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

Not Applicable

Completed

• Conditions: Vasomotor; Spasm; Angina, Stable; Vasospasm, Coronary; Prinzmetal Angina; Stress; Ischemia
• Interventions: Behavioral: Wavy stress application

• Registration Number: NCT06171893
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-31
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control vs intervention	Wavy stress application	Each subject will take part in a four-week control period, followed by a four-week intervention period.

Primary Outcome Measures

Name	Time	Method
seattle angina questionnaire	10 weeks	A valid, reproducible, responsive instrument for assessing disease-specific health status among patients with coronary artery disease

Secondary Outcome Measures

Name	Time	Method
VAS score on pain	10 weeks	Visual scale of 1-100 on pain
Heart rate variability	10 weeks	Semi semi-continuous 30 second heart rate variabillity (hrv) derived from photoplethysmogram (PPG) signal measurements each 15 minutes
Perceived stress score	10 weeks	PSS-10 questionnaire, validated questionnaire indicating perceived stress
SF-36	10 weeks	Quality of life questionnaire
Symptom diary	10 weeks	Descriptions and time labeling of experienced symptoms

Trial Locations

Locations (6)

Maastricht UMC; 🇳🇱 Maastricht, Limburg, Netherlands

Radboud universty medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Noord Brabant, Netherlands

Elisabeth-TweeSteden Hospital; 🇳🇱 Tilburg, Noord Brabant, Netherlands

Maasstad Hospital; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

VieCuri; 🇳🇱 Venlo, Limburg, Netherlands