NCT07293221

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
21mo left

Started Jan 2026

Typical duration for not_applicable anxiety

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Feb 2028

First Submitted

Initial submission to the registry

September 22, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

September 22, 2025

Last Update Submit

December 6, 2025

Conditions

Keywords

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Reduction in the Spielberger questionnaire measurement

    To evaluate the efficacy of hypnotic immersive VR in reducing 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

Secondary Outcomes (1)

  • The secondary endpoint is the nurses' satisfaction, measured using a Likert scale.

    From enrollement to the end of study at 1 day

Study Arms (2)

Hypnotic Immersive Virtual Reality Group

ACTIVE COMPARATOR

* On the day of the study, upon arrival in the coffee break room, nurses complete the Spielberger self-assessment anxiety questionnaire. * The anesthesiologist responsible for the protocol (Dr. PEREIRA DE SOUZA) ensures that the nurse has understood the study protocol and answers any questions. * The nurse then begins the hypnotic immersive VR session in a calm, dedicated room. * At the end of the session, before returning to work, the nurse completes the Spielberger questionnaire again, along with a Likert scale to evaluate satisfaction. Any potential adverse effects (nausea, vomiting, etc.) are also recorded.

Other: virtual reality

Control Group

NO INTERVENTION

* On the day of the study, upon arrival in the coffee break room, nurses complete the Spielberger questionnaire. * The anesthesiologist (Dr. PEREIRA DE SOUZA) ensures understanding of the protocol and answers questions. * The nurse then takes their coffee break normally with their team. * At the end of the coffee break, before returning to work, the nurse completes the Spielberger questionnaire again, along with the Likert scale.

Interventions

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.

Hypnotic Immersive Virtual Reality Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • 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.

    PMID: 30728719BACKGROUND
  • 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.

    PMID: 17352896BACKGROUND
  • 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.

    PMID: 23628907BACKGROUND
  • Spielberger CD. State-Trait Anxiety Inventory for adults sampler set manual, instrument and scoring guide. Mind Garden Eds. 1983, 1-75.

    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.

    PMID: 18986237BACKGROUND
  • 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.

    PMID: 29759289BACKGROUND
  • 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.

    PMID: 31410922BACKGROUND
  • 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.

    PMID: 21633506BACKGROUND
  • 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.

    PMID: 23152275BACKGROUND
  • 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.

    PMID: 26599994BACKGROUND
  • 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.

    PMID: 19672167BACKGROUND
  • 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.

    PMID: 17558720BACKGROUND
  • 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.

    PMID: 28629342BACKGROUND
  • 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.

    PMID: 21867380BACKGROUND
  • 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.

    PMID: 25928776BACKGROUND
  • 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.

    PMID: 28598921BACKGROUND
  • 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.

    PMID: 29136523BACKGROUND
  • 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.

    PMID: 11166472BACKGROUND
  • Askay SW, Patterson DR, Sharar SR. VIRTUAL REALITY HYPNOSIS. Contemp Hypn. 2009 Mar;26(1):40-47. doi: 10.1002/ch.371.

    PMID: 20737029BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Edmundo P PEREIRA DE SOUZA NETO, Phd

    Clinique du Pont de Chaume - Montauban

    PRINCIPAL INVESTIGATOR

Central Study Contacts

guilherme P CACHEFO, PhD

CONTACT

Edmundo P Souza Neto, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: nurses will be randomized into two parallel, open-label groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

December 19, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
At the end of the study
Access Criteria
All information required by the protocol must be recorded in the electronic patient record. Study Monitoring * Logistics and monitoring: * Managed by the Clinical Research Associate (CRA) in collaboration with the principal investigator. * Includes organizing inclusions, participant follow-up, and protocol compliance control. * Progress reports: * The CRA prepares and submits regular progress reports to the sponsor. * Reports include recruitment, adverse events, and collected data.