Multifunctional Approach in Cardiac Surgery

NCT05824598 | Completed

• 1 other identifier: 06_08/02/2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Keywords

cardiac surgery; cardiac rehabilitation; swallowing disorders; post-surgical pain; psychological counseling; osteopathic manipulative treatment

Outcome Measures

Primary Outcomes (2)

• Pain release through the Brief Pain Inventory

  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.

  Through study completion, an average of 4 weeks

• Anxiety and depression control through the Hospital Anxiety and Depression Scale

  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.

  Through study completion, an average of 4 weeks

Secondary Outcomes (8)

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

  Through study completion, an average of 4 weeks

• Anti-inflammatory drugs use (numbers of pills used)

  Through study completion, an average of 4 weeks

• LOS

  Through study completion, an average of 4 weeks

• Number of participants with persistent inflammatory status

  Through study completion, an average of 4 weeks

• Adherence to treatment

  Through study completion, an average of 4 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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).

Behavioral: Multifunctional rehabilitation treatment

Controls

NO INTERVENTION

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).

Interventions

Multifunctional rehabilitation treatment BEHAVIORAL

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with recent cardiac surgery (within one month)
• without swallowing disorders already identified before discharge
• with the presence of chest pain (NRS\>2).

You may not qualify if:

• patients who are unable to sign informed consent.
• patients with already known psychological/psychiatric disorders.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Gnocchi, ONLUS

Milan, Italy

Location

MeSH Terms

Conditions

Deglutition Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pain scores will be assessed by a psychologist blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 21, 2023
• Study Start: May 15, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)