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

July 3, 2026 updated by: Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natália MO Campelo, PhD
  • Phone Number: +351 222 061 000
  • Email: nmc@ess.ipp.pt

Study Locations

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4200-072
        • Escola Superior de Saúde do Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Osteopathic Intervention Protocol
Other: Fourth Ventricle Technique
This technique is performed with the patient in the supine position and lower limbs straight. The technique, according to Sutherland consists of a slight compression performed with the thenar eminence of the Osteopath in the supraoccipital region, precisely on the scale of the patient's occipital bone with compression initiated by the expiration phase of the primary respiratory mechanism and maintaining the compression for 5 min.
Other: Suboccipital Decompression
The patient is in the supine position, in maximum comfort. The Osteopath is located at the bedside of the table seated. Place both hands inferior to the occiput, and apply pressure to the area located between the occiput and axis, with the distal phalanges of your fingers. Then, apply a force in the anterior and cranial direction. The application of force should be maintained for 5 minutes.
Other: Diaphragm Myofascial Release Technique
The patient must position himself in the supine position with the lower limbs relaxed, the Osteopath must be at the head of the table and make a manual contact on the lower edge of the last costal arch, in the phase of inspiration the hands of the Osteopath bring laterally and cephalically the diaphragm, following the elevation of the ribs. During expiration, the Osteopath increases contact with the internal costal margin, maintaining resistance. The technique should be performed in a set of 10 deep breaths on each side, with a one-minute interval between them.
Other: Sacral Rock
The patient is in the prone position. The therapist is positioned laterally at the level of the patient's hip and places the palm of the cephalic hand over the spinous of the first spiny of the sacrum and allows his fingers to rest on the rest of the sacrum. The therapist's caudal hand is placed on the other hand with the thenar and hypothenar zone on the fourth and fifth spinous of the sacrum and the fingers of that same hand towards the patient's head. The therapist instructs the patient to inhale deeply, and the therapist follows the natural movement of the sacral base afterwards. At the end of inspiration, the therapist applies light pressure with the caudal hand to exaggerate sacral extension. The therapist then instructs the patient to exhale and follows the sacrum in flexion. At the end of exhalation, the therapist applies and maintains light pressure with the cephalic hand to exaggerate sacral flexion. This process is repeated for 3 minutes.
Placebo Comparator: Control Group
Sham intervention
Other: Sham Cranial Listening
The patient is in the supine position and the Osteopath is seated at the head of the table, contacting the patient's skull with both hands as follows: 2nd finger on the greater wings of the sphenoid, 3rd finger on the temporal bone in front of the ears, 4th finger on the temporal bone behind the ears and 5th finger on the occipital bone, while the 1st finger rests on the head, and if possible in contact with each other to act as an external fixed point. To carry out this, the Osteopath only used the contacts, as described, in a period of 5 minutes, without any therapeutic intent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Score
Time Frame: 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.
1 week before intervention and 1 week after intervention
Change in Stress Score
Time Frame: 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.
1 week before intervention and 1 week after intervention
Heart Rate Variability (change in RMSSD and pNN50)
Time Frame: 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.
Immediately before intervention and immediately after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Tecnologia da Saúde do Porto

Investigators

  • Principal Investigator: Natália MO Campelo, ESS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OST1-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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