Clinical Research Directory

Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults

This study is a non-clinical substudy conducted within the DESTRESS research program (NCT05036538), which investigates the effects of relaxation interventions on physiological and psychological parameters. While the main DESTRESS trial focuses on cardiac surgical patients, this additional study arm examines the same interventions in a non-clinical adult population under controlled conditions, independent of disease-, surgery-, or medication-related influences. Participants are randomly assigned to one of several experimental conditions and take part in a single approximately 30-minute session. Depending on group allocation, the session may include exposure to natural soundscapes, natural soundscapes combined with binaural beats, virtual reality-based natural environments, virtual reality combined with binaural beats, or a control condition without a relaxation intervention. The primary aim of the DESTUD-Study is to assess the feasibility and potential stress-reducing effects of these non-pharmacological relaxation approaches in a non-clinical setting and to support the interpretation of findings from the clinical DESTRESS trial. Physiological responses, including heart rate variability and electrodermal activity, as well as self-reported stress measures, are collected before, during and after the conditions.

Feasibility of Breathwork Intervention With Older Adults After Knee Surgery

Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population. The body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.

Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation

The VRELAX study is a non-clinical sub-study within the "Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients"- research program (DESTRESS; NCT05036538), which investigates non-pharmacological relaxation interventions using virtual reality and binaural auditory stimulation. In a randomized counterbalanced within-subject design, non-clinical adult participants complete two sessions separated by a 1 day intervention-free interval. A 30-minute immersive nature-based virtual reality exposure combined with gradually decreasing binaural beats (10-1 Hertz (Hz)), and a control condition without relaxation. Heart rate variability (HRV) is recorded continuously, and subjective stress is assessed before and after each condition. The primary outcome is parasympathetic activation operationalized as high-frequency (HF) power of heart rate variability. Secondary outcomes include additional HRV parameters and self-reported stress ratings. The study aims to characterize short-term relaxation effects and evaluate the feasibility of independent use in everyday settings, supporting interpretation of clinical findings of the DESTRESS trial.

Sleep and Morning Wellbeing Study

The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.

Benson Relaxation Exercises and Sleep Quality in Lung Cancer Patients

The aim of this study is to investigate the effect of Benson Relaxation Exercises on sleep quality in hospitalized patients diagnosed with lung cancer. It is planned to be conducted as a randomized controlled trial. Hypotheses of the Study H1: The sleep quality of lung cancer patients who undergo Benson relaxation exercises is statistically significantly better than that of patients who do not undergo such exercises. H2: There is no significant difference in sleep quality between patients who undergo Benson relaxation exercises and those who do not.

Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia

Preeclampsia, affecting 2-8% of pregnancies globally, is a leading hypertensive disorder in pregnancy. It is clinically characterized by elevated blood pressure (≥140/90 mmHg) after the 20th gestational week, often accompanied by proteinuria and systemic complications such as thrombocytopenia, liver dysfunction, and cerebral symptoms. This condition poses significant risks for both maternal and fetal health, increasing the likelihood of organ damage, preterm birth, and long-term cardiovascular and neurodevelopmental complications. Non-pharmacological interventions, including relaxation techniques, have been explored for symptom management. Progressive muscle relaxation (PMR) has shown efficacy in reducing stress, anxiety, and blood pressure. Recently, virtual reality (VR)-based relaxation techniques have gained attention for enhancing stress relief and improving health outcomes. This study aims to compare the effects of VR-based PMR with in-person PMR on maternal and fetal outcomes in preeclamptic pregnancies.

Training of Relaxation Breathing in Virtual Reality Using Biofeedback: Comparison Study

This study aims to evaluate the effectiveness of a VR-based relaxation breathing training with biofeedback compared to a non-biofeedback version in patients with anxiety disorders. The randomized controlled trial will include at least 30 participants (15 per group) diagnosed with an anxiety disorder (DSM-5 or ICD-10 criteria). The intervention will use BreezeTerraVR, a custom-built virtual reality (VR) application developed by VR research center team members at NIMH. This app provides training in deep relaxation breathing technique with or without biofeedback (BF - visual elements reflecting real-time breathing patterns measured via breathing belt) in a virtual nature environment. This study compares two subgroups of anxiety patients, both completing four 20-minute intervention sessions, two sessions with BF and two without BF (in randomized order). This study will assess the feasibility of the VR intervention, estimate effect sizes, and provide preliminary insights into its impact on relaxation training in individuals with anxiety disorders. This study is funded by the European Union's co-financed project "Research of Excellence on Digital Technologies and Wellbeing CZ.02.01.01/00/22\_008/0004583."

Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials

Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation. The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination. The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience

APA and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in ICU

Adapted Physical Activity (APA) is accepted as an effective, recommended and beneficial supportive care for the health of people with cancer during the different phases of the disease. The objective of the project is to analyse the effect of APA programs (Classic, Exergaming and Relaxation) on the state anxiety of people with severe blood diseases admitted to Intensive Care Unit (ICU). Anxiety is a major affect in this context. The interest of the practice of APA for this public is to reduce the level of state anxiety and to limit the decline of functional capacities. The main objective of this work is to identify whether specific and/or complementary effects result from the use of biofeedback and/or Exergaming.

Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment

The goal of this pilot study is to learn if aromatherapy helps to reduce stress and improve relaxation and wellbeing in gynaecological cancer patients after they have finished their treatment for cancer. The main questions this study aims to answer are: Is there a benefit in using an aromatherapy product for relaxation and wellbeing after completion of cancer treatment. Researchers will compare a commercially available aromatherapy test oil blend to a control oil (an oil at high dilution with a faint aroma) to see if the oil blend helps to reduce stress and increase wellbeing and relaxation. Participants will: Use a commercially available aromatherapy product or a control every evening for 4 weeks and complete a questionnaire at the start, after 2 weeks and at the end of the 4 week period. During the four weeks of the study, the participants may wish to record their experience with the test oil and assess its impact on relaxation and wellbeing in a personal diary.