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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Natália MO Campelo, PhD
- Puhelinnumero: +351 222 061 000
- Sähköposti: nmc@ess.ipp.pt
Opiskelupaikat
-
-
Porto District
-
Porto, Porto District, Portugali, 4200-072
- Escola Superior de Saúde do Porto
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Experimental Group
Osteopathic Intervention Protocol
|
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.
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.
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.
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
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Anxiety Score
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Natália MO Campelo, ESS
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Ruffini N, D'Alessandro G, Mariani N, Pollastrelli A, Cardinali L, Cerritelli F. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial. Front Neurosci. 2015 Aug 4;9:272. doi: 10.3389/fnins.2015.00272. eCollection 2015.
- Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
- Chalmers JA, Quintana DS, Abbott MJ, Kemp AH. Anxiety Disorders are Associated with Reduced Heart Rate Variability: A Meta-Analysis. Front Psychiatry. 2014 Jul 11;5:80. doi: 10.3389/fpsyt.2014.00080. eCollection 2014.
- Cho 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.
- Krassioukov 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.
- Beiter R, Nash R, McCrady M, Rhoades D, Linscomb M, Clarahan M, Sammut S. The prevalence and correlates of depression, anxiety, and stress in a sample of college students. J Affect Disord. 2015 Mar 1;173:90-6. doi: 10.1016/j.jad.2014.10.054. Epub 2014 Nov 8.
- 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.
- Giles PD, Hensel KL, Pacchia CF, Smith ML. Suboccipital decompression enhances heart rate variability indices of cardiac control in healthy subjects. J Altern Complement Med. 2013 Feb;19(2):92-6. doi: 10.1089/acm.2011.0031. Epub 2012 Sep 20.
- 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.
- Fornari 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.
- Sillevis 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.
- Cavanagh 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.
- Loerup 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.
- Liem, 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.
- Yu 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.
- Abraham 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.
- American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). American Psychiatric Publishing. https://doi.org/10.1176/appi.books.9780890425596
- Liang, J., Zhang, X., Wang, J., Feng, L., Xu, C., Cheng, K., Cao, G., Yan, D., & Liu, B. (2020). Mental Health Status of College Freshmen and Influencing Factors. Psychology, 11(05), 737-747. https://doi.org/10.4236/psych.2020.115050
- Laura, C., Costa, C., Santiago, G., Graziela, R., & Maria José, C. (2024). Prevalence and risk factors for anxiety, stress and depression among higher education students in Portugal and Brazil. Journal of Affective Disorders Reports, 17, 100825. https://doi.org/10.1016/j.jadr.2024.100825
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- OST1-019
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .