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Completed

NCT Number: NCT05824598

Multifunctional Approach in Cardiac Surgery

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.

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Key information

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Gnocchi, ONLUS

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multifunctional rehabilitation treatment

Behavioral

multidisciplinary approach with (OMT, psychological counseling, and therapists dedicated to swallowing disorders)

Primary outcomes

  1. Pain release through the Brief Pain Inventory

    Time frame: 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.

  2. Anxiety and depression control through the Hospital Anxiety and Depression Scale

    Time frame: 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 outcomes

  1. To assess functional swallowing disorders post-cardiac surgery (Mealtime Assessment Scale)

    Time frame: 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.

  2. Anti-inflammatory drugs use (numbers of pills used)

    Time frame: Through study completion, an average of 4 weeks

    Monitoring the use of anti-inflammatory drugs

  3. LOS

    Time frame: Through study completion, an average of 4 weeks

    Length of stay

  4. Number of participants with persistent inflammatory status

    Time frame: 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)

  5. Adherence to treatment

    Time frame: 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.

  6. Quality of life improvement through the EuroQol Visual Analogue Scale (EuroQoL-VAS) questionnaire

    Time frame: 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.

  7. Cognitive impairment

    Time frame: 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.

  8. Quality of life improvement through the Short Form-12 (SF-12) questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

OsteopaThic, logopedIc and Psychological Assessment To Improve Outcome in pAtieNts undergoIng Cardiac Surgery: a Randomized Clinical Trial (TITANIC Trial)

Acronym: TITANIC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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