Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
About this trial
The investigator proposes to use the cardiac coherence technique to diminish anxiety before the surgery of a peritoneal carcinosis of colon or stomach or ovary and pseudomyxoma or peritoneal mesothelioma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Patients with peritoneal carcinosis awaiting cytoreductive surgery
Patients who scored strictly above 3 on the visual analogue anxiety scale and/or the psychological distress scale
Patients with sufficient command of the French language
Disqualifiers
Patients who already have daily practice of cardiac coherence
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
Physical or sensory inability to respond to questionnaires
Patients who have had a heart transplant or bypass surgery in the Year before surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Cardiac coherence
Other interventionAn initiation session to cardiac coherence will take place D-11 before the operation (during the surgical consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape. 3 cardiac coherence sessions per day of 5 min (before meals) during the 11 days preceding the operation. \- The program cardiac coherence will be performed during 90 days after the surgery
Standard care
Other interventionStandard care
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Coherence cardiacExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cardiac Coherence Program Adherence Rate
Cardiac Coherence Program Adherence Rate. Patients are considered in "success" adhere to the program) if they will perform at least 20 of the 30 sessions scheduled until surgery (minimum 1 practice per day).
Time frame
Around 10 daysSecondary outcomes
1
Anxiety by using the visual analogue scale (VAS)
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 anxiety and the position on the right an unbearable anxiety.
Time frame
90 days2
Anxiety and depression by using the hospital anxiety and depression scale (HADS)
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)
Time frame
90 days3
Psychological distress scale
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.
Time frame
90 days4
Generalized anxiety by using Freeston's uncertainty tolerance scale
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)
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov