Effects of an Osteopathic Manual Therapy Protocol on Heart Rate Variability, Stress, and Anxiety in Young Adults

Effect of an Osteopathic Intervention Protocol on the Parasympathetic System on Stress and Anxiety in Young Adults: a Randomized Clinical Trial

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.

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.

Inclusion Criteria:

• age between 18 and 35 years old;
• presence of symptoms/diagnosis of stress and/or anxiety in the last week.

Exclusion Criteria:

• 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.