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NCT07670806
Effects of an Osteopathic Manual Therapy Protocol on Heart Rate Variability, Stress, and Anxiety in Young Adults
Conditions: Stress, Anxiety
Sex: All
Ages: 18 Years – 30 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Escola Superior de Tecnologia da Saúde do Porto
Location: Escola Superior de Saúde do Porto Porto
Summary
Anxiety is characterized by excessive worry and anticipation of future threats, often accompanied by physiological and behavioral manifestations (American Psychiatric Association, 2013). 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 (American Psychiatric Association, 2013; Liang et al., 2020). 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.
Eligibility Criteria
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 (Sillevis \& Hansen, 2024);
* individuals with cardiovascular problems (Cavanagh et al., 2024);
* pregnant women (Loerup et al., 2019);
* those taking medications that affect cardiac function, anxiolytics, and antidepressants (Fornari 2017);
* caffeine consumption in the last 4 hours (Giles et al., 2013);
* alcohol consumption in the previous 24 hours (Damoun et al., 2024);
* tobacco use in the last 48 hours (Giles et al., 2013);
* recent cervical trauma (Krassioukov, 2009);
* students of osteopathy.
Source: ClinicalTrials.gov (NCT07670806). StuddyBuddy aggregates publicly available trial information.