Heart; Surgery, Heart, Functional Disturbance as Result
Conditions
Keywords
cardiac surgery, cardiac rehabilitation, swallowing disorders, post-surgical pain, psychological counseling, osteopathic manipulative treatment
Brief summary
Postoperative pain and swallowing disorders are complex, multifactorial phenomenon that frequently occur after cardiac surgery. Preoperative anxiety and the interaction between sex and other sociocultural factors may predict greater sensitivity to postoperative pain, whereas the epidemiology and course of swallowing disorders has not been systematically investigated, along with the interaction between dysphagia, post-operative pain and emotional stress. Cardiac rehabilitation is a multifunctional intervention which may address all these functional domains, improving patients' prognosis. The aim of the present study is to demonstrate the superiority of a multifunctional approach (OMT, systematic swallowing screening and specific treatment according to good clinical practice associated with psychological counseling) compared to local clinical practice in the management of pain and swallowing disorders.
Detailed description
The TITANIC trial will provide evidence on whether a multifunctional intervention systematically implemented in the cardiac rehabilitation setting will improve the clinical course and prognosis of patients with recent cardiac surgery. The design is a randomized clinical trial with parallel group design. Patients aged over 18 undergoing elective cardiac surgery and admitted to IRCCS Fondazione Don Gnocchi, Santa Maria Nascente, Milan, for cardiac rehabilitation will be randomized to standard post-acute treatments (cardiovascular training, monitoring and logopedic treatment only in case of swallowing dysfunction) compared with an experimental approach which consists of osteopathic manipulative treatment (OMT) treatments, swallowing screen protocol, psychological assessment and counseling. This study may help in the identification of a new diagnostic-therapeutic pathway in cardiac surgery patients that allows a reduction in the use of analgesics and anti-inflammatories and increases the early detection of swallowing disorders. Furthermore, by allowing an integrated assessment of emotional needs, it can have a positive effect in reducing the need for post-operative clinical visits and assessments in the medium to long term, improving the patients' quality of life.
Interventions
BEHAVIORALMultifunctional rehabilitation treatment
multidisciplinary approach with (OMT, psychological counseling, and therapists dedicated to swallowing disorders)
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The pain scores will be assessed by a psychologist blinded to group allocation
Intervention model description
Monocentric, single blind with parallel arm design. Standard descriptive analysis and linear and logistic regression models will be performed. To correct any imbalances between the 2 groups due to the low sample size, an analysis adjusted for the main confounders listed below is planned: age, gender, previous cognitive impairment, previous presence of anxiety and depression beyond the clinically acceptable threshold. Sample size estimation was performed using G\*Power v3.1 software. The sample size was calculated separately for the two outcomes of interest that will make up the composite score: reduction in pain assessed using the Numerical Rating Scale (NRS) and reduction in anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS). It was then decided to conservatively adopt the higher number of the two estimates.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(all the following must be satisfied): * patients with recent cardiac surgery (within one month) * without swallowing disorders already identified before discharge * with the presence of chest pain (NRS\>2).
Exclusion criteria
* patients who are unable to sign informed consent. * patients with already known psychological/psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain release through the Brief Pain Inventory | Through study completion, an average of 4 weeks | To verify the effectiveness of the multifunctional rehabilitation approach in reducing pain assessed by the Brief Pain Inventory: likert scale with maximum pain intensity equal to 7-10. |
| Anxiety and depression control through the Hospital Anxiety and Depression Scale | Through study completion, an average of 4 weeks | To verify the effectiveness of the multifunctional rehabilitation approach in reducing anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), with maximum anxiety and depression equal to 15-21 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LOS | Through study completion, an average of 4 weeks | Length of stay |
| Number of participants with persistent inflammatory status | Through study completion, an average of 4 weeks | The persistent inflammatory status will be described in terms of fever and PCR\> 5 in at least two successive measurements 8 days apart) |
| Adherence to treatment | Through study completion, an average of 4 weeks | Monitoring of adherence to treatment using the 4-item Morisky, Green, and Levine Adherence Scale. With a sum of scores of 8, from 6 to \<8 or \<6, patients can be classified as having high, medium or low adherence to therapy, respectively. |
| To assess functional swallowing disorders post-cardiac surgery (Mealtime Assessment Scale) | Through study completion, an average of 4 weeks | Epidemiological framework of the cardiac surgery population, in terms of presence/absence of swallowing disorders. MAS: points 0-36, with higher scores defining the worst outcome. |
| Cognitive impairment | Through study completion, an average of 4 weeks | Monitoring of cognitive abilities through the administration of the Montreal Cognitive Assessment Test (MOCA) scale, with a score more than 17,54 in the normal range. A raw and then corrected score: - less than 15.5 suggests the presence of a cognitive impairment; \- between 15.5 and 17.54 assumes a borderline performance; - a score above 17.54 would show functioning within the normal range. |
| Quality of life improvement through the Short Form-12 (SF-12) questionnaire | Through study completion, an average of 4 weeks | Scores can be reported as Z-scores (difference from the population mean, measured in standard deviations). The population mean is 50 points. The population standard deviation is 10 points. Thus, each 10-point increase above or below 50 is one standard deviation from the mean. |
| Quality of life improvement through the EuroQol Visual Analogue Scale (EuroQoL-VAS) questionnaire | Through study completion, an average of 4 weeks | Consisting of two parts. The first explores 5 areas of interest: mobility, personal hygiene, social activities, pain and anxiety/depression. Each individual area has, in turn, three levels of severity (no problem, problem of some size, problem of extreme seriousness). The second section consists of a 20 cm visual analog scale (VAS) on which the patient indicates the best (score=0) or worst (score=100) possible state of health. |
| Anti-inflammatory drugs use (numbers of pills used) | Through study completion, an average of 4 weeks | Monitoring the use of anti-inflammatory drugs |
Countries
Italy
Outcome results
None listed