Clinical trial NCT05204043: Peter Hess® Sound Massage for Reducing Anxiety and Pain in Cardiac Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Pain, Postoperative
Pain, Chest
Anxiety
Anxiety Postoperative
Thoracic Surgery
Keywords: Peter Hess
Music Care
Sound massage
sound therapy
music therapy
singing bowls
vibrations
relaxation
coronary bypass
cardiac surgery
cardiology
music
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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)

Eligibility criteria: Inclusion Criteria:

1. Patients between 40 and 70 years old
2. Hospitalized for a coronary bypass
3. That has given his written consent
4. Affiliated to a French social security system or entitled to a social security benefit.

Exclusion Criteria:

1. Emergency coronary bypass surgery
2. Impaired ventricular function (ejection fraction \< 45%)
3. Combined surgery
4. Patient with chronic dialysis
5. Diagnosed with severe depression
6. Patient in a psychotic state
7. Patient with chronic pain
8. Patient incapable of giving his written consent
9. Patient deprived of liberty by judicial decision or benefiting from legal protection (under guardianship or curatorship)
10. Patient on AME
11. Participation in other interventional research involving humans, or being in the period of exclusion from previous research involving humans, if applicable.
12. Pregnant or breastfeeding woman
13. Patient with pacemaker
14. Patient with implanted metallic medical devices
15. Recently operated patient
16. Patient with hearing epilepsy
17. Tinnitus patient

Primary outcomes:
measure: State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients
timeFrame: At Day7 (after surgery)
Secondary outcomes:
measure: State Trait Anxiety Inventory (STAI-A) score, in each group
timeFrame: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
measure: Consumption of anxiolytic drugs
timeFrame: Through study completion, an average of 7 days
measure: Pain assessment
timeFrame: At Day-1, Day2, Day3, Day4 and Day7.
measure: Consumption of antalgics
timeFrame: Through study completion, an average of 7 days
measure: Consumption of anti-inflammatory
timeFrame: Through study completion, an average of 7 days
measure: Demand of care in physiotherapy
timeFrame: Through study completion, an average of 7 days
measure: Blood pressure
timeFrame: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
measure: Cardiac frequency
timeFrame: At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
measure: Length of hospitalisation
timeFrame: At Day7 (end of participation)
measure: Sides effect
timeFrame: Through study completion, an average of 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pascal LEPRINCE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: