Istanbul Health and Technology University
Istanbul, Beyoğlu, 34421, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07594873
This project aims to investigate the acute effects of controlled breathing exercises and music therapy on parasympathetic nervous system activation and increased heart rate variability in anxious individuals.
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
Istanbul, Beyoğlu, 34421, Turkey (Türkiye)
Location status: Recruiting
The main objective of our project is to reduce the suppressive effect of stress on the parasympathetic nervous system and, accordingly, to increase heart rate variability in individuals with anxiety through controlled breathing exercises and music therapy applications. For this purpose, individuals aged between 18 and 40 years who have moderate anxiety levels according to the State-Trait Anxiety Inventory, who have not previously been diagnosed with any cardiovascular, respiratory, neurological, or psychiatric diseases, and who have not smoked for at least the past 6 months will be included in the study.
The individuals included in the study will be randomly assigned into three groups: a control group, a controlled breathing exercise group, and a music-supported breathing exercise group. At the baseline assessment, the State-Trait Anxiety Inventory will be used to determine the anxiety levels of all participants and to ensure group homogenization. In addition to determining anxiety levels at baseline, heart rate variability, blood pressure, heart rate, and oxygen saturation will be assessed in all groups.
No intervention will be applied to the control group; only assessments will be conducted. A single-session exercise protocol lasting 20 minutes will be applied to the breathing exercise group and the music-supported breathing exercise group. Heart rate variability will be measured using the Polar H9 device and Elite HRV software. Blood pressure and heart rate measurements will be performed using a digital blood pressure monitor. Oxygen saturation will be determined using a fingertip pulse oximeter.
The heart rate variability, blood pressure, heart rate, and oxygen saturation assessments performed at baseline will be repeated at the 0th, 10th, and 20th minutes after the completion of the exercise in the intervention groups. In the control group, participants will be asked to remain seated for 20 minutes, and following the completion of this period, the measurements performed at baseline will be repeated at the 0th, 10th, and 20th minutes. Thus, the final evaluation will be completed, and the obtained data will be analyzed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Controlled breathing exercises include Resonance Breathing Exercises, Nadi Shodhana Pranayama, Bhramari Pranayama, and physiological sighing exercises. The controlled breathing exercise group will receive these exercises in a single 20-minute session. Resonance breathing will be practiced for 5 minutes at a rate of 6 breaths per minute. During the intervention, patients will receive 2 sets of Nadi Shodhana Pranayama consisting of 8 breathing cycles, with a 2-minute rest period between sets. The session will also include 2 sets of Bhramari Pranayama consisting of 8 breathing cycles at a low breathing rate, with a 1-minute rest period between sets. The physiological sighing exercise involves an initial inhalation phase lasting 1 second, a second inhalation phase lasting 0.25 seconds, and an exhalation phase lasting 2 seconds, and is repeated for 5 minutes.
The music-assisted breathing exercise will perform the same breathing exercises (resonant breathing, nadi shodhana, bhramari pranayama, and physiological sighing) along with music. Music-assisted breathing exercise will be performed in a single session lasting a total of 20 minutes. Music 1 (250-1000 Hz) and Music 2 (1000-16000 Hz) will be used at specific frequencies. A slow, rhythmically consistent, vocalless basic melody will be selected within these frequency ranges. The volume levels of all tracks will be kept constant. The music will be played through stereo headphones. Participants will listen to Music 1 (250-1000 Hz) for 10 minutes and Music 2 (1000-16000 Hz) for another 10 minutes. Individuals will be provided with an environment where disturbing factors (sound, light) are prevented.
Time frame: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
To assess the autonomic nervous system, heart rate variability will be evaluated. A Polar H9 heart rate sensor chest strap and Elite HRV software will be used to measure analytical heart rate variability. During the assessment, the participant will be in a seated position in a chair, the Polar system chest strap will be placed directly over the sternum, and ultrasound gel will be used to increase the conductivity of the sensor. This method has validity with electrocardiogram. Heart rate variability parameters such as RMSSD, PNN50, and LF/HF will be measured.
Time frame: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
Pulse measurements will be performed using an Omron brand digital blood pressure monitor. Individuals will be rested for at least 5 minutes before the measurement to ensure relaxation for an accurate reading.
Time frame: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
Blood pressure measurements will be performed using an Omron brand digital blood pressure monitor. Individuals will be rested for at least 5 minutes before the measurement to ensure relaxation for an accurate reading.
Time frame: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
Pulse oximetry is a non-invasive, painless, and reliable method used to measure oxygen saturation (SpO2) in arterial blood. Oxygen saturation measurement will be performed with a finger-type pulse oximeter device.
Time frame: Baseline
To determine the anxiety level of all participants and to ensure group homogeneity, the State-Trait Anxiety Scale will be used. Individuals with moderate anxiety according to the State-Trait Anxiety Scale will be included in the study. This scale aims to assess the intensity of the emotions or behaviors expressed in the items on the scale. Theoretically, scores on this scale can range from 20 to 80. A higher score indicates a high level of anxiety, while a lower score indicates a low level of anxiety.
Contact information is provided by the study sponsor or research team.
Istanbul Health and Technology University
Other
The Acute Effects of Controlled Breathing Exercises and Music Therapy on the Autonomic Nervous System in Anxious Individuals: A Randomized Controlled Study
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