Skip to main content
OpenTrials
Completed

NCT Number: NCT06121596

Relaxation Effects of Personalized Breathing Exercises for Healthy College Students

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breathing Exercises Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technical University of Munich

Munich, Bavaria, 80992, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BREATHING EXERCISE

Behavioral

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

Primary outcomes

  1. 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

  1. Current Perceived Stress Level

    Time frame: Immediately after each 5-minute breathing exercise

    Measured on a visual analog scale ranging from 0 to 100, where zero is absolutely no stress and 100 is extreme stress.

  2. Heart Rate Variability

    Time frame: During each 5-minute breathing exercise

    Measured via blood volume pulse with a finger clip on the middle finger

  3. Peripheral Temperature

    Time frame: During each 5-minute breathing exercise

    Measured via temperature sensor on the small finger

  4. Skin Conductance

    Time frame: During each 5-minute breathing exercise

    Measured via skin conductance sensor on the index and ring finger

  5. Power in Frequency Bands

    Time frame: During each 5-minute breathing exercise

    Measured 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 outcomes

  1. Breathing Frequency

    Time frame: During the first questionnaire and video-based instructions before the baseline measurement, the 5-minute baseline measurement and during each 5-minute breathing exercise

    Measured via chest strap sensor. This is not an outcome, it measures the participant's spontaneous breathing frequency and the compliance to the breathing protocols.

  2. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: Immidiately after the last breathing exercise

    Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.

  3. Difficulty with any of the Breathing Exercises

    Time frame: Immidiately after the last breathing exercise

    Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.

  4. Transferability of Breathing Exercises into Daily Life

    Time frame: Immidiately after the last breathing exercise

    Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.

  5. One Word Description for Breathing Exercises

    Time frame: Immidiately after the last breathing exercise

    Assessed 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.

  6. Previous Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)

    Time frame: Immidiately after the last breathing exercise

    Assessed 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.

  7. Duration of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)

    Time frame: Immidiately after the last breathing exercise

    Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.

  8. Average Volume of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)

    Time frame: Immidiately after the last breathing exercise

    Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.

  9. Stress, Anxiety and Depression Score of the Past Two Weeks

    Time frame: Immidiately after the last breathing exercise

    Measured 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.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.