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

NCT07670806 | Not Yet Recruiting

• 1 other identifier: OST1-019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stress; Anxiety

Keywords

Anxiety; Autonomic System Nervous; Parasympathetic Autonomic System Nervous; heart rate variability; Manual Therapy Techniques; Young Adults

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 week before intervention and 1 week after intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

Osteopathic Intervention Protocol

Other: Fourth Ventricle Technique; Other: Suboccipital Decompression; Other: Diaphragm Myofascial Release Technique; Other: Sacral Rock

Control Group

PLACEBO COMPARATOR

Sham intervention

Other: Sham Cranial Listening

Interventions

Fourth Ventricle Technique OTHER

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.

Experimental Group

Suboccipital Decompression OTHER

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.

Experimental Group

Diaphragm Myofascial Release Technique OTHER

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.

Experimental Group

Sacral Rock OTHER

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.

Experimental Group

Sham Cranial Listening OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior de Saúde do Porto

Porto, Porto District, 4200-072, Portugal

Location

Related Publications (21)

• 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.

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• 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.

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  BACKGROUND

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  BACKGROUND

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• 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.

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• 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.

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• 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

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• 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

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• 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.

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• 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.

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Natália MO Campelo

  ESS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

+351 222 061 000; nmc@ess.ipp.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Teacher

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)