Human Caring Theory-Based Yoga and Anxiety (HCT-YA)
The Effect of a Yoga Program Based on Human Carıng Theory on Anxiety Levels of Adolescents With an Oncological Diagnosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Human Caring Theory Based Individualized Online Yoga Program
Participants will receive an individualized online yoga program delivered through Zoom for four weeks.
Sessions will be conducted twice weekly, with each session lasting 60 minutes, for a total of eight sessions.
|
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.
|
|
No Intervention: CONTROL
Participants in the control group will receive no study-specific yoga intervention and will complete the same data collection forms at the prespecified assessment time points.
Usual oncology care will continue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0. -4. week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBAEK-975
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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