A Heart Rate Variability (HRV) Biofeedback Training to Reduce Symptomatology Associated With Functional Gastrointestinal Disorders (FGID) in College Students.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
Functional Gastrointestinal Disorders (FGIDs) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. These disorders are believed to result from alterations in gut-brain communication. The most common subtypes are Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often accompanied by chronic pain, anxiety, and depression. The role of stress in the manifestation of FGIDs is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. Recent interest has focused on the use of Heart Rate Biofeedback (HRV). High levels of stress are associated with reduced HRV, which is common in patients with FGID. HRV biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. The present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with FGIDs in college students.
The project involves online screening to recruit participants, who will then be randomized to receive either the true HRV biofeedback treatment or a placebo condition. Pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. The treatment is expected to improve HRV, thereby reducing anxiety and gastrointestinal symptoms.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of clinically significant anxiety symptoms (DASS-21 > 4)
- •presence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS > 75);
- •obtaining informed consent to participate in the study;
- •Absence of organic gastrointestinal diseases: thus, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis);
- •absence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
排除标准
- •absence of clinically significant anxiety symptoms (DASS-21< 4);
- •absence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS < 75);
- •lack of obtaining Informed Consent to participate in the study;
- •presence of organic gastrointestinal diseases: therefore, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis).
- •presence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
研究组 & 干预措施
Biofeedback
The actual administration of the HRV-Biofeedback protocol: 5 HRV biofeedback training sessions of 45 minutes each, conducted biweekly.
干预措施: HRV Biofeedback Training (Behavioral)
Placebo
Placebo condition: 5 control sessions of 45 minutes each, conducted biweekly.
干预措施: Placebo Training (Other)
结局指标
主要结局
Anxiety
时间窗: Day 0 (T0); Week 4 (T1); Month 3 (T2)
The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Stress
时间窗: Day 0 (T0); Week 4 (T1); Month 3 (T2)
The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Emotion Regulation
时间窗: Day 0 (T0); Week 4 (T1); Month 3 (T2)
The Emotion Regulation Questionnaire (ERQ) is composed of ten items divided into two factors: cognitive reappraisal with six items and expressive suppression with four items. It is answered on a Likert scale ranging from 1 (total disagreement) to 7 (total agreement).
Irritable Bowel Severity
时间窗: Day 0 (T0); Week 4 (T1); Month 3 (T2)
This scale evaluates primarily the intensity of IBS symptoms during a 10-day period: abdominal pain, distension, stool frequency and consist- ency, and interference with life in general. The IBS-SSS calculates the sum of these 5 items each scored on a visual analog scale from 0 to 100. Although the IBS-SSS uses patient-rated intensity of IBS symptoms, the determination of severity by the scoring system was originally anchored to a physician's assessment of patient severity.
Heart Rate Variability
时间窗: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Electrocardiogram (ECG) and Heart Rate Variability in particular, recorded through three Ag/AgCl electrodes placed with a proximal type fitting, using the second Einthoven lead. Heart rate and HRV parameters in time and frequency and nonlinear indices will be extracted from the ECG. They will also be monitored during the proposed training (experimental and control).
次要结局
- Interception(Day 0 (T0); Week 4 (T1); Month 3 (T2))
- Emotional State(Day 0 (T0); Week 4 (T1); Month 3 (T2))
- Respiratory Rate(Day 0 (T0); Week 4 (T1); Month 3 (T2))
- Depression(Day 0 (T0); Week 4 (T1); Month 3 (T2))
研究者
Eleonora Volpato
Principal Investigator
Fondazione Don Carlo Gnocchi Onlus