- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534566
Evaluation of the Effect of a PRECEDE-PROCEED Model-Based "Laughter Yoga-Supported Education Program" on Peer Bullying (Peer Bullying)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Mamak
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Ankara, Mamak, Turkey (Türkiye)
- Ankara University. Nursing Fakulty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Arm 2: Control Group
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.
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Experimental: Intervention Group 1 Health Education and Laughter Yoga
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.
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Participants will receive face-to-face health education over 6 weeks,
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
1 month
|
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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 |
1.5 months
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Peer Bullying Knowledge Form
Time Frame: 1.5
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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.
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1.5
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Laughter Yoga-Supported Education Program Evaluation Questionnaire
Time Frame: 1.5 month
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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.
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1.5 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21/266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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