Clinical trial NCT05824598: Multifunctional Approach in Cardiac Surgery
Official title: OsteopaThic, logopedIc and Psychological Assessment To Improve Outcome in pAtieNts undergoIng Cardiac Surgery: a Randomized Clinical Trial (TITANIC Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Keywords: cardiac surgery
cardiac rehabilitation
swallowing disorders
post-surgical pain
psychological counseling
osteopathic manipulative treatment
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain release through the Brief Pain Inventory
timeFrame: Through study completion, an average of 4 weeks
measure: Anxiety and depression control through the Hospital Anxiety and Depression Scale
timeFrame: Through study completion, an average of 4 weeks
Secondary outcomes:
measure: To assess functional swallowing disorders post-cardiac surgery (Mealtime Assessment Scale)
timeFrame: Through study completion, an average of 4 weeks
measure: Anti-inflammatory drugs use (numbers of pills used)
timeFrame: Through study completion, an average of 4 weeks
measure: LOS
timeFrame: Through study completion, an average of 4 weeks
measure: Number of participants with persistent inflammatory status
timeFrame: Through study completion, an average of 4 weeks
measure: Adherence to treatment
timeFrame: Through study completion, an average of 4 weeks
measure: Quality of life improvement through the EuroQol Visual Analogue Scale (EuroQoL-VAS) questionnaire
timeFrame: Through study completion, an average of 4 weeks
measure: Cognitive impairment
timeFrame: Through study completion, an average of 4 weeks
measure: Quality of life improvement through the Short Form-12 (SF-12) questionnaire
timeFrame: Through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Gnocchi, ONLUS
Study officials:
References: