Contribution of Hypnotic Analgesia to Local Anesthesia During Bronchial Endoscopy.

NCT03703960 | Terminated

• 1 other identifier: GEORGES ADEMPU 2018
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Bronchial endoscopy (or bronchial fibroscopy) is an invasive diagnostic examination performed extremely frequently in the Pneumology department of the Dijon University Hospital, with an average of 1200 procedures per year. It allows the pneumologist to see the first divisions of the bronchial tree but also to take samples for microbiological or anatomopathological purposes. The two main sampling techniques are bronchoalveolar lavage and endobronchial biopsies. Two steps in the process can be unpleasant for the patient:

1. 1.the crossing of the nasopharynx because of the narrow and curving passage,
2. 2.the crossing of the vocal cords and exploration of the trachea, which sometimes causes nausea but especially a cough and a feeling of suffocation.

Conditions

Patient With Bronchial Endoscopy

Outcome Measures

Primary Outcomes (1)

• score for the sensory component of dyspnea

  Comparison of the evolution of the score assigned to the sensory component of dyspnea measured by the Multidimensional Dyspnea Profile (MDP) scale before and after bronchial endoscopy between patients of the interventional arm 1 under local anesthesia and hypnotic analgesia, patients of the interventional arm 2 under local anesthesia and relaxing music and patients of the control arm under LA bronchial endoscopy.

  through study completion, an average of 30 minutes

Study Arms (3)

Group 1 "Hypnosis"

EXPERIMENTAL

Other: hypnotic analgesia

Group 2 "music"

ACTIVE COMPARATOR

Other: music

Control group

NO INTERVENTION

Interventions

hypnotic analgesia OTHER

classic three-step hypnosis procedure (induction, trance and return to consciousness).

Group 1 "Hypnosis"

music OTHER

calm music conducive to relaxation

Group 2 "music"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person who has given oral consent
• Patient having:
• a bronchial endoscopy for diagnostic purposes,
• performed on schedule in the Pneumology Department and Intensive Respiratory Care at the Dijon University Hospital
• regardless of the indication or samples taken during the examination (simple exploration, lavage, biopsies)

You may not qualify if:

• Person not affiliated to a national health insurance system
• Person subject to legal protection (curatorship, guardianship)
• Person under judiciary protection
• Non-menopausal woman
• Adult unable or unwilling to consent
• Minor
• Patient who does not speak French
• Patient with severe hearing disorder that make it difficult to perform hypnosis under good conditions
• Patient with psychiatric or neurological disorders such as dementia, psychosis or profound mental retardation
• Severe COPD requiring long-term oxygen therapy at home or with a tracheotomy
• Patient undergoing bronchial endoscopy for the management of acute respiratory distress

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: December 10, 2018
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

FR (1)