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

NCT ID: NCT06171893

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2022-12-31

Brief 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.

Detailed Description

Rationale: The majority of women with angina and non-obstructive coronary arteries (INOCA) do have underlying epicardial or microvascular coronary vasospasms as revealed by invasive vasomotor testing. It is well known that stress is one of the important triggers of coronary vasospasms, therefore, stress reduction is of importance to this population. 'Wavy' is a smartphone application that estimates stress levels through a collection of physiological data by smartwatches and offers music guided relaxation through bio-feedback when these levels appear too high. It is hypothesized that the use of 'Wavy' will result in less stress and consequently fewer complaints of angina pectoris.

Objective: This study sets out to assess whether incorporating Wavy in daily life results in a better quality of life as measured through the primary outcome: visual analogue scale on pain (VAS) score and secondary outcomes: perceived stress score (PSS-10) quality of life (SF-36), heart rate variability (HRV) based stress levels, and angina frequency.

Study design: Patients will be enrolled in a single-arm placebo-controlled multicentre trial, consisting of 4 weeks placebo followed by 4 weeks intervention.

Study population: The study population will consist out of 250 women from 5 cardiology centres, aged between 18 and 70, who are diagnosed with INOCA with coronary vasomotor disorders.

Intervention: The smartphone application ''Wavy'' offers music guided relaxation when stress levels, as measured by biological parameters through the wearable, are too high.

Main study parameters/endpoints: The primary study parameter is the difference between the VAS scores before and after the intervention period.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: To ensure a low burden for the participants, the trial will be executed digitally, meaning that, aside from delivering the wearables, all contact will be through online and phone contact. Over the course of approximately two months, the participant will be asked to watch an introduction video series, explaining the proper usage of Wavy Assistant, also they will be asked to wear a smartwatch, and to use a music guided relaxation for approximately 10 minutes at a time. In addition, the participants will be asked to fill out three questionnaires twice, taking approximately ninety minutes in total. Overall, the risk of the intervention is negligible. The potential benefit of the intervention is a reduction of symptoms of angina in patients through music guided relaxation, which is a natural, non-medical therapy without risk of side effects.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control vs intervention

Each subject will take part in a four-week control period, followed by a four-week intervention period.

Group Type: EXPERIMENTAL

Wavy stress application

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Female.

2. Aged 18-70 (upper-limit, because of increased comorbidities and potential difficulties with using the technology).

3. Suffering from chronic angina pectoris.

4. Diagnosed with INOCA, documented within 2 years, with a coronary angiogram and an abnormal coronary function test (CFT), indicative of either epicardial or microvascular vasospasms.

5. Daily usage of a smartphone with an operating system equal to or higher than Android 5.0 (Lollipop) or IOS 10.0.

6. Signed written informed consent.

Excluded criteria:

1. She is not available for the assigned research period of approximately 10 weeks from May 2021 till October 2022. The application can be used during the planned holidays.

2. She is unable to participate in the stress-reducing exercise, e.g., due to hearing problems.

3. A language barrier is present.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

VieCuri Medical Centre

OTHER

Sponsor Role: collaborator

The Elisabeth-TweeSteden Hospital

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

Maasstad Hospital

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Health Holland

OTHER

Sponsor Role: collaborator

Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzette Elias-Smale, dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud universty medical center

Nijmegen, Gelderland, Netherlands

Maastricht UMC

Maastricht, Limburg, Netherlands

VieCuri

Venlo, Limburg, Netherlands

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Elisabeth-TweeSteden Hospital

Tilburg, North Brabant, Netherlands

Maasstad Hospital

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

.NL77493.091.21

Identifier Type: -

Identifier Source: org_study_id