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Benefit of Hypnosis on Smartphone for Acute Post-operative Pain (HYPNO-APP)

Primary Purpose

Appendicitis With Peritonitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of hypnosis videos
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis With Peritonitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18 years and over Complicated acute appendicitis with generalized appendicitis, coelioscopy emergency surgery Signature of the written informed consent form by the patient Affiliation to a French health insurance scheme or equivalent Patient inderstands French and has a smartphone with internet access Non inclusion Criteria: Uncomplicated or complicated appendicitis of abscesses, presence of an intraperitoneal abscess, a plastron, uncomplicated appendicitis of generalized peritonitis Patient with a neurological, visual or auditory condition where videos cannot be viewed Presence of active cancer, a malignant hemopathy, drug addiction, coagulopathy, immunosuppressive treatment Non-acute or interval appendectomy, i.e. after antibiotic treatment of a complicated appendicitis of the plastron or drainage of an appendicular abscess; Vulnerable people: adult under guardianship, curator ship or deprived of freedom. Medication or pathology affecting ability to discern: Severe psychotic disorders Patient refusing to monitor anxiety and pain via smartphone Patient already medically monitored for anxiety, depressive or chronic pain syndrome

Sites / Locations

  • Nice University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypnosis video to control postoperative pain.

Arm Description

Outcomes

Primary Outcome Measures

To study the effect of hypnosis on smartphone on postoperative pain in patients operated in emergency by coelioscopy of acute and complicated appendicitis with peritonitis.
Efficacy of hypnosis on smartphone will be defined by the evolution of pain. Pain will be measured with a visual and analogic scale, before and after each hypnosis session. The scame ranges from 0 (no pain) to 10 (maximum thinkable pain).

Secondary Outcome Measures

To study the effect of hypnosis on smartphone on the use of analgesics during hospitalization.
A standardized analgesic protocol is implemented in order to each patient receives painkillers in the same way after inclusion. The amount of morphine received during hospitalization will be expressed as morphine equivalent.
To study the effect of hypnosis on smartphone on the average length of hospital stay after the beginning of hypnosis sessions
The length of hospitalization is the cumulative length of the entire hospital stay(s) in days until the 30th postoperative day (rehospitalizations included). The length of stay in a non-hospital health structure, such as a convalescent center, will not be included.
To study the effect of hypnosis on smartphone on the anxiety before and after hypnosis sessions
Anxiety will be measured using the Anxiety-State scale from Spielberger. It assesses the feelings of apprehension, tension, nervousness and worry that the subject feels at the time of the anxiety or the competitive situation. This questionnaire is an indicator of transient changes in anxiety caused by adverse or therapeutic situations. For each question, answers are ranged from 1 to 4. If the total score exceeds 51 for men, 61 for women, the patient is considered anxious.
To study the effect of hypnosis on smartphone on morbidity at postoperative day 30.
Morbidity will be classified according to the Clavien-Dindo classification. This classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death).

Full Information

First Posted
April 27, 2023
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05854914
Brief Title
Benefit of Hypnosis on Smartphone for Acute Post-operative Pain (HYPNO-APP)
Official Title
Benefit of Hypnosis on Smartphone for Acute Post-operative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Appendicitis is a common pathology and the one of the most common surgical procedures performed in France. Young subjects are the most frequent patients with appendicitis. Appendicular peritonitis increases post-operative pain, morbidity, and the average length of hospital stay compared to uncomplicated appendicitis. Pain alters perioeprative rehabilitation of patients. Surgery, performed urgently, generates more anxiety and pain than scheduled surgery. But, intensity of chronic postoperative pain is in correlation to intensity of acute postoperative pain. In addition, admission of emergency cases is more axiety-inducing, due to wait times, packed emergency room, worklaod of medical staff. Sex and age also modify perception of postoperative pain. Adults under 50 feel more pain than older patients for similar procedures. Medication for pain is required in perioperative period et is administered according protocol of each medical center ; these protocols include analgesics, opioids or not, benzodiazepine... However, opioids analgesic (example: morphine) can induce side effect, such as confusional syndrome, cardio-pulmonary manifestations, ileus, nausea and vomiting... Non-pharmacological approaches have been also proposed to reduce anxiety and pain. Hypnosis is frequently used but not always adapted to the emergency: need for qualified and available staff, environment not conducive to hypnotic induction... Hypnosis is a modified state of consciousness ; it is neither a state of vigilance nor a state of sleep. Several types of hypnosis can be distinguished according to the medical application, such as hypnoanalgesia or hypnosedation. Using hypnosedation during surgical or invasive procedure can reduce the use of painkillers and sedatives. Interest of hypnosis has been observed for extraction of wisdow teeth, delivery... Young patients are very comfortable with the use of their smartphone which is often the first object recovered when they return from the operating room. Many hypnosis videos are available free of charge on Internet, and some of which are produced by specialized practitioners and university teachers. A recent study has shown that among young people, addiction to smartphone is a predisposition to hypnosis. However, the use of hypnosis videos on smartphone has never been studied for the control of postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis With Peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis video to control postoperative pain.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Use of hypnosis videos
Intervention Description
Hypnosis on smartphone will be used to manage pain for emergent coelioscopy surgery of patients with acute and complicated appendicitis, with generalized peritonitis
Primary Outcome Measure Information:
Title
To study the effect of hypnosis on smartphone on postoperative pain in patients operated in emergency by coelioscopy of acute and complicated appendicitis with peritonitis.
Description
Efficacy of hypnosis on smartphone will be defined by the evolution of pain. Pain will be measured with a visual and analogic scale, before and after each hypnosis session. The scame ranges from 0 (no pain) to 10 (maximum thinkable pain).
Time Frame
During the first postoperative week
Secondary Outcome Measure Information:
Title
To study the effect of hypnosis on smartphone on the use of analgesics during hospitalization.
Description
A standardized analgesic protocol is implemented in order to each patient receives painkillers in the same way after inclusion. The amount of morphine received during hospitalization will be expressed as morphine equivalent.
Time Frame
30 days post surgery
Title
To study the effect of hypnosis on smartphone on the average length of hospital stay after the beginning of hypnosis sessions
Description
The length of hospitalization is the cumulative length of the entire hospital stay(s) in days until the 30th postoperative day (rehospitalizations included). The length of stay in a non-hospital health structure, such as a convalescent center, will not be included.
Time Frame
30 days post surgery
Title
To study the effect of hypnosis on smartphone on the anxiety before and after hypnosis sessions
Description
Anxiety will be measured using the Anxiety-State scale from Spielberger. It assesses the feelings of apprehension, tension, nervousness and worry that the subject feels at the time of the anxiety or the competitive situation. This questionnaire is an indicator of transient changes in anxiety caused by adverse or therapeutic situations. For each question, answers are ranged from 1 to 4. If the total score exceeds 51 for men, 61 for women, the patient is considered anxious.
Time Frame
At inclusion and 2 days after inclusion
Title
To study the effect of hypnosis on smartphone on morbidity at postoperative day 30.
Description
Morbidity will be classified according to the Clavien-Dindo classification. This classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death).
Time Frame
30 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years and over Complicated acute appendicitis with generalized appendicitis, coelioscopy emergency surgery Signature of the written informed consent form by the patient Affiliation to a French health insurance scheme or equivalent Patient inderstands French and has a smartphone with internet access Non inclusion Criteria: Uncomplicated or complicated appendicitis of abscesses, presence of an intraperitoneal abscess, a plastron, uncomplicated appendicitis of generalized peritonitis Patient with a neurological, visual or auditory condition where videos cannot be viewed Presence of active cancer, a malignant hemopathy, drug addiction, coagulopathy, immunosuppressive treatment Non-acute or interval appendectomy, i.e. after antibiotic treatment of a complicated appendicitis of the plastron or drainage of an appendicular abscess; Vulnerable people: adult under guardianship, curator ship or deprived of freedom. Medication or pathology affecting ability to discern: Severe psychotic disorders Patient refusing to monitor anxiety and pain via smartphone Patient already medically monitored for anxiety, depressive or chronic pain syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MASSALOU Damien
Phone
04 92 03 33 13
Ext
+33
Email
massalou.d@chu-nice.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MASSALOU Damien
Phone
0492033313
Ext
+33
Email
massalou.d@chu-nice.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Benefit of Hypnosis on Smartphone for Acute Post-operative Pain (HYPNO-APP)

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