- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07644182
Neuman Systems Model-Based Yoga Therapy for Test Anxiety in Secondary School Students
The Effect of a Yoga Therapy Program Grounded in the Neuman Systems Model on Test Anxiety, Quality of Life, and Mindfulness Among Secondary School Students: A Cluster Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This cluster randomized controlled trial was designed to evaluate the effects of a yoga therapy program grounded in Neuman Systems Model on test anxiety, quality of life, and mindfulness levels among 13-14-year-old middle school students. The target population consisted of eighth-grade students attending schools in the central districts of Denizli province, Türkiye. In Türkiye, eighth-grade students prepare for the nationwide High School Entrance System (LGS) examination and may experience high academic pressure and test anxiety. Therefore, the study was conducted with eighth-grade students.
The inclusion criteria were defined as being an eighth-grade student, having no physical or mental disability, agreeing to participate voluntarily in the study, and providing parental consent. Students with prior regular yoga experience were excluded to minimize potential confounding factors that could influence the effects of the intervention.
Among 68 public middle schools in the central districts of Denizli, 27 schools that agreed to participate constituted the study pool. From this pool, two schools meeting the eligibility criteria were selected using simple random sampling. Each school was considered a cluster. The selected schools were then allocated to intervention and control groups by an independent researcher using a simple randomization method. Following randomization, two classes were randomly selected from seven eighth-grade classes in the intervention school, and two classes were randomly selected from nine eighth-grade classes in the control school. Cluster randomization at the school level was employed to minimize contamination due to potential information exchange between intervention and control groups.
The sample size was calculated using G*Power version 3.1.9.4. The calculation was based on a study design involving two groups and three measurement time points. A repeated-measures analysis of variance (ANOVA) was used with a medium effect size (f = 0.25), a significance level of 0.05, and a statistical power of 0.95. The minimum required sample size was determined to be 142 students. Considering potential attrition, it was planned to include 80 students in each group, for a total of 160 students. Ultimately, the study sample consisted of 166 students, with 81 in the intervention group and 85 in the control group.
The yoga therapy program was developed in collaboration with the researcher, who is certified in children's yoga, and two certified yoga experts with experience in adult yoga, children's yoga, and mindfulness-based practices. The intervention was delivered jointly by the researcher and one of the certified yoga instructors. The program was conducted over four weeks, with one 40-minute session per week. Each session consisted of breathing awareness and intention setting (5 minutes), warm-up exercises (5 minutes), yoga postures aimed at improving attention, balance, strength, and self-confidence (15 minutes), pranayama practices designed to reduce anxiety and enhance focus (5 minutes), and relaxation with mindfulness-based meditation (10 minutes).
Outcome variables were assessed using the Westside Test Anxiety Scale for test anxiety, the Quality of Life Scale for Children and Adolescents (13-18 years version) for quality of life, the BAU Mindfulness Scale for Children for mindfulness levels, and a researcher-developed Student Information Form for demographic characteristics. Data were collected at three time points: baseline assessment before the first intervention session, mid-assessment after the second session, and post-assessment after the fourth session.
The study was approved by the Non-Interventional Clinical Research Ethics Committee of Pamukkale University and conducted with the necessary institutional permissions from the Ministry of National Education. Participation was voluntary, and written informed consent was obtained from parents or legal guardians of all participating students.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pamukkale
-
Denizli, Pamukkale, Turquía (Türkiye), 20070
- Public Secondary Schools
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Being enrolled as a secondary school student
- Aged 13-14 years
- Willing to participate in the study
- Having parental consent and student assent
Exclusion Criteria:
- Any physical or mental condition that interferes with participation in yoga-based activities
- Previous regular experience with yoga or mindfulness practice
- Absence during the intervention period or inability to complete study procedures
- Refusal to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: School-Based Yoga Therapy Group
Participants in the experimental group received a school-based yoga therapy program developed in line with Neuman Systems Model.
The intervention included structured yoga sessions focusing on breathing exercises, physical postures, relaxation techniques, and mindfulness practices.
Sessions were delivered by the researcher during school hours for a specified intervention period.
The aim of the program was to reduce test anxiety and improve mindfulness and quality of life among secondary school students.
|
Participants received a structured school-based yoga intervention based on the Neuman Systems Model, including breathing exercises, physical postures, relaxation, and mindfulness practices.
The intervention was delivered during school hours in structured sessions over a defined intervention period.
The aim was to reduce test anxiety and improve mindfulness and quality of life among secondary school students.
|
|
Sin intervención: Control Group
Participants in the control group received no additional intervention beyond the routine school curriculum.
No yoga, mindfulness, or relaxation-based activities were implemented for this group during the study period.
The group functioned as a no-intervention control condition for outcome comparison.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Test Anxiety (Westside Test Anxiety Scale score)
Periodo de tiempo: Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
|
Measured using the Westside Test Anxiety Scale (WSKÖ) to assess changes in students' exam-related anxiety levels in a school-based yoga intervention.
|
Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health-Related Quality of Life (PedsQL 13-18 Adolescent Form score)
Periodo de tiempo: Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
|
Measured using the Pediatric Quality of Life Inventory (PedsQL) Adolescent Form to evaluate changes in perceived quality of life among secondary school students receiving the intervention.
|
Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
|
|
Mindfulness Level (BAU Child and Adolescent Mindfulness Scale score)
Periodo de tiempo: Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
|
Measured using the BAU Child Mindfulness Scale (BAU-CMÖ) to assess changes in mindfulness and present-moment awareness in adolescents participating in the yoga intervention.
|
Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Khalsa SB, Hickey-Schultz L, Cohen D, Steiner N, Cope S. Evaluation of the mental health benefits of yoga in a secondary school: a preliminary randomized controlled trial. J Behav Health Serv Res. 2012 Jan;39(1):80-90. doi: 10.1007/s11414-011-9249-8.
- Khunti K, Boniface S, Norris E, De Oliveira CM, Nicola Shelton. The effects of yoga on mental health in school-aged children: A Systematic Review and Narrative Synthesis of Randomised Control Trials. Clin Child Psychol Psychiatry. 2023 Jul;28(3):1217-1238. doi: 10.1177/13591045221136016. Epub 2022 Oct 27.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NSM-YT-2026
- E-60116787-020-704556 (Otro identificador: Pamukkale University Non-Interventional Clinical Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .