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Relaxation Effects of Personalized Breathing Exercises for Healthy College Students

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06121596
Enrollment
42
Registered
2023-11-08
Start date
2023-07-31
Completion date
2023-11-27
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing Exercises

Keywords

Relaxation therapy, Stress-management, Breathing exercise, Stress, Anxiety, Depression

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.

Interventions

BEHAVIORALBreathing Exercise

A breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response).

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Relaxation Sum ScoreImmediately after each 5-minute breathing exerciseMeasured with the German Version of the Relaxation State Questionnaire; Sum scores range from 10 to 50 (higher scores indicate greater relaxation).

Secondary

MeasureTime frameDescription
Current Perceived Stress LevelImmediately after each 5-minute breathing exerciseMeasured on a visual analog scale ranging from 0 to 100, where zero is absolutely no stress and 100 is extreme stress.
Heart Rate VariabilityDuring each 5-minute breathing exerciseMeasured via blood volume pulse with a finger clip on the middle finger
Peripheral TemperatureDuring each 5-minute breathing exerciseMeasured via temperature sensor on the small finger
Skin ConductanceDuring each 5-minute breathing exerciseMeasured via skin conductance sensor on the index and ring finger
Power in Frequency BandsDuring each 5-minute breathing exerciseMeasured via four channel EEG with linked earlobe reference and active electrode placement on F3, F4, F7, and F8 according to the international 10-20 system

Other

MeasureTime frameDescription
Duration of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)Immidiately after the last breathing exerciseAssessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.
Breathing FrequencyDuring the first questionnaire and video-based instructions before the baseline measurement, the 5-minute baseline measurement and during each 5-minute breathing exerciseMeasured via chest strap sensor. This is not an outcome, it measures the participant's spontaneous breathing frequency and the compliance to the breathing protocols.
Stress, Anxiety and Depression Score of the Past Two WeeksImmidiately after the last breathing exerciseMeasured with the Depression-Anxiety-Stress-Scale Questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.
Average Volume of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)Immidiately after the last breathing exerciseAssessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0Immidiately after the last breathing exerciseAssessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.
Difficulty with any of the Breathing ExercisesImmidiately after the last breathing exerciseAssessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.
Transferability of Breathing Exercises into Daily LifeImmidiately after the last breathing exerciseAssessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.
One Word Description for Breathing ExercisesImmidiately after the last breathing exerciseAssessed with an open question. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.
Previous Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)Immidiately after the last breathing exerciseAssessed with a closed (Yes/No) question. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026