Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis (COCOON)

Primary Outcome Measures Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire [ Time Frame: 90 days ]State anxiety reflects the current emotional state, which allows the patient’s nervousness and worry to be assessed during the session. The range is from 20 (lower anxiety) to 80 (higher anxiety). The patient must answer 20 more

Primary Outcome Measures

  1. Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire [ Time Frame: 90 days ]State anxiety reflects the current emotional state, which allows the patient’s nervousness and worry to be assessed during the session. The range is from 20 (lower anxiety) to 80 (higher anxiety). The patient must answer 20 questions for each part, each answer being on a 4 point Likert scale.
  2. Subjective anxiety score by using the state-trait anxiety inventory form B (STAI-Y form B) questionnaire [ Time Frame: 90 days ]Trait anxiety reflects the usual emotional state. The range is from 20 (lower anxiety) to 80 (higher anxiety).The patient must answer 20 questions for each part, each answer being on a 4 point Likert scale

Secondary Outcome Measures

  1. Anxiety by using the visual analogue scale (VAS) [ Time Frame: 90 days ]This scale measures the anxiety of patient. It’s a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a (usually) 10 cm line. The points at which respondents make their mark represent where they perceive their answer to lie in this continuum. The distance between their mark and one end (or the mid-point) of the scale is recorded. The position on the left being the absence of pain and the position on the right an unbearable pain.
  2. Anxiety and depression by using the hospital anxiety and depression scale (HADS) [ Time Frame: 90 days ]One subscale for evaluation of anxiety from 0 (lower anxiety) to 21 (higher anxiety) and the other subscale for depression from 0 (lower anxiety) to 21 (higher depression)
  3. Psychological distress scale [ Time Frame: 90 days ]This scale measures the psychological distress of the patient . Psychological distress is characterized by the presence of symptoms, most often depressive or anxious.It’s a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a line. The position of the mark on the top is the higher psychological distress and at the bottom the lower psychological distress.
  4. Generalized anxiety by using Freeston’s uncertainty tolerance scale [ Time Frame: 90 days ]The scale is used to identify people with generalized anxiety disorder compared to people with other anxiety disorders or people without pathologies. Range is from 27 (lower uncertainty) to 135 (higher uncertainty)
  5. Heart rate variability [ Time Frame: 90 days ]The heart rate variability is determined by using the software EmWave Pro which measures the ratio low frequencies/high frequencies.
  6. Quality of life by using the quality of life questionnaire core (QLQ-C30) [ Time Frame: 90 days ]The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 (“Not at all”), 2 (“A little”), 3 (“Quite a bit”) and 4 (“Very much”). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 (“very poor”) to 7 (“excellent”). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
  7. Number of days of hospitalization [ Time Frame: 1 month ]
  8. Concentration of Cortisol [ Time Frame: 90 days ]
  9. Concentration of immunoglobulin A [ Time Frame: 90 days ]
  10. frequency and practice of cardiac coherence [ Time Frame: 20 days ]
  11. Preliminary costs of the cardiac coherence program [ Time Frame: 90 days ]
  12. Proportion of patients who have participated in the cardiac coherence program [ Time Frame: 90 days ]
  13. Number of patients not participating in the cardiac coherence program [ Time Frame: 90 days ]
  14. Number of patients satisfied with the cardiac coherence program [ Time Frame: 90 days ]

Inclusion Criteria

  1. Age over 18 years old
  2. Peritoneal Carcinosis Patients Waiting for colorectal cancer (CRC)
  3. Patients who scored strictly above 3 on the visual analogue scale (VAS) of anxiety and/or the psychological distress scale
  4. Volunteers to follow the cardiac coherence program
  5. Signing of informed consent after informed information given by the surgeon

Exclusion Criteria

  1. Patients who already have daily practice in cardiac coherence or other relaxation methods
  2. Presence of proven psychiatric disorders (e.g., mental retardation, psychotic disorders, learning disabilities, attention deficit/hyperactivity, bipolar disorder, etc.) other than mood disorders that are reactive to the disease experience, or receiving psychotic treatment that may impair thinking, judgment or discernment skills
  3. Physical or sensory inability to respond to questionnaires
  4. Legal incapacity or limited legal capacity (under guardianship).

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: July 19th, 2019.

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Last update: May 07, 2019. 08:38:48 pm.