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临床试验/NCT06457932
NCT06457932撤回不适用

Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress and Anxiety Levels in University Undergraduate Students

University of Seville0 个研究点目标入组 54 人开始时间: 2026年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
54
主要终点
Anxiety State

研究概览

简要总结

The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and a control group, in reducing stress and anxiety levels among university undergraduate students.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Second- and third-year students of the Physiotherapy Degree at various universities in the province of Seville.
  • Enrolled in all courses for the academic year.
  • Enrolled in the courses for the first or second time.

排除标准

  • Having a job in addition to academic responsibilities.
  • Having a dependent family member under their care.
  • Diagnosed with any mental health issues.
  • Diagnosed with severe metabolic, cardiovascular, or respiratory conditions, or cancer.
  • Simultaneously pursuing another degree or a dual degree program.

研究组 & 干预措施

Biofeedback training

Experimental

An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.

干预措施: Heart rate variability biofeedback training (Behavioral)

Meditation

Active Comparator

An 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation.

干预措施: Guided meditation (Behavioral)

Control

No Intervention

Passive, waitlist control group.

结局指标

主要结局

Anxiety State

时间窗: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up

Measured using the State-Trait Anxiety Inventory (STAI).

Stress

时间窗: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up

Measured using the Percieved Stress Scale (PSS).

次要结局

  • Heart Rate Variability (HRV)(T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up)
  • Academic Performance(T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up)
  • Adherence(Daily during the 8 week intervention)

研究者

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

Hermann Fricke Comellas

PhD Student

University of Seville

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