NCT05204043

Peter Hess® Sound Massage for Reducing Anxiety and Pain in Cardiac Surgery

Peter Hess® Sound Massage Versus Music Care® Relaxation for the Management of Anxiety and Pain in Patients Undergoing Coronary Artery Bypass Surgery in Thoracic and Cardiovascular Surgery: a Comparative Controlled and Randomised Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery. Music Care® relaxation technique consists into listening to an audio relaxing soundtrack chosen by the patient. This technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital. The research consists of comparing this technique to Peter Hess® sound massage for reducing pain and anxiety. The Peter Hess® sound massage is a holistic relaxation technique that uses sound vibrations generated by therapeutic singing bowls. Patients will be randomized in one of the two groups (Music Care® or Peter Hess®).

Detailed description

* Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery. * Design of the study: Controlled randomized single blind clinical trial / Interventional research protocol implying human being that doesn't involve any health product * Patients will be randomized in one of the two following groups: 1. Peter Hess® sound massage, a relaxation technic using singing bowls' sound vibrations The Peter Hess® sound massage is a holistic relaxation technique (body and mind) that uses sound vibrations generated by therapeutic singing bowls. Its efficiency and adaptability make it a complementary method that can be pertinent for many hospital departments, both for patients and caregivers. 2. Music Care® relaxation technique, a validated Non-Medicinal Intervention which is a pyscho-musical relaxation technique using audio relaxation music diffused in dedicated headphone. The audio relaxing soundtracks are chosen by the patient. Music Care® technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital. * Main Objective: Prove a better efficiency of the Peter Hess® sound massage for reducing anxiety compared to Music Care® relaxation technique. * Main criteria: difference between the two groups on anxiety scores' variation (measured by STAI) between preoperative visit (J-1) and postoperative visit (J+7)

Conditions

• Pain
• Pain, Postoperative
• Pain, Chest
• Anxiety
• Anxiety Postoperative
• Thoracic Surgery

Interventions

Type	Name	Description
OTHER	Peter Hess® sound massage	The Peter Hess® sound massage uses sound vibrations generated by therapeutic singing bowls. Peter Hess' methods act far from a traumatised area, far from the pain. It will be given on the patient's bed for 30 minutes.
OTHER	Music relaxation Music Care®	The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes.
OTHER	Questionnaires	* State Trait Anxiety Inventory (STAI) * Pain assessment - Visual Analogic Scale (from 0 to 10).

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-01-24
• Last updated: 2022-01-24