OsteopaThic, logopedIc and Psychological Assessment To Improve Outcome in pAtieNts undergoIng Cardiac Surgery: a Randomized Clinical Trial (TITANIC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain release through the Brief Pain Inventory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The pain scores will be assessed by a psychologist blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •patients who are unable to sign informed consent.
- •patients with already known psychological/psychiatric disorders.
研究组 & 干预措施
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).
干预措施: Multifunctional rehabilitation treatment (Behavioral)
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).
结局指标
主要结局
Pain release through the Brief Pain Inventory
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Quality of life improvement through the EuroQol Visual Analogue Scale (EuroQoL-VAS) questionnaire(Through study completion, an average of 4 weeks)
- Quality of life improvement through the Short Form-12 (SF-12) questionnaire(Through study completion, an average of 4 weeks)
- Cognitive impairment(Through study completion, an average of 4 weeks)