Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2023-05-15
2023-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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Treatment
The cases (active treatment) will be treated with an approach that includes osteopathic treatment for pain control (by the Osteopath Bruno Bordoni), systematic swallowing screening (Speech Therapist, Leone Stilo), psychological counseling (Psychologist, Eleonora Volpato, Giulia Novembre ). The duration of treatment will be that of hospitalization, on average about 3 weeks. The osteopathic treatment will last 5 sessions, while the counseling will have one session at the admission and one at the discharge and up to two sessions a week (variable according to individual needs); the swallowing screening will have one session at the admission and one at discharge and about two-three sessions a week (variable according to individual needs).
Multifunctional rehabilitation treatment
multidisciplinary approach with (OMT, psychological counseling, and therapists dedicated to swallowing disorders)
Controls
Controls will follow good clinical practice (in this case systematic screening from a swallowing point of view will not be applied, nor will osteopathic treatment and systematic psychological counseling be considered).
No interventions assigned to this group
Interventions
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Multifunctional rehabilitation treatment
multidisciplinary approach with (OMT, psychological counseling, and therapists dedicated to swallowing disorders)
Eligibility Criteria
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Inclusion Criteria
* without swallowing disorders already identified before discharge
* with the presence of chest pain (NRS\>2).
Exclusion Criteria
* patients with already known psychological/psychiatric disorders.
18 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Locations
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IRCCS Fondazione Don Gnocchi, ONLUS
Milan, , Italy
Countries
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Other Identifiers
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06_08/02/2023
Identifier Type: -
Identifier Source: org_study_id
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