- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07797595
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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.
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in State Anxiety Level
Tidsramme: 0. -4. week
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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.
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0. -4. week
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TBAEK-975
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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