Appendicitis With PeritonitisNCT05854914
Benefit of Hypnosis on Smartphone for Acute Post-operative Pain (HYPNO-APP)
A study testing Use of hypnosis videos in people with Appendicitis With Peritonitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis With Peritonitis
- What is being tested?
- Use of hypnosis videos
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital
Nice, 06200
MASSALOU Damien, 0492033313 ext. +33, massalou.d@chu-nice.fr
About this study
Official title: Benefit of Hypnosis on Smartphone for Acute Post-operative Pain
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.
Read more
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.
- Conditions
- Appendicitis With Peritonitis
- Being tested
- Use of hypnosis videos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of hypnosis videosProcedure or surgery
Hypnosis on smartphone will be used to manage pain for emergent coelioscopy surgery of patients with acute and complicated appendicitis, with generalized peritonitis
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis video to control postoperative pain. | Experimental | Not described Receives: Procedure: Use of hypnosis videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the first postoperative week
Secondary outcomes (4)
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.
Measured: 30 days post surgery
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.
Measured: 30 days post surgery
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.
Measured: At inclusion and 2 days after inclusion
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).
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start19 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis With PeritonitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854914
- Sponsor's protocol ID
- 21-AOIP-05
- Status last verified
- Aug 2025
- First submitted
- 27 Apr 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Hypnosis on Smartphone for Acute Post-operative Pain
- ClinicalTrials.gov ID
- NCT05854914
- Acronym / sponsor ID
- 21-AOIP-05
- Conditions
- Appendicitis With Peritonitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypnosis video to control postoperative pain. | Experimental | Procedure: Use of hypnosis videos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of hypnosis videosHypnosis on smartphone will be used to manage pain for emergent coelioscopy surgery of patients with acute and complicated appendicitis, with generalized peritonitis | Procedure or surgery | Hypnosis video to control postoperative pain. |
Primary outcome
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.
Time frame: During the first postoperative week
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).
4 secondary outcomes
To study the effect of hypnosis on smartphone on the use of analgesics during hospitalization.
Time frame: 30 days post surgery
To study the effect of hypnosis on smartphone on the average length of hospital stay after the beginning of hypnosis sessions
Time frame: 30 days post surgery
To study the effect of hypnosis on smartphone on the anxiety before and after hypnosis sessions
Time frame: At inclusion and 2 days after inclusion
To study the effect of hypnosis on smartphone on morbidity at postoperative day 30.
Time frame: 30 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
Laparoscopic Versus Open Appendectomy Plus Peritoneal Lavage for Acute Complicated Appendicitis Patients With Diffuse Peritonitis
Acute Complicated Appendicitis With Diffuse Peritonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of hypnosis videos in people with Appendicitis With Peritonitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MASSALOU Damien (04 92 03 33 13 ext. +33, massalou.d@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: During the first postoperative week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.