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NCT Number: NCT07797595

Human Caring Theory-Based Yoga and Anxiety

This controlled interventional study aims to evaluate the effect of a Human Caring Theory-based yoga program on state anxiety levels in adolescents diagnosed with cancer. Adolescents aged 12-18 years who are receiving outpatient follow-up will be assigned to an intervention group or a control group. The intervention group will participate in an individualized four-week online yoga program delivered through Zoom, comprising two 60-minute sessions per week. The control group will receive no study intervention and will complete the same data collection forms. State anxiety will be assessed using the State Anxiety Inventory (STAI-I). The study will be conducted through the Pediatric Oncology Outpatient Clinic of Akdeniz University Hospital in Antalya, Türkiye.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Adolescents diagnosed with cancer may experience anxiety related to uncertainty, treatment-related adverse effects, social isolation, and disruptions in autonomy and identity development. The intervention integrates yoga with Jean Watson's Human Caring Theory to support mind-body awareness, emotional regulation, hope, self-awareness, and a healing environment. The program was developed by the researchers with expert input and relevant literature.

Yoga sessions will be delivered remotely and individually through Zoom by the first researcher, who has nine years of pediatric oncology nursing experience and is trained as a children's yoga instructor. Session dates and times will be scheduled according to each participant's availability. Before each session, the participant's physical capacity and any limitations will be assessed. Yoga postures will be adapted to the participant's abilities, with emphasis on safe mind-body awareness rather than perfect performance. Written and verbal assent/consent will be obtained from adolescents and their parents before participation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 12-18 years
  • Diagnosed with an oncological disease
  • Receiving follow-up care at the Pediatric Oncology Outpatient Clinic
  • Able to understand the study scales and instructions
  • Able to attend the online sessions regularly and having the necessary internet access
  • Adolescent assent and parent/legal guardian consent obtained

Exclusion criteria

  • Requesting withdrawal from the study
  • Missing two or more yoga sessions

Treatment and study plan

Human Caring Theory-Based Individualized Online Yoga Program

Behavioral

The theory-based program incorporates yoga postures, breathing practices, relaxation, mindfulness, and mind-body awareness. Before each session, the adolescent's physical capacity and limitations will be assessed, and the postures will be adapted accordingly. Sessions will be delivered individually by a pediatric oncology researcher who is also a trained children's yoga instructor.

Primary outcomes

  1. Change in State Anxiety Level

    Time frame: 0. -4. week

    State anxiety will be assessed using the State Anxiety Inventory (STAI-I). The instrument consists of 20 items and produces a total score ranging from 20 to 80; higher scores indicate higher levels of state anxiety.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

The Effect of a Yoga Program Based on Human Carıng Theory on Anxiety Levels of Adolescents With an Oncological Diagnosis

Acronym: HCT-YA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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