Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand
Phase: NA
Conditions: Hand Injuries
Sponsor: Centre Hospitalier Departemental Vendee

 
Version N°2 of 14/06/2022   
  
 
 
 
 
 
p1 / 30  
CONFIDENTIAL 
  
HYMN Protocol  
  
- Minimal Risk Minimal Constraint Interventional Research -   
  
  
Registration number: 2019-A03180-57  
  
Ref : CHD 202-19  
  
  
"Interest of hypnosis on pain management during an ultrasound guided 
infiltration of the hand  
  
  
   
Coordinating Investigator :   
   
Adeline TROJET-BOSSARD   
IDE - Rheumatology Department  
CHD Vendée  
Boulevard Stéphane Moreau  
85925 La Roche sur Yon Cedex  
  
  
Methodologist :   
   
Lucie PLANCHE  
Vendée Departmental Hospital Centre  
Clinical Research Unit lucie.planche@chd-vendee.fr  
  
  
 
Promoter :   
   Vendée Departmental Hospital Centre  
Clinical Research Unit  
Boulevard Stéphane MOREAU  
09 
925 LA ROCHE SUR YON Cedex  
85 
 
Tel : 02  51 44 65  72  
Fax : 02  
44 65  
51 
85  
 
 
 
 
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
 
 
 
 
 
 
 p2 / 30  
CONFIDENTIAL 
  
  
  
SIGNATURE PAGE  
  
SIGNATURE OF THE PROMOTER  
  
The sponsor undertakes to carry out this study in accordance with all legislative and 
regulatory provisions that may apply to the research and in accordance with the protocol.  
  
Name and function of the signing 
representative :   
Mr Francis SAINT-HUBERT  
General Director of the CHD  
Vendée  
  
  
Date :  
  
Signature :  
  
  
SIGNATURE OF INVESTIGATOR S  
I have read all the pages of the protocol of the clinical trial for which the CHD Vendée is the 
sponsor. I confirm that it contains all the information necessary for the conduct of the trial. I 
undertake to carry out the trial in accordance with the protocol and the terms and conditions 
defined therein. I undertake to carry out the trial in compliance with :  
  
 the principles of the "Declaration of Helsinki",   
 the international (ICH) and French rules and recommendations of good clinical practice 
(rules of good clinical practice for interventional research involving medicines for human 
use)  
 European and/or national legislation and regulations on clinical trials,  
  
I also undertake that the investigators and other qualified members of my team will have access 
to this protocol and to the documents relating to the conduct of the trial to enable them to work in 
accordance with the provisions of these documents.  
  
Head of Research   
Name :  
  
Adeline TROJET-BOSSARD  
  
  
  
  
Date :  
Signature :  
 
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
 
 
 
 
 
 
 p3 / 30  
CONFIDENTIAL 
LIST OF ABBREVIATIONS  
  
  
  
  
 
 
 
 
ARC  
Clinical Research Associate (monitor)  
GCP  
Good Clinical Practice  
PPC  
Committee for the Protection of Individuals   
CNIL  
Commission Nationale de l'Informatique et des Libertés  
eCRF  
Electronic Case Report Form  
ICH  
International Conference on Harmonization  
MR  
CNIL Reference Methodology  
RIRCM  
Minimal Risk and Minimal Constraint Intervention Research 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
 
 
 
 
 
 
 p4 / 30  
CONFIDENTIAL 
 
TABLE OF CONTENTS  
SIGNATURE PAGE ...................................................................................................................................... 2  
LIST OF ABBREVIATIONS ........................................................................................................................ 3 
TABLE OF CONTENTS .............................................................................................................................. 4  
1. 
RATIONALE FOR THE STUDY ........................................................................................................ 5  
1.1. 
POSITIONING OF THE RESEARCH ....................................................................................................... 5  
1.2. 
BENEFITS AND RISKS FOR RESEARCH PARTICIPANTS ....................................................................... 6  
2. 
OBJECTIVES AND ASSESSMENT CRITERIA .............................................................................. 8  
2.1. 
OBJECTIVE AND PRIMARY ENDPOINT ............................................................................................... 8  
2.2. 
SECONDARY OBJECTIVES AND EVALUATION CRITERIA .................................................................... 8  
3. 
STUDY POPULATION ........................................................................................................................ 9  
3.1. 
DESCRIPTION OF THE POPULATION ................................................................................................... 9  
3.2. 
INCLUSION CRITERIA ........................................................................................................................ 9  
3.3. 
NON-INCLUSION CRITERIA ................................................................................................................ 9  
3.4. 
EXPECTED DURATION OF PARTICIPATION OF INDIVIDUALS AND A DESCRIPTION OF THE TIMING  
AND DURATION OF ALL TRIAL PERIODS, INCLUDING FOLLOW-UP, IF APPLICABLE .................................... 10  
4. 
DESIGN AND STUDY PROCESS .................................................................................................... 11  
4.1. 
GENERAL RESEARCH METHODOLOGY ............................................................................................ 11  
4.2. 
CONDUCT OF THE STUDY AND STUDY SCHEDULE .......................................................................... 11  
4.3. 
SCHEME OF THE STUDY .................................................................................................................. 13  
4.4. 
DESCRIPTION AND JUSTIFICATION OF THE METHOD STUDIED ........................................................ 13  
4.5. 
DESCRIPTION OF THE EVALUATION AND THE DATA COLLECTED ................................................... 14 
4.6. 
IDENTIFICATION OF ALL SOURCE DATA NOT IN THE MEDICAL RECORD ................................  ....... 14  
 4.7.  
RULES FOR STOPPING A PERSON'S PARTICIPATION ......................................................................... 14  
5. 
SAFETY ASSESSMENT .................................................................................................................... 16  
6. 
DATA MANAGEMENT AND STATISTICS ................................................................................... 17  
6.1. 
COLLECTION AND PROCESSING OF STUDY DATA ............................................................................ 17  
6.2. 
STATISTICS ..................................................................................................................................... 18  
7. 
ADMINISTRATIVE AND REGULATORY ASPECTS .................................................................. 
22 
7.1. 
RIGHT OF ACCESS TO SOURCE DATA AND DOCUMENTS .................................................................. 22  
7.2. 
DATA CONFIDENTIALITY ................................................................................................................ 22 
7.3. 
 MONITORING OF THE TRIAL ............................................................................................................ 23  
7.4. 
INSPECTION / AUDIT ....................................................................................................................... 23  
7.5. 
DECLARATION TO THE COMPETENT AUTHORITIES .......................................................................... 23 
7.6. 
AMENDMENTS TO THE PROTOCOL .................................................................................................. 24  
7.7.       COMPUTERISED DATA AND SUBMISSION TO THE CNIL ...............   ................................................ 24  
7.8. PATIENT INFORMATION .................................................................................................................. 24 
7.9. FINANCING AND INSURANCE .......................................................................................................... 25 
7.10. RULES ON PUBLICATION ...............................................................       .............................................. 25  
 7.11.  
ARCHIVING OF SOURCE DATA ..................................................................................................... 26  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
 
 
 
 
 
 
 p5 / 30  
CONFIDENTIAL 
8. 
BIBLIOGRAPHIC REFERENCES .................................................................................................. 27  
9. 
APPENDIX…………………………………………………………………………………………… 28 
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 6/ 30   
CONFIDENTIAL 
1. RATIONALE FOR THE STUDY  
1.1. POSITIONING OF THE RESEARCH  
Echo guided hand infiltration is usually prescribed to relieve chronic pain.  According to the 
International Association for the Study Pain, pain is "an unpleasant sensory and emotional 
experience associated with actual or potential tissue damage, or described in terms suggestive of 
such damage [1]".    
  
Echo guided infiltration is a relatively common procedure and is generally considered to be locally 
painful. This pain induced by the treatment, leads to a strong apprehension among patients who 
have to undergo this procedure.  
  
In order to reduce the stress of the patients, several approaches were put in place, namely: 
explanation of the procedure, setting up a relaxed atmosphere (notably through discussion). All 
these elements constitute a form of hypnosis known as conversational. Nevertheless, according 
to our observations, it remains insufficient for the management of the pain of infiltration.  
  
The practice of hypnosis to improve patient comfort during care has gradually appeared in hospital 
departments. It is used in surgery, particularly for dressings for burn victims, and increasingly in 
medicine [2]. Jean-Marc Benhaiem, in 2003, indicated that "therapeutic hypnosis is a relational 
experience bringing into play physiological and psychological mechanisms allowing the individual 
to better live, to attenuate or to eliminate an acute or chronic painful pathology [3].   The hypnotic 
state would allow to modulate feelings, in particular emotions such as pain or anxiety [4 & 5].  
  
There are several forms of hypnosis, Ericksonian hypnosis lets the subject solve his problem 
without direct intervention dictating the solution. It is only necessary to guide him, to choose the 
ideas, the images... that he likes and that suit him.  
This decreases attention, the relationship to reality, spontaneous mental activity and the 
perception of time, but allows the refocusing of attention towards bodily sensations and mental 
contents proposed by the induction, as well as concentration and adherence to the imagery.  
Erickson said: "go and find your own ways to change".  
Ericksonian hypnosis is essentially therapeutic, it is not spectacular. This method can be 
integrated into the treatment process without significantly increasing the time of the procedure.  
  
Among the different conversational hypnosis techniques that exist, there is the magic pen where 
the patient is made to choose a pencil, the liquid is described, the colour, the smell... and the 
pencil is put on the hand, the liquid is allowed to imagine that it is put in the hand and it is spread 
"like sunshine", the liquid is made to feel by rubbing the hand, which creates a protection.  
  
There is another technique which takes the patient to the place they want with a formal, 
nonconversational induction, often questioning, but lasting more than thirty minutes.  
  
Each way brings the patient into a similar altered state of consciousness. Everything is improvised, 
it depends on the individual.  
  
Within the framework of the Hymn project, the "magic glove" technique was chosen because it 
seems to us to be the simplest to carry out with the patient and is consistent with the hand 
infiltration technique.  This technique consists of creating an imaginary glove, invented by the 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 7/ 30   
CONFIDENTIAL 
patient himself, around his hand which will "anaesthetise" the pain. The patient's hand is cataleptic 
or levitated, and is then connected to what is pleasant, "luminous".  
  
  
We wish to evaluate here the interest of hypnosis on the pain felt by the patient during the 
realization of an echo-guided infiltration of the hand, one of the most painful extremities during 
infiltrations.  
  
1.2. BENEFITS AND RISKS FOR RESEARCH PARTICIPANTS  
 
1.2.1.  
Benefits  
 
1.2.1.1.  
Individual benefit  
The expected benefit of a hypnosis session prior to an ultrasound-guided hand infiltration is a 
reduction in the sensation of pain at the time of the infiltration.  
  
This benefit will be objectively assessed by means of a pain assessment directly by the person 
using a pain scale (VAS)  
 
1.2.1.2.  
Collective benefit  
The use of hypnosis in the performance of painful treatments such as ultrasound-guided hand 
infiltration could optimise patient care.  
This could also reduce the time of the procedure as patients will be more relaxed and the 
rheumatologist will be able to perform the procedure more accurately.  
   
 
1.2.2.  
Risks  
No excess risk is expected as a result of participation in the study.   
  
 
1.2.2.1.  
Individual risk  
 Related to the hypnosis procedure: no risk has been demonstrated for the practice of 
hypnosis [2]. No individual risk is expected for this study  
  
 
1.2.2.2.  
Individual constraints  
The constraints related to filling in the questionnaires are considered minimal. In the experimental 
group "Infiltration under ultrasound + Hypnosis", the consultation will be extended by about ten 
minutes compared to usual practice.  
   

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 8/ 30   
CONFIDENTIAL 
 
1.2.2.3.  
Collective risk  
No collective risk is expected for this study. There are no changes in management outside of 
randomisation.   
  
 
1.2.3.  
Benefit/risk balance  
The person in charge of the research qualifies it as interventional research with minimal risks 
and constraints, because the hand infiltration technique and the drugs are used in common 
practice. It is not expected that there will be any excess risk in relation to these practices as a 
result of participation in the protocol.   
  
The research does not focus on innovative or obsolete techniques or strategies.  
  
The overall management of the patient will be the same as usual.   
  
Consequently, the particular modalities of implementation in the research represent negligible 
constraints for the person who lends himself to the research. (Article R 1121-3 of the Public Health 
Code (CSP), decree n° 2006-477 of 26 April 2006)  
  
The person in charge of the research will therefore, before any implementation of the research, 
submit the study protocol to a Committee for the Protection of Individuals in accordance with article 
L 1121-1 of the Public Health Code (CSP) as they result from laws n° 2004-806 of 9 August 2004 
and n° 2006-450 of 18 April 2006 relating to public health policy, for a favourable opinion and 
confirmation of the qualification of the research.  
 
  
2. OBJECTIVES AND JUDGING CRITERIA  
2.1. OBJECTIVE AND PRIMARY ENDPOINT  
 
2.1.1.  
Main objective  
The main objective is to show that the practice of hypnosis makes it possible to reduce the pain 
felt by the patient during an ultrasound-guided infiltration procedure on the hand.  
  
 
2.1.2.  
Primary endpoint  
VAS pain at rest 5 minutes after the ultrasound-guided infiltration of the hand  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 9/ 30   
CONFIDENTIAL 
2.2. OBJECTIVES AND SECONDARY ENDPOINTS  
 
2.2.1.  
Secondary objective(s)  
Assessment of patient anxiety 5 minutes after the procedure is performed  
 
2.2.2.  
Secondary endpoint(s)  
Spielberger Anxiety-Status Scale (STAI form Y-A) score experienced 5 minutes after infiltration   
 
 
3. STUDY POPULATION  
3.1. DESCRIPTION OF THE POPULATION  
 Number of patients to be randomised: 80 patients randomised (see § justification of the 
number of subjects).  
   
This study is aimed at adult patients treated in the rheumatology department of the CHD Vendée 
for the first time for an ultrasound guided infiltration of the hand.   
  
Recruitment will be carried out prospectively on arrival in the rheumatology department  
   
4 to 6 new patients per month are treated by the CHD Vendée for a first hand infiltration under 
ultrasound.   
  
The study plans to include 92 patients. However, the inclusion period will end when 80 patients 
are randomised.   
   
3.2. INCLUSION CRITERIA  
- 
Patient with an indication for a first hand infiltration under ultrasound  
- 
Patient of legal age  
- 
Patient with the ability to understand the protocol and who has given informed consent  
- 
Patient with social security coverage  
3.3. NON-INCLUSION CRITERIA  
- 
Patient with a preventive pain patch on the area to be infiltrated  
- 
Contraindication to infiltration (unbalanced diabetes, unbalanced hypertension, ongoing 
infections)  
- 
Hearing impaired patient   

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 10/ 30   
CONFIDENTIAL 
- 
Patient under guardianship/guardianship  
- 
Minor  
- 
Pregnant woman  
- 
Patient participating in another interventional research protocol  
- 
Patient unable to follow the protocol, as judged by the investigator.  
 
 
3.4. EXPECTED DURATION OF PARTICIPATION OF INDIVIDUALS AND 
A DESCRIPTION OF THE TIMING AND DURATION OF ALL TRIAL 
PERIODS  
Inclusion period: 26 months  
Duration of patient participation: 2 hours  
Duration of the study: 26 months  
  
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 11/ 30   
CONFIDENTIAL 
4. DESIGN AND STUDY PROCESS  
4.1. GENERAL RESEARCH METHODOLOGY  
  
The research has the following characteristics:   
  
-  Type of research: Minimal Risk Minimal Constraint Interventional Research (MRIC) - 
 
Single-centre, controlled, randomised, open-label, superiority study.   
  
4.2. CONDUCT OF THE STUDY AND TIMETABLE OF THE STUDY  
  
1. Inclusion and Randomisation (D0)  
  
eIn order to ensure the feasibility of the study, patients scheduled for ultrasound-guided hand 
infiltration will be scheduled when two nurses, one of whom is trained in hypnosis, are present on 
the ward.  
  
The inclusion consultation will check the inclusion and non-inclusion criteria. A presentation of the 
study will be made by one of the two nurses. Written information will be given to the eligible patient. 
The patient's oral, informed consent will then be collected.  
  
Randomisation will be carried out during this consultation. Depending on the randomisation arm 
the patient will receive either :  
- 
A single ultrasound-guided infiltration of the hand (standard arm)  
- 
A single ultrasound-guided infiltration of the hand under hypnosis (experimental arm).  
  
In this study, where the standard of care is "infiltration only", a placebo group is not planned. The 
aim of our study is to evaluate the contribution of hypnosis as a global approach to patient 
management.   
  
Echo guided infiltration technique - Standard arm:  
The patient will be installed in the usual way by the non-hypnosis trained nurse.  
The rheumatologist will carry out the localisations under ultrasound. The nurse will then disinfect 
the patient's hand in 3 steps with an iodinated skin antiseptic. The infiltration will be carried out in 
a standardised way by a rheumatologist of the department.  
  
  
Hypnosis-guided echo infiltration technique - Experimental arm:  
Hypnosis will be started after the result of the randomisation, the patient will be taken care of by 
the nurse trained in hypnosis (see § 4.4 description of the method used).   

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 12/ 30   
CONFIDENTIAL 
When the patient is ready, just after the hypnosis session, the nurse will disinfect the patient's 
hand in 3 steps with an iodinated skin antiseptic and the rheumatologist will perform the infiltration 
in a standardised way.   
  
 In both groups, the Spielberger Anxiety-Trait Scale (STAI form Y-B) will be collected before the 
intervention and before hypnosis (experimental arm). This score will be used to characterise and 
describe patients' anxiety before the intervention.   
  
In both groups, the Spielberger Anxiety-Status Scale (STAI form Y-A) will be performed 5 minutes 
after the infiltration procedure.  
  
The pain VAS will be collected before the hypnosis intervention in order to characterise the pain 
related to the pathology.  
  
The pain VAS will then be collected 5 minutes after the infiltration procedure in order to 
characterise the pain linked to the infiltration procedure.  
  
The use of analgesic treatments by the patient before the ultrasound guided infiltration will be 
collected.  
  
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 13/ 30   
CONFIDENTIAL 
 
  
TIMETABLE OF THE STUDY   
  
Actions  
J0  
(Inclusion visit)  
5 minutes after the action 
Patient information  
X  
  
Informed oral consent   
X  
  
Randomisation   
X  
  
Background  
X  
  
Clinical examination  
X  
  
Hypnosis  
X  
  
Medical procedures: ultrasound-guided infiltration  
X  
  
VAS for pathology-related pain  
X  
  
EVA pain of the gesture  
  
X  
Anxiety-Trait Scale  
X  
  
Anxiety-Status Scale  
  
X  
Analgesic treatments  
X  
  
 
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 14/ 30   
CONFIDENTIAL 
4.3. SCHEME OF THE STUDY  
  
  
 
   
4.4. DESCRIPTION AND JUSTIFICATION OF THE METHOD STUDIED  
  
The duration of the hypnosis session will be measured.  
The hypnosis session consists of building a "magic glove" with the patient on the hand on which 
the infiltration will be performed.  
The nurse sets up the patient and the rheumatologist uses the ultrasound machine to locate the 
hand.   
The nurse, trained in hypnosis, starts the timer, takes the patient's hand in her hand and begins 
the hypnosis session. The principle is to get the patient to imagine a glove that they will create to 
put on their painful hand.   
The nurse lets the patient choose the colour, material and asks how far the glove fits on the arm.   
The nurse guides the patient to put the glove on each finger by touching the hand.   
By suggestion, the nurse forms an anaesthetic area on the hand according to the patient's choice. 
If the "protection" is not sufficient, the nurse adds a "strip" or "resin" to increase the anaesthetic.  
  
A phenomenon of catalepsy or levitation of the hand is generated in the patient.  
  
The "magic glove" technique is suitable for hand infiltration because a glove can be slipped onto 
a hand.  
  
When the patient is ready, the nurse stops the timer and disinfects the patient's hand in 3 steps 
and the rheumatologist carries out the infiltration in a standardised manner.   
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Indication  
Randomisation  
Consent and inclusion  
Inclusion criteria met  
standard arm :   
Infiltration under ultrasound  
 
experimental arm :  
Infiltration under ultrasound  
+ Hypnosis  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 15/ 30   
CONFIDENTIAL 
4.5. DESCRIPTION  
OF  THE  EVALUATION  
AND  THE  DATA 
COLLECTED  
- 
The Visual Analogue Scale (VAS) of pain is used to assess the progression of pain (Scott 
& Huskisson, 1976). It is rated from 0 to 10 on a ruler, and the patient must move the 
cursor on the side without graduation. The nurse records the intensity of the pain felt on 
the graduated side.  
  
- 
The Spielberger Anxiety-State Scale is a way of finding out what the patient is feeling "right 
now, just at this moment". It consists of 20 items (10 items reversed). The scale assesses 
the intensity of what the patient is feeling. Each item is rated from 1 to 4, with 1 indicating 
the lowest degree of anxiety and 4 the highest.   
It is a questionnaire that takes an average of 5-10 minutes to complete. The sensitivity of 
the items to changes in anxiety in different anxiety-provoking situations has been 
demonstrated [6].  
  
- 
The Spielberger Anxiety-Trait Scale captures what the patient "usually" feels. It consists of 
20 items (9 items reversed). The scale assesses the frequency of what the patient feels. 
Each item is rated from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the 
highest. This questionnaire takes an average of 5 to 10 minutes to complete.  
  
Both questionnaires have been validated in French [6].  
4.6. IDENTIFICATION OF ALL SOURCE DATA NOT IN THE MEDICAL 
RECORD  
- 
EVA pain before the infiltration procedure and before hypnosis  
- 
VAS pain 5 minutes after the infiltration procedure  
- 
Anxiety-Treatment scale before the infiltration procedure and before hypnosis  
- 
Anxiety-Status scale 5 minutes after the infiltration procedure   
4.7. RULES FOR STOPPING A PERSON'S PARTICIPATION  
4.7.1. Criteria for premature termination of a person's participation 
in research  
A person's participation may be terminated prematurely for the following reasons:  
- Withdrawal of consent by the patient  
Subjects will be able to withdraw their consent and ask to leave the study at any time and for any 
reason.  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 16/ 30   
CONFIDENTIAL 
 
4.7.2.  
Data collection schedule  
  
In case of withdrawal of consent by the patient, and without prejudice to the patient's right, the 
data already collected will be analysed unless the patient objects.   
  
No other examinations specifically foreseen by the protocol will be carried out and no data will be 
used according to the patient's wishes after withdrawal of consent.   
  
The discharge of a patient from the study will not change the usual management of the patient's 
condition.   
4.7.3. Discontinuation of part or all of the research by decision of 
the sponsor (excluding biostatistical considerations)  
Part or all of the study may be stopped permanently or temporarily by decision of the ANSM, the 
CPP or the Study Sponsor.   
   
In all cases :   
- 
A written confirmation will be sent to the coordinating investigator of the study 
(specifying the reasons for premature termination).  
- 
All patients in the study will be informed.    
 
    
5. SAFETY ASSESSMENT  
In the context of this Minimal Risk and Minimal Constraint Interventional Research (RIPH Category 
2), the adverse event(s) (serious or not) do not have to be notified to the sponsor. Notification 
must be made within the framework of the vigilance set up in the context of care for the product 
or practice which is the subject of the research (pharmacovigilance for a drug, materiovigilance 
for a medical device, etc.) according to the regulations in force.  
  
  
Only "new facts" and malfunctions that may interfere with the research must be transmitted to the 
sponsor without delay after becoming aware of them so that corrective measures can be put in 
place. For these malfunctions, the investigator can use the reporting form to the regulated system, 
made anonymous (patient inclusion number only).  
  
A new fact is any new data that may lead to a reassessment of the benefit/risk ratio of the research 
or the product under investigation, to changes in the use of the product, in the conduct of the 
research, or in the documentation of the research, or to the suspension or discontinuation or 
modification of the research protocol or similar research.  
  
The promoter shall inform the competent authority and the Committee for the Protection of 
Individuals without delay of the new facts and, where appropriate, of the measures taken, as from 
the day on which he becomes aware of them.  
  
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 17/ 30   
CONFIDENTIAL 
6. DATA MANAGEMENT AND STATISTICS  
6.1. COLLECTION AND PROCESSING OF STUDY DATA  
 
6.1.1.  
Data collection  
One case report form (CRF/ eCRF) will be created per patient. All information required by the 
protocol should be provided in the CRF/eCRF. It should include the data needed to confirm 
compliance with the protocol and all data needed for statistical analysis; it should identify major 
deviations from the protocol.  
  
The person(s) responsible for filling in the CRFs/eCRFs (investigator, CRA...) should be defined 
and is/are identified in the Centre's Delegation of Duties Form (kept in the investigator's folder).  
  
 
6.1.2.  
Data coding  
By signing the protocol, the principal investigator and all co-investigators agree to keep 
confidential the identity of the patients who participated in the study.   
  
The transmission of a person's data for research purposes will therefore only be possible if a 
coding system is applied; the presentation of the research results must exclude any direct or 
indirect identification.   
  
The identification of patients will be done according to the order of inclusion of patients by a 
number automatically assigned by the Clinsight software (eCRF) then completed by the initials 
of the patients (1st letter of the first name + 1st letter of the last name).   
  
This code will be the only information that will appear on the eCRF notebook and will allow the 
eCRF to be linked to the patient afterwards.   
The investigator is also required to code the patient data on any documents he/she may have in 
his/her possession (reports of imaging or biological examinations, etc.) which are attached to the 
eCRF.   
  
A mapping table will be set up in the participating centre. This table will be kept in a secure place 
by the principal investigator of the centre and will contain the patient code and his or her personal 
data in order to be able to go back to the patient file in case of missing or erroneous data. No 
clinical data will be collected in these correspondence tables.  
  
   
 
6.1.3.  
Data processing  
The collection of clinical data will be based on the implementation of a database and the creation 
of data entry masks similar to the observation book in accordance with the protocol and 
regulations currently in force.  
  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 18/ 30   
CONFIDENTIAL 
6.2. STATISTICS  
Software  
The analyses will be carried out using R software version 3.5.1  
  
6.2.1. Description of the planned statistical methods, including the 
timing of planned interim analyses  
  
All variables will be described globally and by group. The description will include the numbers and 
percentages of modalities for qualitative variables and the minimum, maximum, mean, standard 
deviation and median for quantitative variables.  
  
VAS pain  
  
The average pain felt during the procedure (collected 5 minutes after the procedure) will be 
estimated with a 95% confidence interval in the two groups. It will be compared using a Student's 
t test.  
  
Anxiety   
  
Anxiety after the procedure will be collected using the State-Anxiety questionnaire (STAI form YA). 
The total score of the questionnaire will be calculated in both groups. The mean will be presented 
with a 95% confidence interval and compared using a Student's t test.  
  
 
6.2.2.  
Statistical justification of the number of inclusions  
Currently, there is no data in the literature on the pain experience during ultrasound-guided 
infiltration of the hand. It has been shown that a decrease of 1.1 on the VAS is clinically significant 
in patients with rheumatoid arthritis (Wolfe et al. 2007).  
We hypothesise that the hypnosis session may reduce the pain experienced during the procedure 
by 2 points. According to data from a study carried out in the department on patients for whom an 
infiltration of the thumb is indicated, we have retained a standard deviation of 3 for the pain felt 
during the infiltration procedure. Based on these assumptions and setting an alpha risk of 5% and 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 19/ 30   
CONFIDENTIAL 
a power of 80%, a total of 74 patients should be randomised. In order to guarantee the power of 
the study, an additional 5% of patients will be randomised, i.e. 80 patients in total.  
 
6.2.3.  
Expected level of statistical significance  
The alpha risk is set at 5%.   
 
6.2.4.  
Statistical criteria for stopping the research  
NA   
6.2.5.  
Method of accounting for missing, unused or invalid 
data  
All missing data and the reason for it will be described in each group.  
  
For the analysis of the primary outcome, a multiple imputation method will be applied.  
 
6.2.6.  
Managing changes to the original strategy analysis 
plan  
NA  
 
6.2.7.  
Selection of persons to be included in the analyses  
The main analysis will be performed on the Intent-to-Treat (ITT) population, i.e. on all randomised 
patients.  
  
A complementary analysis will be performed on the Per Protocol (PP) population including the 
randomised patients for whom no major protocol deviations have been identified.  
A data review meeting will be held to review and define the major criterion or not for each of the 
deviations.  
 
6.2.8.  
Randomisation  
Randomisation will not be stratified.  
  
It will be carried out in a 1:1 ratio and will be done in blocks.  
  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 20/ 30   
CONFIDENTIAL 
Randomisation will be carried out in Ennov Clinical by connecting to the website: https://www.dirc-
hugo-online.org/csonline/. The connection will be made through a login, a password and a study 
number, delivered by the data manager of the Research Unit of the La Roche sur Yon Hospital. 
The following information must be filled in:  
  
-First initial of the name,  
  
-First initial of the first name,  
  
-Month and Year of birth,  
  
Compliance with inclusion and non-inclusion criteria (yes/no),  
  
  
Randomisation will be carried out by the investigator after confirmation of the possibility of 
inclusion in the study. The inclusion number will be assigned automatically during randomisation. 
A confirmation email will be sent to the person who performed the randomisation and to all persons 
involved.  
  
The randomisation list will be carried out by the statistician of the Research Unit of the CHD of  
La Roche sur Yon. An explanatory guide to randomisation will be available online in Ennov  
Clinical.  
  
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 21/ 30   
CONFIDENTIAL 
7. ADMINISTRATIVE AND REGULATORY ASPECTS  
7.1. RIGHT OF ACCESS TO SOURCE DATA AND DOCUMENTS  
In accordance with GCP :  
- 
The sponsor is responsible for obtaining the agreement of all parties involved in the 
research to ensure direct access to all research sites, source data and reports for quality 
control and audit purposes by the sponsor,  
- 
The investigators will make available to the persons in charge of monitoring, quality 
control or auditing the research, the documents and individual data strictly necessary for 
this control, in accordance with the legislative and regulatory provisions in force (articles 
L.1121-3 and R.5121-13 of the Public Health Code).  
  
Source documents, defined as any original document or object that can be used to prove the 
existence or accuracy of a data or fact recorded during the clinical study, should be kept for 15 
years by the investigator or by the hospital in the case of a hospital medical record.  
7.2. DATA PRIVACY  
Persons with direct access shall take all necessary precautions to ensure the confidentiality of 
information relating to the persons who have access, in particular as regards their identity and the 
results obtained.  
These persons, as well as the investigators themselves, are subject to professional secrecy 
(according to the conditions defined by articles 226-13 and 226-14 of the penal code).  
During or after the research, the data collected on the subjects and transmitted by the participants 
will be made anonymous.  
Under no circumstances should the names of the persons concerned or their addresses appear 
in clear text.   
Only the first letter of the subject's name and the first letter of the subject's first name will be 
recorded, along with a study-specific code number indicating the order of inclusion of the subjects.   
 
 
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 22/ 30   
CONFIDENTIAL 
7.3. MONITORING OF THE TRIAL  
Monitoring will be carried out by the Promotion Department of the Research Directorate. A 
Clinical Research Associate (CRA) will regularly visit the investigator site to check the quality of 
the data reported in the observation books.  
  
The monitoring plan is defined in consultation between the research team and the responsible 
institution according to the objectives of the study.  
  
The protocol has been classified according to the estimated level of risk to the patient undergoing 
the research. It will be monitored as follows:   
Risk A: low or negligible foreseeable risk  
  
On-site monitoring visits will be organised after an appointment with the investigator. CRAs should 
be given access to each site:  
- the data collection books of the patients included,  
- patients' medical and nursing records, - the investigator's binder.  
7.4. INSPECTION / AUDIT  
In the context of this study, an inspection or audit may take place. The sponsor and/or the 
participating centre must be able to give access to the data to the inspectors or auditors.  
7.5. DECLARATION TO THE COMPETENT AUTHORITIES  
The sponsor undertakes to submit the study project for prior authorisation by a Personal Protection 
Committee (CPP). The information communicated concerns, on the one hand, the modalities and 
nature of the research and, on the other hand, the guarantees provided for the patients 
participating in this trial.  
  
This protocol will also be reported to the ANSM.  
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 23/ 30   
CONFIDENTIAL 
7.6. AMENDMENTS TO THE PROTOCOL  
Requests for substantial modifications will be sent by the sponsor to the CPP concerned for its 
opinion and to the ANSM for information in accordance with the law in force and its implementing 
decrees.  
  
An updated dated version of the amended protocol will be required.  
The patient information and consent forms will need to be amended if necessary.  
  
7.7. COMPUTERISED DATA AND SUBMISSION TO THE CNIL  
The data collected in this study are for scientific research purposes, for the public good.   
  
This study falls within the scope of the "Reference Methodology" MR-001 registered, for the CHD 
Vendée, under n°2060482 v 0 for the following reasons   
- Collection of health data for research purposes   
- Obtaining the opinion of a CPP to start the research   
- Use of anonymised data   
- Individual information of data subjects   
- Access to data only by professionals (health and sponsor) involved in the study.   
  
The fact that this study falls within the scope of MR001 and the reasons for this will be notified in 
the sponsor's treatment register.  
7.8. PATIENT INFORMATION  
 
7.8.1.  
Informed consent oral   
The investigator undertakes to obtain the free, informed and express consent of the patient, 
obtained orally, after having given him/her information on the protocol (information note and 
consent form in the appendix). The information will be given to the patient before the infiltration 
planned as part of his or her treatment. He will be given a copy of the information note and an oral 
consent form. The person can only be included in the study after having read the information note 
and given oral consent after having had, if necessary, time to reflect. The reflection time will be a 
few minutes.   
  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 24/ 30   
CONFIDENTIAL 
The patient's information and consent to participate in the research should be recorded in the 
patient's medical record.  
  
A copy of the information note and the consent form signed by the investigator will be given to the 
patient, the investigator will keep the original.  A copy will be placed at the end of the study in a 
sealed tamper-proof envelope containing all the consent forms, which will be archived by the 
sponsor.  
   
7.9. FINANCING AND INSURANCE  
The promoter finances the study and takes out an insurance policy to cover the financial 
consequences of its civil liability, in accordance with the regulations.  
7.10. RULES ON PUBLICATION  
The study will be registered on an open access website (Clinical trial) before the first patient is 
included in the study.  
  
Scientific papers and reports related to this study will be produced under the responsibility of the 
study coordinator with the agreement of the principal investigators of the participating centres.   
  
The coordinating investigator establishes the list of authors.   
A professional attached to the CHD Vendée at the time of publication will necessarily appear in 
the ranks of the first or last author.   
  
The rules for publication will follow international recommendations (N Engl J Med, 1997; 336:309-
315).   
  
A copy of the publication will be given to the CHD Vendée promoter of the study, which will 
necessarily be cited.  
  

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 25/ 30   
CONFIDENTIAL 
7.11. ARCHIVING OF SOURCE DATA  
The investigator should keep all information about the study for at least 15 years after the end of 
the study.  
At the end of the study, the investigator will receive a copy of each patient's data from his centre 
sent by the sponsor.   
  
No removal or destruction can be carried out without the agreement of the Promoter. At the end 
of the 15 years, the Promoter will be consulted for destruction. All data, documents and reports 
may be subject to audit or inspection.  
  
 

HYMN" protocol - CHD 202-19   
  
Version N°2 of 14/06/2022   
  
 p. 26/ 30   
CONFIDENTIAL 
8. BIBLIOGRAPHIC REFERENCES  
  
[1] Merskey H. & Bogduk N. (1994). 2nd editon Classification of chronic pain. Seattle: IASP Press  
  
[2] https://www.inserm.fr/sites/default/files/2017- 
11/Inserm_RapportThematique_EvaluationEfficaciteHypnose_2015.pdf  
  
[3] Benhaiem J.M. (March 1999). The choice of hypnosis for pain relief. La Douleur, des 
recommandations pratiques 7, 1-5.  
  
[4] Maquet P, Faymonville M.E, Degueldre C, Delfiore G, Franck G, Luxen A, Lamy M. (1999). Functional 
neuroanatomy ofhypnotic state. Biological Psychiatry, 45(3), 327-33  
  
  
[5] Rainville P, Hofbauer RK, Bushnell MC. (2002). Hypnosis modulates activity in brainstructures 
involved in the regulation of consciousness. Journal of Cognitive Neuroscience, 14(6), 887-901.  
  
[6] Bouchard, S., Gauthier, J., Thibodeau, C., & Ivers, H. (1999). The Situational Anxiety and Anxiety Trait 
Inventory Form "Y" in a population of college students, Canadian Journal of Psycho-Education, 28(2), 
279-288.  
 
 
 
 

Protocole « HYMN » - CHD 202-19 
 
Version N°2 of 14/06/2022   
  
 p. 27/ 30   
CONFIDENTIAL 
 
 
9. Appendix 
Echelle d’Anxiété-Trait de Spielberger 
 
Questionnaire d’anxiété générale de Spielberger  
 
 
Instruction : 
Ci-après figurent un certain nombre de déclarations que les gens utilisent souvent 
pour se décrire. Lisez chacun des énoncés et cochez dans le case appropriée de 
droite ce qui convient le mieux à la façon dont vous vous sentez en général. Il 
n'existe ni bonnes ni mauvaises réponses. Ne passez pas trop de temps sur 
chacun des points, mais donnez la réponse qui semble décrire le mieux ce que 
vous ressentez généralement. Répondez à toutes les questions et ne cochez 
qu'une case pour chacune d'entre elles. 
 
 
 
Activités 
Etat 
1. 
Je me sens dans de 
bonnes dispositions 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
2. 
Je me sens nerveux et 
agité 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
3. 
Je suis content de moi 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
4. 
Je voudrais être aussi 
heureux que les autres 
semblent l'être 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
5. 
Je me sens un raté 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
6. 
Je me sens paisible 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
7. 
Je suis calme, détendu 
et de sang froid 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
8. 
J'ai l'impression que les 
difficultés se multiplient 
à un point tel que je ne 
peux les surmonter 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
9. 
Je m'inquiète trop à 
propos de choses qui 
n'en valent pas la peine 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 

Protocole « HYMN » - CHD 202-19 
 
Version N°2 of 14/06/2022   
  
 p. 28/ 30   
CONFIDENTIAL 
 
10. 
Je suis heureux 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
11. 
J'ai des pensées qui me 
tourmentent 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
12. 
Je 
manque 
de 
confiance en moi 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
13. 
je suis sûr de moi 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
14. 
Je prends facilement 
des décisions 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
15. 
Je ne me sens pas à la 
hauteur 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ Souvent 
☐ 
Presque 
toujours 
16. 
Je suis content 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ 
Souvent 
☐
 
Presque 
toujours 
17. 
Des 
pensées 
sans 
importance me trottent 
dans la tête et me 
tracassent 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ 
Souvent 
☐
 
Presque 
toujours 
18. 
Je 
ressens 
les 
contretemps 
si 
fortement que je ne 
peux les chasser de 
mon esprit 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ 
Souvent 
☐
 
Presque 
toujours 
19. 
Je suis quelqu'un de 
calme 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ 
Souvent 
☐
 
Presque 
toujours 
20. 
Je suis tendu ou agité 
dès que je réfléchis à 
mes 
soucis 
et 
problèmes actuels 
☐ 
Presque 
jamais 
☐ 
Parfois 
☐ 
Souvent 
☐
 
Presque 
toujours 
 
 
 
 
 

Protocole « HYMN » - CHD 202-19 
 
Version N°2 of 14/06/2022   
  
 p. 29/ 30   
CONFIDENTIAL 
 
Echelle d’Anxiété-Etat de Spielberger 
 
Questionnaire d’anxiété Etat de Spielberger  
 
Date de réalisation: I__I__I/I__I__I/I__I__I__I__I 
 
Instruction : 
 
Ci-après figurent un certain nombre de déclaration que les gens utilisent souvent 
pour se décrire. Lisez chacun des énoncés et cochez dans le case appropriée de 
droite ce qui convient le mieux à la façon dont vous vous sentez maintenant avant 
cette compétition ; Il n'existe ni bonnes ni mauvaises réponses. Ne passez pas 
trop de temps sur chacun des points, mais donnez la réponse qui semble décrire 
le mieux ce que vous ressentez dans cette situation. Répondez à toutes les 
questions et ne cochez qu'une case pour chacune d'entre elles.  
 
A présent, répondez à la liste suivante par : Pas du tout, un peu, modérément, 
beaucoup 
 
1. 
Je me sens calmer 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
2. 
Je me sens sûr de moi 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
3. 
Je suis tendu 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
4. 
Je me sens contraint 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
5. 
Je me sens à mon aise 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
6. 
Je me sens bouleversé 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
7. 
Je m'inquiète à l'idée de 
malheurs possibles 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
8. 
Je me sens satisfait 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
9. 
J’ai peur 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
10. 
Je me sens bien 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
11. 
J'ai confiance en moi 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
12. 
Je me sens nerveux 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
13. 
Je suis agité 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 

Protocole « HYMN » - CHD 202-19 
 
Version N°2 of 14/06/2022   
  
 p. 30/ 30   
CONFIDENTIAL 
 
14. 
Je me sens indécis 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
15. 
Je suis détendu 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
16. 
Je suis content 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
17. 
Je suis inquiet 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
18. 
Je me sens troublé 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
19. 
Je me sens stable 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup 
20. 
Je me sens dans de 
bonnes dispositions 
☐ Pas 
du tout 
☐ Un 
peu 
☐ 
Modérément 
☐ 
Beaucoup