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The nursing profession is recognized as one of the most demanding in the healthcare sector. Constant exposure to illness, suffering, and death, combined with an increasing workload, leads to fatigue, stress, and especially persistent anxiety. This anxiety affects not only the psychological and physical health of nurses but also the quality of care provided. From an organizational perspective, anxiety promotes absenteeism, demotivation, and turnover, creating a vicious cycle of collective exhaustion.
To relieve their anxiety, an increasing number of healthcare providers are turning to complementary medicine, particularly immersive virtual reality (VR) interventions.
Immersive VR hypnosis has been used for several years as a non-pharmacological approach to anxiety management. It constitutes a relational experience engaging both physiological and psychological mechanisms, allowing the user to improve their experience and reduce or even eliminate anxiety.
Randomized clinical trials conducted in recent years have evaluated the efficacy of immersive VR hypnosis. Some results indicate that it reduces anxiety more significantly than pharmacological treatments in control groups and is at least as effective as other complementary therapies (relaxation, massage, acupuncture, yoga, etc.). However, the strength of these conclusions remains limited due to a substantial risk of methodological bias. Rigorous new studies, with strict control conditions, are required, particularly regarding the efficacy of hypnosis applied to nurses.
Since 2024, the investigators have offered hypnotic VR sessions to nurses at the Clinique du Pont de Chaume to better manage their anxiety. Despite the high satisfaction rate reported in our questionnaires, the investigators now aim to statistically evaluate the efficacy of this intervention. Ultimately, these results could justify a broader investment in this type of equipment, making it available to a larger number of healthcare professionals but only if this complementary intervention demonstrates scientific efficacy.
Research Hypothesis The hypothesis of this study is that hypnotic immersive virtual reality (VR) interventions can reduce nurses' anxiety.
Benefit/Risk Assessment The use of hypnotic immersive VR techniques presents no risk to nurses. This approach is complementary to existing protocols, notably by providing immersive VR headsets during rest periods.
________________________________________ Research Objectives Primary Objective To evaluate the efficacy of hypnotic immersive VR in reducing anxiety among day-shift nurses before and after a coffee break.
Secondary Objective To assess the effect of hypnotic immersive VR on nurses' satisfaction following the coffee break.
Study Design This is a pilot, open-label, randomized controlled trial (RCT), conducted intention-to-treat, single-center, aiming to evaluate the efficacy of hypnotic immersive virtual reality (VR) interventions on day-shift nurses' anxiety after a coffee break.
The protocol is initially limited to day-shift nurses for organizational reasons and to maintain group homogeneity. Night-shift nurses are exposed to different constraints: smaller staff, altered circadian rhythm, limited number of physicians, etc.
The secondary objective of this study is to assess the impact of this intervention on nurses' satisfaction.
________________________________________ Study Endpoints Primary Endpoint The primary endpoint is the change in the Spielberger anxiety score, measured between the beginning and the end of the coffee break.
Secondary Endpoint The secondary endpoint is the nurses' satisfaction, measured using a Likert scale.
________________________________________ Study Timeline Start of recruitment: Upon obtaining all regulatory approvals. Recruitment period: 24 months. Duration of participation per nurse: 1 day (maximum delay between inclusion and data collection).
Total study duration: 27 months. Pre-Inclusion and Inclusion Visits Pre-inclusion visit: Conducted by Dr. PEREIRA DE SOUZA NETO 2 weeks to 1 month before data collection. During this visit, the nurse is informed about the protocol, its objectives, constraints, potential risks (nausea, vomiting), and expected benefits. A copy of the information sheet and consent form is provided for reflection.
Inclusion visit: Conducted by Dr. PEREIRA DE SOUZA on the day of data collection. The nurse provides written informed consent. Both the nurse and investigator sign and date the consent form. Copies are distributed as follows:
One copy is given to the nurse. The original is kept by Dr. PEREIRA DE SOUZA in a secure location inaccessible to third parties, even in case of staff reassignments during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnotic Immersive Virtual Reality Group | Active Comparator |
|
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| Control Group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virtual reality | Other | Since 2024, the investigators have offered hypnotic VR sessions to nurses at the Clinique du Pont de Chaume to better manage their anxiety. Despite the high satisfaction rate reported in our questionnaires, the investigators now aim to statistically evaluate the efficacy of this intervention. Ultimately, these results could justify a broader investment in this type of equipment, making it available to a larger number of healthcare professionals (orderlies, nursing assistants, secretaries, pharmacists, physicians, etc.), but only if this complementary intervention demonstrates scientific efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Spielberger questionnaire measurement | To evaluate the efficacy of hypnotic immersive VR in changing anxiety among day-shift nurses before and after a coffee break. Anxiety will be measured with the Spielberger anxiety score, measured between the beginning and the end of hypnotic immersive VR or between the beginning and the end of the coffee break or | From enrollement to the end of study at 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is the nurses' satisfaction, measured using a Likert scale. | At the end of the session, before returning to work, the nurse completes the Likert scale to evaluate satisfaction. Would you say that the experience with Immersive Virtual Reality had a positive or negative impact? Very positive Somewhat positive Neither positive nor negative Somewhat negative Very negative Any potential adverse effects (nausea, vomiting, etc.) are also recorded. |
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Inclusion Criteria:
Nurses who have received appropriate information, agreed to participate, and signed the informed consent form.
Nurses working day shifts (06:00-18:00) with a coffee break scheduled from 09:00 to 09:15.
Exclusion Criteria:
Nurses who have not provided informed consent or cannot comply with the study protocol.
History of photosensitive epilepsy or seizures. Unstable vestibular disorders or a severe history of motion sickness preventing the use of immersive VR.
Employer refusal if participation cannot be organized outside work obligations (participation must remain voluntary and without professional consequences).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edmundo P PEREIRA DE SOUZA NETO, PhD | Contact | 0770017259 | edmundo.pereira-de-souza@hotmail.fr | |
| Edmundo P Souza Neto, PhD | Contact | 33+770017259 | edmundo.pereira-de-souza@hotmail.fr |
| Name | Affiliation | Role |
|---|---|---|
| Edmundo P PEREIRA DE SOUZA NETO, Phd | Clinique du Pont de Chaume - Montauban | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique du Pont de Chaume - Montauban | Recruiting | Montauban | 82000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30728719 | Background | Williamson A. What is hypnosis and how might it work? Palliat Care. 2019 Jan 31;12:1178224219826581. doi: 10.1177/1178224219826581. eCollection 2019. No abstract available. | |
| 17352896 | Background | Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6. |
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Data collection is performed by Dr. PEREIRA DE SOUZA NETO, and data management by a Data Manager of the Clinical Research and Innovation Department of Clinique du Pont de Chaume.
Any transfer of all or part of the study database is decided by the sponsor and formalized in a written agreement.
At the end of the study
All information required by the protocol must be recorded in the electronic patient record.
Study Monitoring
Logistics and monitoring:
Progress reports:
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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nurses will be randomized into two parallel, open-label groups
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| From enrollement to the end of study at 1 day |
| 23628907 | Background | Tefikow S, Barth J, Maichrowitz S, Beelmann A, Strauss B, Rosendahl J. Efficacy of hypnosis in adults undergoing surgery or medical procedures: a meta-analysis of randomized controlled trials. Clin Psychol Rev. 2013 Jul;33(5):623-36. doi: 10.1016/j.cpr.2013.03.005. Epub 2013 Mar 26. |
| Background | Spielberger CD. State-Trait Anxiety Inventory for adults sampler set manual, instrument and scoring guide. Mind Garden Eds. 1983, 1-75. |
| 18986237 | Background | Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR. Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother. 2008 Nov;8(11):1667-74. doi: 10.1586/14737175.8.11.1667. |
| 29759289 | Background | Pozek JJ, De Ruyter M, Khan TW. Comprehensive Acute Pain Management in the Perioperative Surgical Home. Anesthesiol Clin. 2018 Jun;36(2):295-307. doi: 10.1016/j.anclin.2018.01.007. Epub 2018 Apr 7. |
| 31410922 | Background | Noergaard MW, Hakonsen SJ, Bjerrum M, Pedersen PU. The effectiveness of hypnotic analgesia in the management of procedural pain in minimally invasive procedures: A systematic review and meta-analysis. J Clin Nurs. 2019 Dec;28(23-24):4207-4224. doi: 10.1111/jocn.15025. Epub 2019 Sep 3. |
| 21633506 | Background | Mavros MN, Athanasiou S, Gkegkes ID, Polyzos KA, Peppas G, Falagas ME. Do psychological variables affect early surgical recovery? PLoS One. 2011;6(5):e20306. doi: 10.1371/journal.pone.0020306. Epub 2011 May 25. |
| 23152275 | Background | Madden K, Middleton P, Cyna AM, Matthewson M, Jones L. Hypnosis for pain management during labour and childbirth. Cochrane Database Syst Rev. 2012 Nov 14;11:CD009356. doi: 10.1002/14651858.CD009356.pub2. |
| 26599994 | Background | Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405. |
| 19672167 | Background | Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a. |
| 17558720 | Background | Flory N, Salazar GM, Lang EV. Hypnosis for acute distress management during medical procedures. Int J Clin Exp Hypn. 2007 Jul;55(3):303-17. doi: 10.1080/00207140701338670. |
| 28629342 | Background | Fisch S, Brinkhaus B, Teut M. Hypnosis in patients with perceived stress - a systematic review. BMC Complement Altern Med. 2017 Jun 19;17(1):323. doi: 10.1186/s12906-017-1806-0. |
| 21867380 | Background | Facco E, Casiglia E, Masiero S, Tikhonoff V, Giacomello M, Zanette G. Effects of hypnotic focused analgesia on dental pain threshold. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):454-68. doi: 10.1080/00207144.2011.594749. |
| 25928776 | Background | Elkins GR, Barabasz AF, Council JR, Spiegel D. Advancing Research and Practice: The Revised APA Division 30 Definition of Hypnosis. Am J Clin Hypn. 2015 Apr;57(4):378-85. doi: 10.1080/00029157.2015.1011465. |
| 28598921 | Background | Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169. |
| 29136523 | Background | Berliere M, Roelants F, Watremez C, Docquier MA, Piette N, Lamerant S, Megevand V, Van Maanen A, Piette P, Gerday A, Duhoux FP. The advantages of hypnosis intervention on breast cancer surgery and adjuvant therapy. Breast. 2018 Feb;37:114-118. doi: 10.1016/j.breast.2017.10.017. Epub 2017 Nov 11. |
| 11166472 | Background | Benhaiem JM, Attal N, Chauvin M, Brasseur L, Bouhassira D. Local and remote effects of hypnotic suggestions of analgesia. Pain. 2001 Jan;89(2-3):167-73. doi: 10.1016/s0304-3959(00)00359-6. |
| 20737029 | Background | Askay SW, Patterson DR, Sharar SR. VIRTUAL REALITY HYPNOSIS. Contemp Hypn. 2009 Mar;26(1):40-47. doi: 10.1002/ch.371. |