StressNCT07670806
Effects of an Osteopathic Manual Therapy Protocol on Heart Rate Variability, Stress, and Anxiety in Young Adults
A study testing Fourth Ventricle Technique, Suboccipital Decompression and Diaphragm Myofascial Release Technique in people with Stress and Anxiety, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- What is being tested?
- Fourth Ventricle Technique, Suboccipital Decompression and Diaphragm Myofascial Release Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- Jun 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 35 years old;
- presence of symptoms/diagnosis of stress and/or anxiety in the last week.
Who cannot join
- 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;
Show all 9Show fewer
- tobacco use in the last 48 hours;
- recent cervical trauma;
- students of osteopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Escola Superior de Saúde do Porto
Porto, Porto District, 4200-072
About this study
Official title: 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?
Read more
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.
Read the 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.
- Being tested
- Fourth Ventricle Technique, Suboccipital Decompression, Diaphragm Myofascial Release Technique, Sacral Rock, Sham Cranial Listening
- Keywords
- Anxiety, Autonomic System Nervous, Parasympathetic Autonomic System Nervous, heart rate variability, Manual Therapy Techniques, Young Adults
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fourth Ventricle TechniqueOther
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.
Suboccipital DecompressionOther
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.
Diaphragm Myofascial Release TechniqueOther
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.
Sacral RockOther
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.
Sham Cranial ListeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Osteopathic Intervention Protocol Receives: Other: Fourth Ventricle Technique; Other: Suboccipital Decompression; Other: Diaphragm Myofascial Release Technique; Other: Sacral Rock |
| Control Group | Placebo comparator | Sham intervention Receives: Other: Sham Cranial Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (change in RMSSD and pNN50)
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.
Measured: Immediately before intervention and immediately after intervention.
Change in Anxiety Score
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.
Measured: 1 week before intervention and 1 week after intervention
Change in Stress Score
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.
Measured: 1 week before intervention and 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, Principal investigator, ESS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670806
- Sponsor's protocol ID
- OST1-019
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damoun N, Amekran Y, Taiek N, Hangouche AJE. Heart rate variability measurement and influencing factors: Towards the standardization of methodology. Glob Cardiol Sci Pract. 2024 Aug 1;2024(4):e202435. doi: 10.21542/gcsp.2024.35. eCollection 2024 Aug 1.
PubMed 39351472Fornari M, Carnevali L, Sgoifo A. Single Osteopathic Manipulative Therapy Session Dampens Acute Autonomic and Neuroendocrine Responses to Mental Stress in Healthy Male Participants. J Am Osteopath Assoc. 2017 Sep 1;117(9):559-567. doi: 10.7556/jaoa.2017.110.
PubMed 28846122Krassioukov A. Autonomic function following cervical spinal cord injury. Respir Physiol Neurobiol. 2009 Nov 30;169(2):157-64. doi: 10.1016/j.resp.2009.08.003. Epub 2009 Aug 12.
PubMed 19682607Sillevis R, Hansen AW. Could the Suboccipital Release Technique Result in a Generalized Relaxation and Self-Perceived Improvement? A Repeated Measure Study Design. J Clin Med. 2024 Oct 2;13(19):5898. doi: 10.3390/jcm13195898.
PubMed 39407957Cavanagh M, Cope T, Smith D, Tolley I, Orrock P, Vaughan B. The effectiveness of an osteopathic manual technique compared with a breathing exercise on vagal tone as indicated by heart rate variability, a crossover study. J Bodyw Mov Ther. 2024 Apr;38:449-453. doi: 10.1016/j.jbmt.2024.01.003. Epub 2024 Jan 7.
PubMed 38763591Loerup L, Pullon RM, Birks J, Fleming S, Mackillop LH, Gerry S, Watkinson PJ. Trends of blood pressure and heart rate in normal pregnancies: a systematic review and meta-analysis. BMC Med. 2019 Sep 11;17(1):167. doi: 10.1186/s12916-019-1399-1.
PubMed 31506067Liem, T., McPartland, J. M., & Skinner, E. (Eds.). (2012). Cranial osteopathy (2nd ed). Elsevier/Churchill Livingstone.
Marizeiro, D. F., & Campos, N. G. (sem data). IMMEDIATE EFFECTS OF MIOFASCIAL DIAPHRAGMATIC RELEASE ON LOMBAR COLUMN AND DIAPHRAGMA FUNCTION: A RANDOMIZED PLACEBO- CONTROLLED TRIAL.
Roque, J. M. A. (2009). VARIABILIDADE DA FREQUÊNCIA CARDÍACA.
Tiwari R, Kumar R, Malik S, Raj T, Kumar P. Analysis of Heart Rate Variability and Implication of Different Factors on Heart Rate Variability. Curr Cardiol Rev. 2021;17(5):e160721189770. doi: 10.2174/1573403X16999201231203854.
PubMed 33390146Yu K, Pfotenhauer K, Pierce-Talsma S. OMT for Patients With Sacral Somatic Dysfunction. J Am Osteopath Assoc. 2018 Mar 1;118(3):e15. doi: 10.7556/jaoa.2018.041. No abstract available.
PubMed 29480923Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.
PubMed 25642072Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
PubMed 22182954Abraham C, Sloan SNB, Coker C, Freed B, McAuliffe M, Nielsen H, Riscoe T, Steele R, Dettwiler A, Oberley G, Zaremski K, Joy K, Selby A, Wells-Lewis R, Creamer BA. Osteopathic Manipulative Treatment as an Intervention to Reduce Stress, Anxiety, and Depression in First Responders: A Pilot Study. Mo Med. 2021 Sep-Oct;118(5):435-441.
PubMed 34658436American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). American Psychiatric Publishing. https://doi.org/10.1176/appi.books.9780890425596
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Osteopathic Intervention Protocol on the Parasympathetic System on Stress and Anxiety in Young Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07670806
- Acronym / sponsor ID
- OST1-019
- Keywords
- Anxiety, Autonomic System Nervous, Parasympathetic Autonomic System Nervous, heart rate variability, Manual Therapy Techniques, Young Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Fourth Ventricle Technique, Other: Suboccipital Decompression, Other: Diaphragm Myofascial Release Technique, Other: Sacral RockOsteopathic Intervention Protocol |
| Control Group | Placebo comparator | Other: Sham Cranial ListeningSham intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18 and 35 years old;
- presence of symptoms/diagnosis of stress and/or anxiety in the last week.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fourth Ventricle TechniqueThis 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 | Experimental Group |
| Suboccipital DecompressionThe 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 | Experimental Group |
| Diaphragm Myofascial Release TechniqueThe 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 | Experimental Group |
| Sacral RockThe 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. | Other | Experimental Group |
| Sham Cranial ListeningThe 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. | Other | Control Group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 39351472Damoun N, Amekran Y, Taiek N, Hangouche AJE. Heart rate variability measurement and influencing factors: Towards the standardization of methodology. Glob Cardiol Sci Pract. 2024 Aug 1;2024(4):e202435. doi: 10.21542/gcsp.2024.35. eCollection 2024 Aug 1.
- Background: PubMed 28846122Fornari M, Carnevali L, Sgoifo A. Single Osteopathic Manipulative Therapy Session Dampens Acute Autonomic and Neuroendocrine Responses to Mental Stress in Healthy Male Participants. J Am Osteopath Assoc. 2017 Sep 1;117(9):559-567. doi: 10.7556/jaoa.2017.110.
- Background: PubMed 19682607Krassioukov A. Autonomic function following cervical spinal cord injury. Respir Physiol Neurobiol. 2009 Nov 30;169(2):157-64. doi: 10.1016/j.resp.2009.08.003. Epub 2009 Aug 12.
- Background: PubMed 39407957Sillevis R, Hansen AW. Could the Suboccipital Release Technique Result in a Generalized Relaxation and Self-Perceived Improvement? A Repeated Measure Study Design. J Clin Med. 2024 Oct 2;13(19):5898. doi: 10.3390/jcm13195898.
- Background: PubMed 38763591Cavanagh M, Cope T, Smith D, Tolley I, Orrock P, Vaughan B. The effectiveness of an osteopathic manual technique compared with a breathing exercise on vagal tone as indicated by heart rate variability, a crossover study. J Bodyw Mov Ther. 2024 Apr;38:449-453. doi: 10.1016/j.jbmt.2024.01.003. Epub 2024 Jan 7.
- Background: PubMed 31506067Loerup L, Pullon RM, Birks J, Fleming S, Mackillop LH, Gerry S, Watkinson PJ. Trends of blood pressure and heart rate in normal pregnancies: a systematic review and meta-analysis. BMC Med. 2019 Sep 11;17(1):167. doi: 10.1186/s12916-019-1399-1.
- BackgroundLiem, T., McPartland, J. M., & Skinner, E. (Eds.). (2012). Cranial osteopathy (2nd ed). Elsevier/Churchill Livingstone.
- BackgroundMarizeiro, D. F., & Campos, N. G. (sem data). IMMEDIATE EFFECTS OF MIOFASCIAL DIAPHRAGMATIC RELEASE ON LOMBAR COLUMN AND DIAPHRAGMA FUNCTION: A RANDOMIZED PLACEBO- CONTROLLED TRIAL.
- BackgroundRoque, J. M. A. (2009). VARIABILIDADE DA FREQUÊNCIA CARDÍACA.
- Background: PubMed 33390146Tiwari R, Kumar R, Malik S, Raj T, Kumar P. Analysis of Heart Rate Variability and Implication of Different Factors on Heart Rate Variability. Curr Cardiol Rev. 2021;17(5):e160721189770. doi: 10.2174/1573403X16999201231203854.
- Background: PubMed 29480923Yu K, Pfotenhauer K, Pierce-Talsma S. OMT for Patients With Sacral Somatic Dysfunction. J Am Osteopath Assoc. 2018 Mar 1;118(3):e15. doi: 10.7556/jaoa.2018.041. No abstract available.
- Background: PubMed 25642072Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natália MO Campelo principal investigator
ESS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fourth Ventricle Technique, Suboccipital Decompression and Diaphragm Myofascial Release Technique in people with Stress and Anxiety, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (+351 222 061 000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (change in RMSSD and pNN50) (time frame: Immediately before intervention and immediately after intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07670806, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.