AnxietyHCT-YANCT07797595
Human Caring Theory-Based Yoga and Anxiety
A study testing Human Caring Theory-Based Individualized Online Yoga Program in people with Anxiety, run by Akdeniz University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Human Caring Theory-Based Individualized Online Yoga Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 20 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Requesting withdrawal from the study
- Missing two or more yoga sessions
About this study
Official title: The Effect of a Yoga Program Based on Human Carıng Theory on Anxiety Levels of Adolescents With an Oncological Diagnosis
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Human Caring Theory-Based Individualized Online Yoga Program
- Keywords
- yoga, adolescent, cancer, theory
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Caring Theory-Based Individualized Online Yoga ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Human Caring Theory Based Individualized Online Yoga Program | Experimental | 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. Receives: Behavioral: Human Caring Theory-Based Individualized Online Yoga Program |
| CONTROL | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Level
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.
Measured: 0. -4. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu ALTUNTAŞ, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797595
- Sponsor's protocol ID
- TBAEK-975
- Acronym
- HCT-YA
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Yoga Program Based on Human Carıng Theory on Anxiety Levels of Adolescents With an Oncological Diagnosis
- ClinicalTrials.gov ID
- NCT07797595
- Acronym / sponsor ID
- HCT-YA / TBAEK-975
- Conditions
- Anxiety
- Keywords
- yoga, adolescent, cancer, theory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Caring Theory Based Individualized Online Yoga Program | Experimental | Behavioral: Human Caring Theory-Based Individualized Online Yoga ProgramParticipants 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. |
| CONTROL | No intervention | –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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Requesting withdrawal from the study
- Missing two or more yoga sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Caring Theory-Based Individualized Online Yoga ProgramThe 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. | Behavioural | Human Caring Theory Based Individualized Online Yoga Program |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Anxiety
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Human Caring Theory-Based Individualized Online Yoga Program in people with Anxiety, run by Akdeniz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Level (time frame: 0. -4. week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.