- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Pamukkale
-
Denizli, Pamukkale, Turecko (Türkiye), 20070
- Public Secondary Schools
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Žádný zásah: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Test Anxiety (Westside Test Anxiety Scale score)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Health-Related Quality of Life (PedsQL 13-18 Adolescent Form score)
Časové okno: 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)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- NSM-YT-2026
- E-60116787-020-704556 (Jiný identifikátor: Pamukkale University Non-Interventional Clinical Research Ethics Committee)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Test Anxiety in Adolescents
-
Ramsay Générale de SantéEuropean Clinical Trial Experts Network; Private hospital Parly IINáborin vitro oplodnění | Test přežití lidských spermií | EmbryotoxicitaFrancie
-
Huashan HospitalZhejiang Cancer Hospital; Shanghai Zhongshan Hospital; Tongji Hospital; Qilu Hospital... a další spolupracovníciNáborSpinocelulární karcinom hlavy a krku | Organoid odvozený od pacienta | Test citlivosti na léčivo in vitroČína
-
Huashan HospitalZhejiang Cancer Hospital; Qilu Hospital of Shandong University; Second Affiliated... a další spolupracovníciNáborRakoviny slinných žláz | Organoid odvozený od pacienta | Test citlivosti na léčivo in vitroČína
-
National Cancer Institute (NCI)DokončenoEndometrioidní adenokarcinom vaječníků | Adenokarcinom slinivky břišní | Recidivující rakovina slinivky břišní | Rakovina slinivky břišní ve stádiu III | Rakovina slinivky břišní ve stádiu IV | Mužská rakovina prsu | Rakovina prsu ve stádiu IV | Rakovina prsu stadia IIIA | Stádium IIIB rakoviny prsu | Recidivující... a další podmínkySpojené státy
Klinické studie na School-Based Yoga Therapy Program
-
Ministry of Health, MalaysiaDokončeno
-
McGill UniversityObservatory for Children's Education and HealthZatím nenabíráme
-
University of MinhoDokončenoObezita | Podpora zdraví | Vývoj dítěte | Nepřenosné nemoci | Životní stylPortugalsko
-
Hannover Medical SchoolAktivní, ne nábor
-
The University of QueenslandRestorative Outcomes Australia; Department of Education, Queensland; Queensland... a další spolupracovníciNeznámýAntisociální chování | Školní docházka | Závislost na blahobytuAustrálie
-
Global Institute of Human DevelopmentNational Institute of Mental Health (NIMH)Aktivní, ne náborDeprese, úzkost | Úzkost, emocionální | Psychosociální problém | Funkční, psychosociálníPákistán
-
University of TromsoUniversity of Bergen; Norwegian University of Science and Technology; UiT The... a další spolupracovníciDokončenoDeprese, úzkost | Školní fobie | Absence | Záškoláctví; SocializovanýNorsko
-
Columbia UniversityNational Institute on Aging (NIA)Dokončeno
-
University of CatanzaroDokončeno
-
Kaiser PermanenteUniversity of California, San Diego; National Institute on Minority Health... a další spolupracovníciNábor