The effect of premedication on preoperative anxiety.
Memnune Pekcan, Bilge Celebioglu, Basaran Demir...
https://pubmed.ncbi.nlm.nih.gov/16438017Actively Recruiting
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-04-16
296
Participants Needed
4
Research Sites
13 weeks
Total Duration
Researchers are investigating how combining cardiac coherence, a guided breathing technique, with medical hypnosis may help reduce anxiety before surgery in cancer patients. This approach aims to offer a non-drug alternative to usual medications like benzodiazepines, which can have side effects, especially in older adults or those with heart or lung problems. The study focuses on patients undergoing oncological surgery who often experience significant stress during their treatment. Participants in the experimental group will be taught to perform cardiac coherence sessions at home using the Respirelax app, practicing three 5-minute sessions daily for 7 to 15 days before surgery. They may also listen to a hypnotic audio tape during or separate from these sessions. The control group will receive the standard preoperative care without these techniques. Throughout the study, patients will be assessed for anxiety levels using scales like the Visual Analogue Scale (VAS) and Amsterdam Preoperative Anxiety and Information Scale (APAIS) starting up to 15 days before surgery and on the day of surgery. Researchers will monitor recovery quality, pain levels, medication use, and hospitalization length. Patients will complete questionnaires and diaries to track their experience and adherence, with safety and postoperative outcomes also evaluated up to three months after surgery.
CONDITIONS
Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 15 days before surgery
Participants in the experimental group practice a cardiac coherence breathing program coupled with hypnosis at home before surgery to manage preoperative anxiety.
Daily home sessions (3 sessions per day, 5 minutes each)
Duration - Day of surgery
Participants undergo their planned oncological surgery under general or regional anesthesia.
1 visit (in-person, day of surgery)
Duration - From day after surgery up to 3 months
Participants are assessed for anxiety, pain, recovery quality, and medication use following surgery.
Assessments on Day 1, Day 2, and at 1, 2, and 3 months after surgery
Total: 4 locations
1
Institut régional du cancer de Montpellier
Montpellier, Hérault, France, 34298
Actively Recruiting
2
Centre Léon Bérard
Lyon, France
Actively Recruiting
3
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
Not Yet Recruiting
4
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
J
Jean-Pierre BLEUSE, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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