Psychological StressCARINAENCT05184725
CARINAE for Stress Relief in Perioperative Care
A study testing SaMD CARINAE in people with Psychological Stress and Cardiopulmonary Bypass Surgery, run by Adhera Health, Inc. at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery
- What is being tested?
- SaMD CARINAE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Jan 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain3 sites
Hospital Reina Sofía
Córdoba, Andalusia, 14004
Hospital San Joan de Deu
Esplugues de Llobregat, Catalonia, 08950
Hospital Parc Taulí
Sabadell, Catalonia, 08208
About this study
Official title: CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study
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.
Read the detailed description
Patients will be randomly assigned to intervention group or the control group. Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately. The intervention trial will include a total of 4 visits: 1. Recruitment; 2. Hospital admission; 3. Hospital discharge; 4. Post-operative follow-up in 14 days.
SaMD CARINAE delivers the following interventions to the patients:
- Personalised patient-centred health education program to improve patient's condition and recovery self-management skills.
- Artificial Intelligence-based behaviour change program to promote healthier lifestyle habits.
- Personalised mental well-being coaching program to improve patient's ability to cope with emotional disturbances such as stress and anxiety.
- A collaborative digital support platform to enable information exchange between patients, caregivers, and healthcare professionals.
The program is delivered to patients and caregivers as a SaMD mHealth application (smartphone app) and an immersive environment with a VR device. Healthcare professionals will be able to access the collaborative digital support platform through a web application.
Finally, the control group will not be exposed to SaMD CARINAE solution, following the traditional routine visits, and after each traditional visit patients will answer to questionnaires specified in the secondary outcome measures section.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement, Hip Replacement, Orthognathic Surgery
- Being tested
- SaMD CARINAE
- 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)
- Medical subject headings
- Stress, Psychological, Scoliosis, Prostatic Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaMD CARINAEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SaMD CARINAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 45 days: From baseline to hospital discharge
Secondary outcomes (4)
System Usability Scale
Questionnaire on SaMD CARINAE usability by patients, caregivers and healthcare professionals
Measured: 30 days: from hospital admission to 14 days after surgery
Usability questionnaire
Ad-hoc questionnaire for patients and healthcare professional on the digital solution usability
Measured: 30 days: from hospital admission to 14 days after surgery
Net Promoter Score
Net Promoter Score (NPS) is a questionnaire that measures patient and healthcare professionals experience and provides the core measurement for customer experience management programs.
Measured: 30 days: from hospital admission to 14 days after surgery
Reliability
Ad-Hoc questionnaire for the healthcare professional on the digital solution
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start10 Jan 2022
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adhera Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University Medical Center, Hospital Sant Joan de Deu, Parc Taulí Hospital Universitari, Hospital Universitario Reina Sofia de Cordoba, Istituto Nazionale di Ricovero e Cura per Anziani
- Responsible party
- Sponsor
- Investigators
- Clara Hernández Cera, Principal investigator, Hospital San Joan de DeuIgnacio Muñoz Carvajal, Study director, Hospital General Universitario Reina Sofía de MurciaJuan José Lázaro Alcay, Study chair, Hospital San Joan de DeuAndrea Vallejo Tarrat, Study chair, Parc Taulí Hospital UniversitariJG Maessen, Prof. dr., Study chair, Maastricht University Medical CenterMarco Dellabella, Study chair, Istituto di Ricovero e Cura per Anziani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184725
- Sponsor's protocol ID
- CAR-0320
- Acronym
- CARINAE
- Status last verified
- Jul 2022
- First submitted
- 29 Nov 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crichton, N. Visual analogue scale (VAS). J Clin Nurs. 2001; 10(5): 706-6.
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.
PubMed 6880820Watson 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.
PubMed 3397865Stewart-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.
PubMed 19228398Schwarzer, 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.
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.
PubMed 15230939Brooke, J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996; 189(194): 4-7.
Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124.
PubMed 14712543Kondylakis 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.
PubMed 39773866Kondylakis 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.
PubMed 36445734
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study
- ClinicalTrials.gov ID
- NCT05184725
- Acronym / sponsor ID
- CARINAE / CAR-0320
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement, Hip Replacement, Orthognathic Surgery
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Adhera Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University Medical Center, Hospital Sant Joan de Deu, Parc Taulí Hospital Universitari, Hospital Universitario Reina Sofia de Cordoba, Istituto Nazionale di Ricovero e Cura per Anziani
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be randomly assigned to intervention group or the control group. Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately. The intervention trial will include a total of 4 visits: 1. Recruitment; 2. Hospital admission; 3. Hospital discharge; 4. Post-operative follow-up in 14 days.
SaMD CARINAE delivers the following interventions to the patients:
- Personalised patient-centred health education program to improve patient's condition and recovery self-management skills.
- Artificial Intelligence-based behaviour change program to promote healthier lifestyle habits.
- Personalised mental well-being coaching program to improve patient's ability to cope with emotional disturbances such as stress and anxiety.
- A collaborative digital support platform to enable information exchange between patients, caregivers, and healthcare professionals.
The program is delivered to patients and caregivers as a SaMD mHealth application (smartphone app) and an immersive environment with a VR device. Healthcare professionals will be able to access the collaborative digital support platform through a web application.
Finally, the control group will not be exposed to SaMD CARINAE solution, following the traditional routine visits, and after each traditional visit patients will answer to questionnaires specified in the secondary outcome measures section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: SaMD CARINAEIntervention 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaMD CARINAESaMD 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. | Device | SaMD CARINAE |
Primary outcome
Visual Analog Scale for Stress
Time frame: 2 months: from baseline to 14 days after the surgery
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.
Visual Analog Scale for Pain
Time frame: 2 months: from baseline to 14 days after the surgery
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.
Hospital Anxiety and Depression Scale
Time frame: 45 days: From hospital admission to 14 days after the surgery
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.
Health-related Quality of Life - EQ-5D-3L/-Y
Time frame: 45 days: From hospital admission to 14 days after the surgery
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.
The Positive and Negative Affect Schedule
Time frame: 45 days: From hospital admission to 14 days after the surgery
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.
The Short Warwick-Edinburgh Mental Well-Being Scale
Time frame: 2 months: from baseline to 14 days after the surgery
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.
General Self-Efficacy Scale
Time frame: 2 months: from baseline to 14 days after the surgery
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.
Patient Activation Measure
Time frame: 45 days: From baseline to hospital discharge
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.
4 secondary outcomes
System Usability Scale
Time frame: 30 days: from hospital admission to 14 days after surgery
Usability questionnaire
Time frame: 30 days: from hospital admission to 14 days after surgery
Net Promoter Score
Time frame: 30 days: from hospital admission to 14 days after surgery
Reliability
Time frame: Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- BackgroundCrichton, N. Visual analogue scale (VAS). J Clin Nurs. 2001; 10(5): 706-6.
- Background: PubMed 6880820Zigmond 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.
- Background: PubMed 3397865Watson 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.
- Background: PubMed 19228398Stewart-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.
- BackgroundSchwarzer, 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: PubMed 15230939Hibbard 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.
- BackgroundBrooke, J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996; 189(194): 4-7.
- Background: PubMed 14712543Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124.
- Derived from this study: PubMed 39773866Kondylakis 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.
- Derived from this study: PubMed 36445734Kondylakis 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.
- Individual participant dataSharing planned: No
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Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Hernández Cera principal investigator
Hospital San Joan de Deu
Ignacio Muñoz Carvajal study director
Hospital General Universitario Reina Sofía de Murcia
Juan José Lázaro Alcay study chair
Hospital San Joan de Deu
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaMD CARINAE in people with Psychological Stress and Cardiopulmonary Bypass Surgery, run by Adhera Health, Inc. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Stress (time frame: 2 months: from baseline to 14 days after the surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184725, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.