NCT07644182

Brief Summary

This cluster randomized controlled trial evaluates the effects of a yoga therapy program grounded in the Neuman Systems Model on test anxiety, quality of life, and mindfulness among eighth-grade students aged 13-14 years in Denizli, Türkiye. The study was conducted with students preparing for the national High School Entrance System (LGS) examination. A total of 166 eighth-grade students were allocated to intervention and control groups at the school level. The intervention consisted of a structured yoga therapy program delivered once weekly for four weeks. Outcomes were assessed using standardized measures of test anxiety, quality of life, and mindfulness at baseline, mid-intervention, and post-intervention. The study received ethics committee approval, institutional permissions, and written informed consent from parents or legal guardians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

21 days

First QC Date

June 6, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Yoga therapy; Neuman Systems Model; School-based intervention; Cluster randomized controlled trial; Mindfulness; Stress management; Adolescents

Outcome Measures

Primary Outcomes (1)

  • Test Anxiety (Westside Test Anxiety Scale score)

    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)

Secondary Outcomes (2)

  • Health-Related Quality of Life (PedsQL 13-18 Adolescent Form score)

    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)

    Baseline (prior to the first intervention session), Week 2 (after completion of Session 2), and Week 4 (after completion of Session 4)

Study Arms (2)

School-Based Yoga Therapy Group

EXPERIMENTAL

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.

Behavioral: School-Based Yoga Therapy Program

Control Group

NO INTERVENTION

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.

Interventions

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.

School-Based Yoga Therapy Group

Eligibility Criteria

Age13 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being enrolled as a secondary school student
  • Aged 13-14 years
  • Willing to participate in the study
  • Having parental consent and student assent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Secondary Schools

Denizli, Pamukkale, 20070, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 36302735BACKGROUND
  • 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.

    PMID: 21647811BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were assigned to intervention and control groups using cluster randomization at the school level. Two schools were randomly selected from eligible schools and then randomly allocated to either the intervention or control group. The intervention group received a four-week yoga therapy program, while the control group continued their usual school activities. Outcome measures were assessed at baseline, mid-intervention, and post-intervention. Cluster randomization was used to minimize potential contamination between the intervention and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (PhD Student)

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 12, 2026

Study Start

April 30, 2026

Primary Completion

May 21, 2026

Study Completion

May 21, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to ensure participant confidentiality and data protection.

Locations