located in the Altındağ district of Ankara, Türkiye.
The study population consists of 8th-grade students enrolled in a randomly selected middle school in a socioeconomically disadvantaged district. Participants who meet the inclusion criteria and provide parental consent will be randomly assigned to intervention and control groups using a simple random allocation method to ensure equal probability of group assignment and minimize selection bias.
The intervention group will receive a 6-week structured program based on the PRECEDE-PROCEED Model, consisting of weekly theoretical education sessions (30-40 minutes) on peer bullying and health-related outcomes, and laughter yoga sessions (40-45 minutes) conducted twice per week by a certified instructor. Educational materials will also be shared with families to reinforce learning. The control group will receive no intervention during the study period.
Data will be collected at three time points: baseline (pre-test), immediately after the 6-week intervention (post-test), and 3-month follow-up. Outcome measures include peer bullying behaviors, peer bullying knowledge, and empathy and sympathy levels, assessed using validated measurement tools.
After completion of the study, a single-session educational intervention will be provided to the control group for ethical considerations.
Data will be analyzed using SPSS software. Descriptive statistics will be calculated, and group comparisons will be performed using independent samples t-test, ANOVA, and non-parametric equivalents where appropriate. Statistical significance will be set at p < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled experimental design with a pretest-posttest.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1 Health Education and Laughter Yoga | Experimental | Behavioral: Health education, Behavioral: Laughter YogaParticipants will complete a pre-test,Each week, one day will be allocated to health education, during which students will receive 30-40 minutes of theoretical instruction and informational brochures will be distributed to families. On the other day, students will participate in a 40-45 minute laughter yoga session conducted by a researcher certified in 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Voluntary participation of the student and parent/guardian
- Being enrolled as an 8th-grade student
- No hearing, visual, or cognitive impairment affecting participation in data collection
Key exclusion criteria (3 listed)
- Presence of any medical condition contraindicating physical activity
- History of abdominal surgery within the past 3 months
- Diagnosis of diabetes, glaucoma, hypertension, epilepsy, hernia, or asthma
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 educationParticipants will receive face-to-face health education over 6 weeks, | Behavioural | Intervention Group 1 Health Education and Laughter Yoga |
| Laughter YogaThe intervention groups will receive a total of 6 sessions of laughter yoga, delivered by the researcher over 6 weeks, once a week, each lasting 40-45 minutes. | Behavioural | Intervention Group 1 Health Education and Laughter Yoga |
Primary outcome
Adolescent Empathy and Sympathy Scale
Time frame: 1 month
This scale, developed by Vossen et al. (2015), was designed to assess levels of empathy and sympathy in adolescents, to distinguish between these two constructs, and to address cognitive and emotional empathy dimensions equally (Vossen et al., 2015). The Turkish adaptation, validity, and reliability study was conducted by Zengin et al. (2018). The scale is rated on a 5-point Likert type and consists of a total of 12 items across three subscales: cognitive empathy, emotional empathy, and sympathy. Each subscale includes four items; the first four items measure emotional empathy, the next four measure cognitive empathy, and the final four measure sympathy. Higher scores indicate higher levels of empathy or sympathy, while lower scores indicate lower levels. Cronbach's alpha reliability coefficients for the subscales were reported as 0.63 for cognitive empathy, 0.63 for emotional empathy, and 0.75 for the sympathy subscale (Zengin et al., 2018). P
Peer Bullying Scale
Time frame: 1.5 months
The Peer Bullying Scale was developed by Mynard and Joseph (2000). Its Turkish validity and reliability study was conducted by Gültekin and Sayıl (2005). The scale used in this study consists of five subdimensions and a total of 27 items. The subdimensions are defined as Intimidation/Threat, Teasing, Physical Aggression, Relational Aggression, and Attacks on Personal Property. The items are rated on a 3-point Likert scale as "more than once" (2 points), "once" (1 point), and "never" (0 points). The total score ranges from 0 to 54. The Cronbach's alpha coefficient for the overall scale is 0.86, and for the subscales, the values are 0.73, 0.68, 0.72, 0.72, and 0.67, respectively (Gültekin \& Sayıl, 2005). The scale identifies victims of bullying. Higher scores indicate more frequent experiences of peer bullying, whereas lower scores indicate fewer or no such experiences. Pekel and Uçanok (2005) adapted this scale by adding the question, "How often do you engage in t
Peer Bullying Knowledge Form
Time frame: 1.5
The form was developed by Yavuz and Özdemir in 2024. It was designed to assess middle school students' knowledge levels regarding peer bullying before and after the educational intervention. The form consists of eight items, each rated on a 3-point Likert scale ("I don't know = 0," "incorrect = 1," "correct = 2"). Total scores range from 0 to 16, with higher scores indicating increased knowledge about peer bullying. To evaluate content and language validity, expert opinions were obtained from six specialists and analyzed using the Content Validity Index (CVI) method. The calculated CVI value was 0.95. In addition, the reliability of the form was examined, and the Cronbach's alpha internal consistency coefficient was found to be 0.85 (Yavuz \& Çevik Özdemir, 2024). Permission to use the scale in this study was obtained from the corresponding author and is included in the appendix.
Laughter Yoga-Supported Education Program Evaluation Questionnaire
Time frame: 1.5 month
The questionnaire designed to evaluate the Laughter Yoga-Supported Education Program was developed by the researcher. This form consists of 15 items aimed at assessing participants' satisfaction with the program implemented during the study and identifying any problems encountered.
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.
- Derived from this study: PubMed 42919689Tamaddon M, Ozturk Eyimaya A, Tezel A. Effect of a PRECEDE-PROCEED model-based laughter yoga-supported education program on adolescent bullying: A randomized controlled trial. J Pediatr Nurs. 2026 Oct 23:S0882-5963(26)00519-1. doi: 10.1016/j.pedn.2026.10.012. Online ahead of print.
- 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 Laughter Yoga and Peer Bullying, run by Ankara University 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?
Adolescent Empathy and Sympathy Scale (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07534566, which also lists 1 linked publication.
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.