CARINAE for Stress Relief in Perioperative Care

NCT05184725 | Completed DMC

• 1 other identifier: CAR-0320
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 5

Brief Summary

Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure. Provision of education and information about the surgery can be a crucial component of the preoperative experience and is inversely related to levels of preoperative anxiety. However, resource constraints make face-to-face education sessions untenable, given cost considerations and time investment by trained health personnel. Interventions based on mobile health (mHealth) technologies, geared towards increasing familiarity with surgical procedures and hospital environments have been shown to help patients feel informed about possible benefits and risks of available treatment options. mHealth apps and Virtual Reality (VR) can offer patients experience in the perioperative environment that can be helpful in empowering patients and enhancing a more positive experience, while reducing stress. However, available applications focus only on providing informative content, neglecting the importance of patient empowerment with a more robust educational curriculum. According to this, the Software as a Medical Device (SaMD) CARINAE, aims to support patients and caregivers during the whole perioperative process. SaMD CARINAE consists of an mHealth mobile application for patients and caregivers, a Virtual Reality headset for patients, and a web application for healthcare professionals.

Conditions

Psychological Stress; Cardiopulmonary Bypass Surgery; Coronary Artery Bypass Surgery; Cardiac Valve Replacement; Hip Replacement; Orthognathic Surgery; Scoliosis; Knee Replacement; Prostate Cancer; Kidney Cancer; Bladder Cancer

Keywords

Pre-operative Stress; mHealth Device; Virtual Reality (VR); Health Recommender System; I-Change Behavioral Change Model; Artificial Intelligence (AI); Software as a Medical Device (SaMD)

Outcome Measures

Primary Outcomes (8)

• Visual Analog Scale for Stress

  Patient and caregiver-reported visual analog scale question to assess subjective stress. Along a 100 mm horizontal line, patient and caregiver indicate their perceived stress intensity. Rating varies from 0 (minimum values) to 100 (maximum value). Ratings of 0 to 4 mm can be considered no stress; 5 to 44 mm, mild stress; 45 to 74 mm, moderate stress; and 75 to 100 mm, severe stress.

  2 months: from baseline to 14 days after the surgery

• Visual Analog Scale for Pain

  Patient-reported visual analog scale question to assess subjective pain. Along a 100 mm horizontal line, patient and caregiver indicate their perceived pain intensity. Rating varies from 0 (minimum values) to 100 (maximum value). Ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.

  2 months: from baseline to 14 days after the surgery

• Hospital Anxiety and Depression Scale

  Patient-reported questionnaire on anxiety and depression levels during the hospital stay. Hospital Anxiety and Depression Scale is a fourteen-item scale with seven items each for anxiety and depression subscales evaluated on a 0-3 Likert Scale. Rating varies from 0 to 21 and a subscale score \>8 denotes anxiety or depression.

  45 days: From hospital admission to 14 days after the surgery

• Health-related Quality of Life - EQ-5D-3L/-Y

  Patient-reported questionnaire on quality of life. The questionnaire consists of five items related each to one dimension: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.

  45 days: From hospital admission to 14 days after the surgery

• The Positive and Negative Affect Schedule

  Patient-reported questionnaire on emotional status. It consists of 20 items that describe n emotions of a positive or negative nature, 10 of them positive and 10 negative. Each item is answered using an Likert-tscale with 5 response options (not at all, very little, somewhat, quite a lot, very much). Scores can range from 10 - 50, with higher scores representing higher levels of positive or negative affect.

  45 days: From hospital admission to 14 days after the surgery

• The Short Warwick-Edinburgh Mental Well-Being Scale

  Patient- and caregiver-reported questionnaire on mental well-being. It consists of 7 items and each item is answered using a 1-5 Likert scale. Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing.

  2 months: from baseline to 14 days after the surgery

• General Self-Efficacy Scale

  Patient- and caregiver-reported questionnaire on self-efficacy perception. It consists of 10 items evaluated on a 1-4 Likert scale. Scores range from 10 to 40 amd higher scores indicate higher self-efficacy.

  2 months: from baseline to 14 days after the surgery

• Patient Activation Measure

  Patient-reported questionnaire on the level of activation. It consists of 13 items that have four possible response options ranging from (1) strongly disagree to (4) strongly agree, and an additional "not applicable" option. To calculate the total score, the raw score is divided by the number of items answered (excepting non-applicable items) and multiplied by 13. Then, this score is transformed to a scale with a theoretical range 0-100, based on calibration tables, with higher scores indicating higher patient activation. The raw scores can be converted into four activation levels: 1 (≤47.0) not believing activation important, 2 (47.1-55.1) a lack of knowledge and confidence to take action, 3 (55.2-67.0) beginning to take action and 4 (≥67.1) taking action.

  45 days: From baseline to hospital discharge

Secondary Outcomes (4)

• System Usability Scale

  30 days: from hospital admission to 14 days after surgery

• Usability questionnaire

  30 days: from hospital admission to 14 days after surgery

• Net Promoter Score

  30 days: from hospital admission to 14 days after surgery

• Reliability

  Day 60

Study Arms (2)

Control Group

NO INTERVENTION

Patients will follow the usual care procedures and after each procedure they answer questionnaires related to pain and stress levels (VAS), Anxiety and depression levels (HADS), health-related quality of life (HRQoL), mental wellbeing (SWEMWBS), self-efficacy (GSE) and Patient Activation status (PAM-13).

SaMD CARINAE

EXPERIMENTAL

Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately, a patientcentred digital health support program. The intervention trial will include a total of 4 visits: 1. Baseline (2-4 weeks before surgery); 2. Hospital admission (1-3 days before surgery); 3. Hospital discharge (1 week after the surgery approx.); 4. Post-operative day 14 (2 weeks after the surgery approx). After each visit and intervention trial with SaMD CARINAE the experimental group answer the same questionnaires of the control group, above mentioned Participants allocated to the intervention group will also be asked to complete questionnaires about usability, satisfaction and subjective experience.

Device: SaMD CARINAE

Interventions

SaMD CARINAE DEVICE

SaMD CARINAE delivers the following digital therapeutic intervention to the patients: 1) Personalised patient-centred health education program to improve patient's disease and recovery self-management skills. 2) AI-based behaviour change program to promote healthier lifestyle habits. 3) Personalised mental well-being coaching program to improve patient's ability to cope with emotional disturbances such as stress and anxiety. 4) A collaborative digital support platform to enable information exchange between patients, caregivers, and healthcare professionals.

SaMD CARINAE

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for one of the selected surgery types:
• Cardiopulmonary bypass (CPB) surgery (Maastricht UMC+)
• Coronary artery bypass surgery (Maastricht UMC+)
• Cardiac valve replacement (SAS, Maastricht UMC+)
• Prostate, kidney, and bladder cancer surgery (INRCA)
• Hip and knee replacement (HSJD; Parc Tauli)
• Maxillofacial surgery (HSJD)
• Orthognathic surgery (HSJD)
• Scoliosis (HSJD)
• Signed informed consent (by patient or legal guardian in paediatric cases).
• Patients ≥ 18 years old, except for paediatric Hospital San Joan de Deu (HSJD) ≥ 8 years old.
• Patient owns a smartphone with Android version 4.4 or above.
• Patient (or legal guardian/caregiver in paediatric cases) is able to demonstrate basic digital literacy (e.g. knows how to communicate through instant messaging apps or similar).

You may not qualify if:

• Dementia.
• Pregnant women.
• Inability to understand the local language.
• Allergic to dedicated wearable material (stainless steel and silicone).
• Currently enrolled in a different clinical trial.

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Maastricht University Medical Center: collaborator
• Hospital Sant Joan de Deu: collaborator
• Parc Taulí Hospital Universitari: collaborator
• Hospital Universitario Reina Sofia de Cordoba: collaborator
• Istituto Nazionale di Ricovero e Cura per Anziani: collaborator

Study Sites (5)

Istituto di Ricovero e Cura per Anziani

Ancona, Italy

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Hospital Reina Sofía

Córdoba, Andalusia, 14004, Spain

Location

Hospital San Joan de Deu

Esplugues de Llobregat, Catalonia, 08950, Spain

Location

Hospital Parc Taulí

Sabadell, Catalonia, 08208, Spain

Location

Related Publications (10)

• Crichton, N. Visual analogue scale (VAS). J Clin Nurs. 2001; 10(5): 706-6.

  BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.

  PMID: 19228398 BACKGROUND

• Schwarzer, R., & Jerusalem, M. Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs. Windsor, UK: NFER-NELSON. 1995; 35-37.

  BACKGROUND

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

  PMID: 15230939 BACKGROUND

• Brooke, J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996; 189(194): 4-7.

  BACKGROUND

• Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124.

  PMID: 14712543 BACKGROUND

• Kondylakis H, Giglioli IAC, Katehakis D, Aldemir H, Zikas P, Papagiannakis G, Hors-Fraile S, Gonzalez-Sanz PL, Apostolakis K, Stephanidis C, Nunez-Benjumea FJ, Banos-Rivera RM, Fernandez-Luque L, Kouroubali A. Stress Reduction in Perioperative Care: Feasibility Randomized Controlled Trial. J Med Internet Res. 2025 Jan 7;27:e54049. doi: 10.2196/54049.

  PMID: 39773866 DERIVED

• Kondylakis H, Chicchi Giglioli IA, Katehakis DG, Aldemir H, Zikas P, Papagiannakis G, Hors-Fraile S, Gonzalez-Sanz PL, Apostolakis KC, Stephanidis C, Nunez-Benjumea FJ, Banos-Rivera RM, Fernandez-Luque L, Kouroubali A. A Digital Health Intervention for Stress and Anxiety Relief in Perioperative Care: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 29;11(11):e38536. doi: 10.2196/38536.

  PMID: 36445734 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Scoliosis; Prostatic Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Urinary Bladder Diseases

Study Officials

• Clara Hernández Cera

  Hospital San Joan de Deu

  PRINCIPAL INVESTIGATOR

• Ignacio Muñoz Carvajal

  Hospital Universitario Reina Sofía

  STUDY DIRECTOR

• Juan José Lázaro Alcay

  Hospital San Joan de Deu

  STUDY CHAIR

• Andrea Vallejo Tarrat

  Parc Taulí Hospital Universitari

  STUDY CHAIR

• JG Maessen, Prof. dr.

  Maastricht University Medical Center

  STUDY CHAIR

• Marco Dellabella

  Istituto di Ricovero e Cura per Anziani

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The SaMD CARINAE embeds the I-Change Model, which claims that behavioral changes depend on the inner motivation to perform a specific behavior and the self-perception of personal abilities, or self-efficacy perception, to carry out the behavioral change.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 11, 2022
• Study Start: January 10, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 31, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); IT (1); ES (3)