Effect of an Osteopathic Intervention Protocol on the Parasympathetic System on Stress and Anxiety in Young Adults: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Anxiety Score
研究概览
简要总结
Anxiety is characterized by excessive worry and anticipation of future threats, often accompanied by physiological and behavioral manifestations. Anxiety disorders are among the most prevalent mental health conditions worldwide and represent a significant public health concern, particularly among young adults and university students, who frequently experience academic, social, and financial stressors. The aim of this randomized clinical trial is to evaluate the effect of a protocol, consisting of 4 manual techniques, compared to a placebo group, in heart rate variability immediately after the intervention and in anxiety after one week in young adults. The main questions it aims to answer are:
Does the osteopathic intervention protocol influence the parasympathetic nervous system? Does the osteopathic intervention protocol influence anxiety and stress?
The researchers will compare the osteopathic protocol to a placebo (simulation technique), in order to see if the protocol influences anxiety and stress. Participants will:
Prior to the intervention, complete the EADS questionnaire and undergo measurement of heart rate variability; Undergo the protocol or placebo; Immediately after the intervention, they will undergo the measurement of heart rate variability; After one week in the intervention, complete the questionnaire EADS.
详细描述
Stress and anxiety are highly prevalent mental health conditions, particularly among young adults and university students, and are associated with reduced well-being, impaired academic performance, and autonomic nervous system (ANS) dysregulation. Increased sympathetic activity and reduced parasympathetic activity have been linked to psychological distress, with heart rate variability (HRV) being recognized as a reliable biomarker of autonomic function. Lower HRV parameters, particularly RMSSD and pNN50, have been associated with higher levels of stress and anxiety.
Osteopathic Manipulative Treatment (OMT) may influence autonomic regulation by reducing musculoskeletal tension and promoting parasympathetic activity. The present randomized controlled trial aims to investigate the effects of a manual therapy protocol consisting of Compression of the Fourth Ventricle (CV4), suboccipital decompression, diaphragmatic myofascial release, and sacral rocking on HRV, stress, and anxiety in young adults. These techniques were selected based on their potential influence on vagal activity, respiratory mechanics, and autonomic nervous system regulation.
Participants will be randomly allocated to either an intervention group receiving the manual therapy protocol or a placebo group. The primary outcome is the immediate effect of the intervention on HRV parameters (RMSSD and pNN50), while secondary outcomes include changes in self-reported stress and anxiety symptoms one week after the intervention (EADS-21). The study aims to determine whether a single-session manual therapy protocol can improve autonomic regulation and reduce short-term symptoms of stress and anxiety.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The initial evaluation will be carried out by an independent researcher, not involved in the implementation of the interventions. At first, participants will fill out the EADS questionnaire and, subsequently, data on heart rate variability will be collected. Once the initial assessment is completed, the researcher responsible for it will leave the room, being replaced by the researcher assigned to the application of the intervention, according to the previously assigned group. After completion of the intervention, the researcher responsible for the initial assessment will return to the room and perform the final assessment, repeating the procedure of collecting heart rate variability, remaining blind to the intervention applied. Participants will also not be informed about the group to which they belong, ensuring the condition of double blindness.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 35 years old;
- •presence of symptoms/diagnosis of stress and/or anxiety in the last week.
排除标准
- •individuals with cognitive impairments that prevent participation;
- •individuals with cardiovascular problems;
- •pregnant women;
- •those taking medications that affect cardiac function, anxiolytics, and antidepressants;
- •caffeine consumption in the last 4 hours;
- •alcohol consumption in the previous 24 hours;
- •tobacco use in the last 48 hours;
- •recent cervical trauma;
- •students of osteopathy.
研究组 & 干预措施
Experimental Group
Osteopathic Intervention Protocol
干预措施: Suboccipital Decompression (Other)
Experimental Group
Osteopathic Intervention Protocol
干预措施: Diaphragm Myofascial Release Technique (Other)
Control Group
Sham intervention
干预措施: Sham Cranial Listening (Other)
Experimental Group
Osteopathic Intervention Protocol
干预措施: Fourth Ventricle Technique (Other)
Experimental Group
Osteopathic Intervention Protocol
干预措施: Sacral Rock (Other)
结局指标
主要结局
Change in Anxiety Score
时间窗: 1 week before intervention and 1 week after intervention
Anxiety symptoms assessed using the Anxiety subscale of the Portuguese version of the Depression Anxiety Stress Scale (DASS-21/EADS-21). Higher scores indicate greater anxiety symptoms.
Change in Stress Score
时间窗: 1 week before intervention and 1 week after intervention
Stress symptoms assessed using the Stress subscale of the Portuguese version of the Depression Anxiety Stress Scale (DASS-21/EADS-21). Higher scores indicate greater stress symptoms.
Heart Rate Variability (change in RMSSD and pNN50)
时间窗: Immediately before intervention and immediately after intervention.
Heart Rate Variability (HRV) is defined as the time between adjacent heartbeats (IBI). This is regulated by the interactions of the divisions of the autonomic nervous system. The analysis of heart rate variability that allows the observation of the Fluctuations that occur over periods of time is a non-invasive method and selective observation of ANS function. For the analysis of the cardiovagal function, the methods developed typically involve the measurement of heart rate variability. Root Mean Square of Successive Differences (RMSSD), a time-domain heart rate variability parameter reflecting parasympathetic nervous system activity, measured using a Polar H10 heart rate monitor and Elite HRV software. Percentage of adjacent normal-to-normal intervals differing by more than 50 ms (pNN50), a heart rate variability parameter associated with parasympathetic activity, measured using a Polar H10 heart rate monitor and Elite HRV software.
次要结局
未报告次要终点
研究者
Natália Maria Oliveira Campelo
Doctor Teacher
Escola Superior de Tecnologia da Saúde do Porto