Clinical trial NCT06121596: Relaxation Effects of Personalized Breathing Exercises for Healthy College Students
Official title: Relaxation Effects of Personalized Breathing Exercises for Healthy College Students: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing Exercises
Keywords: Relaxation therapy
Stress-management
Breathing exercise
Stress
Anxiety
Depression
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Relaxation Sum Score
timeFrame: Immediately after each 5-minute breathing exercise
Secondary outcomes:
measure: Current Perceived Stress Level
timeFrame: Immediately after each 5-minute breathing exercise
measure: Heart Rate Variability
timeFrame: During each 5-minute breathing exercise
measure: Peripheral Temperature
timeFrame: During each 5-minute breathing exercise
measure: Skin Conductance
timeFrame: During each 5-minute breathing exercise
measure: Power in Frequency Bands
timeFrame: During each 5-minute breathing exercise
Other outcomes:
measure: Breathing Frequency
timeFrame: During the first questionnaire and video-based instructions before the baseline measurement, the 5-minute baseline measurement and during each 5-minute breathing exercise
measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: Immidiately after the last breathing exercise
measure: Difficulty with any of the Breathing Exercises
timeFrame: Immidiately after the last breathing exercise
measure: Transferability of Breathing Exercises into Daily Life
timeFrame: Immidiately after the last breathing exercise
measure: One Word Description for Breathing Exercises
timeFrame: Immidiately after the last breathing exercise
measure: Previous Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)
timeFrame: Immidiately after the last breathing exercise
measure: Duration of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)
timeFrame: Immidiately after the last breathing exercise
measure: Average Volume of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)
timeFrame: Immidiately after the last breathing exercise
measure: Stress, Anxiety and Depression Score of the Past Two Weeks
timeFrame: Immidiately after the last breathing exercise
Locations:
city: Munich
country: Germany
facility: Technical University of Munich
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Lukas Moebus, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: