- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Pamukkale
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Denizli, Pamukkale, Turcja (Türkiye), 20070
- Public Secondary Schools
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Brak interwencji: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Test Anxiety (Westside Test Anxiety Scale score)
Ramy czasowe: Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
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Measured using the Westside Test Anxiety Scale (WSKÖ) to assess changes in students' exam-related anxiety levels in a school-based yoga intervention.
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Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Health-Related Quality of Life (PedsQL 13-18 Adolescent Form score)
Ramy czasowe: Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
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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.
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Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
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Mindfulness Level (BAU Child and Adolescent Mindfulness Scale score)
Ramy czasowe: Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
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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.
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Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- NSM-YT-2026
- E-60116787-020-704556 (Inny identyfikator: Pamukkale University Non-Interventional Clinical Research Ethics Committee)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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