Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA

Summary

For women that experience angina symptoms with underlying vascular spasm as the cause, stress has an aggravating role. Coping with stress is therefore included as an important pillar in dealing with this chronic disease, see the European Association of Percutaneous Cardiovascular Interventions (EACPI) consensus document on INOCA. In practice, stress management focuses on informing and identifying the role stress plays in their lives. A potential stress management tool: "Wavy" aims to help users manage stress more consciously through biofeedback. This research focuses on the effectiveness of stress management applications. The hypothesis is that the app will help to avoid the trigger stress as much as possible and thus reduce the burden of disease.

Conditions

• Stress
• Ischemia
• Vasospasm, Coronary
• Vasomotor; Spasm
• Angina, Stable
• Prinzmetal Angina

Interventions

BEHAVIORAL

Wavy stress application

The intervention consists of the application named Wavy. Wavy uses artificial intelligence and the user's feedback to detect stress increasingly more efficient over time. This provides not only real-time feedback on an individual's stress level but also helps the patient to calm down using music guided relaxation. It does so with a music filter, allowing the participant to listen to music where the stress level determines the quality of the music. Thus, relaxing is rewarded by improving the experience. In this process, implicit learning is used to establish a habit of getting better at recognising increased stress levels and getting familiar with reducing stress levels more and more effectively.

Sponsors & Collaborators

• VieCuri Medical Centre

  collaborator OTHER

• The Elisabeth-TweeSteden Hospital

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Maasstad Hospital

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Health Holland

  collaborator OTHER

• Netherlands Organisation for Scientific Research

  collaborator OTHER_GOV

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Suzette Elias-Smale, dr. · Radboud University Medical Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2022-12-23

Completion

2022-12-31

Countries

• Netherlands

Study Locations