NCT07534566

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

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

February 3, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

PRECEDE-PROCEED ModelLaughter YogaPeer bullyingAdolescentsSocial skills

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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.

    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.

    1.5 month

Study Arms (2)

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.

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.

Interventions

Participants will receive face-to-face health education over 6 weeks,

Intervention Group 1 Health Education and Laughter Yoga
Laughter YogaBEHAVIORAL

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.

Intervention Group 1 Health Education and Laughter Yoga

Eligibility Criteria

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

You may qualify if:

  • Willingness of both the student and the parent to participate in the study, being an 8th-grade student, and having no hearing, visual, or cognitive impairments that would interfere with completing the data collection forms.

You may not qualify if:

  • Having any health condition that prevents exercise; having undergone abdominal surgery within the last three months; or having diabetes, glaucoma, hypertension, epilepsy, hernia, or asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University. Nursing Fakulty

Ankara, Mamak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health EducationSocial Skills

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSocial 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: The study was planned as a randomized controlled experimental design with a pretest-posttest.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start

February 3, 2026

Primary Completion

March 13, 2026

Study Completion

March 30, 2026

Last Updated

April 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations