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临床试验/NCT07797595
NCT07797595尚未招募不适用

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

Akdeniz University0 个研究点目标入组 112 人开始时间: 2026年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
112
主要终点
Change in State Anxiety Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Human Caring Theory-Based Individualized Online Yoga Program (Behavioral)

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.

结局指标

主要结局

Change in State Anxiety Level

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu ALTUNTAŞ

Lecturer

Akdeniz University

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Human Caring Theory-Based Yoga and Anxiety | 临床试验