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Clinical Trials/NCT06121596
NCT06121596
Completed
Not Applicable

Relaxation Effects of Personalized Breathing Exercises for Healthy College Students: a Randomized Crossover Trial

Technical University of Munich1 site in 1 country42 target enrollmentJuly 31, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breathing Exercises
Sponsor
Technical University of Munich
Enrollment
42
Locations
1
Primary Endpoint
Relaxation Sum Score
Status
Completed
Last Updated
last year

Overview

Brief Summary

Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation.

This study has two aims. First, it aims to personalize and optimize breathing protocols. Second, it aims to tailor breathing protocols to subgroups based on prediction models of expected efficacy.

Three different breathing protocols, varying solely in their instructed breathing frequency with 40 percent (A), 60 percent (B), and 80 percent (C) of the interindividual spontaneous breathing frequency, are tested in a randomized, counterbalanced crossover trial. Other parameters, such as breathing quality (i.e., nasal and diaphragmatic), rhythm (i.e., prolonged exhalation without instructed pauses) and depth (i.e., increased depth due to slower breathing frequency) as well as contextual factors (e.g., posture, video-based instructions, type of pacer, etc.) are invariant between protocols.

First, this study hypothesizes a difference in the relaxation response between breathing protocols A, B, and C. This study looks at the relaxation response from three different angles (1) self-report, (2) autonomic arousal, and (3) central nervous system arousal. Second, this study explores prediction models of expected efficacy based on the interindividual variance in characteristics (i.e., depressive, anxious and stress symptoms as well as expertise in relaxation therapies) and biomarkers (e.g., heart rate variability, peripheral temperature, skin conductance, etc.). Prediction models can tailor breathing protocols to subgroups to increase expected efficacy.

Registry
clinicaltrials.gov
Start Date
July 31, 2023
End Date
November 27, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Principal Investigator
Principal Investigator

Lukas Moebus

Principal Investigator

Technical University of Munich

Eligibility Criteria

Inclusion Criteria

  • Above 18 years old
  • University student
  • Native German speaker

Exclusion Criteria

  • Any psychiatric (e.g., anxiety), neurologic (e.g., epilepsy) or cardio-pulmonary (e.g., asthma) diagnosis

Outcomes

Primary Outcomes

Relaxation Sum Score

Time Frame: Immediately after each 5-minute breathing exercise

Measured with the German Version of the Relaxation State Questionnaire; Sum scores range from 10 to 50 (higher scores indicate greater relaxation).

Secondary Outcomes

  • Current Perceived Stress Level(Immediately after each 5-minute breathing exercise)
  • Heart Rate Variability(During each 5-minute breathing exercise)
  • Peripheral Temperature(During each 5-minute breathing exercise)
  • Skin Conductance(During each 5-minute breathing exercise)
  • Power in Frequency Bands(During each 5-minute breathing exercise)

Study Sites (1)

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