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HypnosisHYPNOVRNEONCT06786962

Virtual Reality Hypnosis and Nurses' Stress

A study testing Virtual reality Hypnosis in people with Hypnosis and Virtual Reality Therapy, run by CARESP: Cellule d'animation régionale en soins palliatifs at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The practice of nursing is based on helping relationships and empathy. The work is physically, mentally and emotionally demanding. This requires the mobilization of personal resources (lifestyle, coping strategies) and work resources (managerial, medical support, recognition) to cope with stress. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypnosis, Virtual Reality Therapy, Stress
What is being tested?
Virtual reality Hypnosis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteFrance
Study dates
4 Nov 2024to 12 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Nurse
  • Regularly work in a neonatal intensive care unit
  • Be of legal age and not opposed to participating in research
  • Fluency in French

Who cannot join

  • Age < 18
  • Refusal to participate
  • Current anticonvulsant or psychotropic treatment

Trial locations and contacts

1 site in 1 country.

France1 site
  • RENNES

    Rennes, Brittany Region, 35000

Other trials in France

About this study

Official title: Effects of a Virtual Reality Hypnosis Intervention on Reducing Stress and Compassion Fatigue in Neonatal Intensive Care Nurses

The practice of nursing is based on helping relationships and empathy. The work is physically, mentally and emotionally demanding. This requires the mobilization of personal resources (lifestyle, coping strategies) and work resources (managerial, medical support, recognition) to cope with stress. When these resources are present, nurses can activate a resilience process through coping strategies. However, stress levels and emotional impact are such that they can lead to states of suffering and trauma such as compassion fatigue (CF). The prevalence of CF is high in the nursing profession and particularly among neonatal intensive care (NICU) nurses.

Several levels of intervention exist to prevent CF in services: organizational, inter-individual and individual. At the individual level, certain interventions such as meditation have been studied, showing positive effects with the highest levels of evidence.

On the other hand, interventions such as hypnosis have not yet been studied in this context. There is, however, an interest in studying hypnosis as a non-pharmacological intervention to reduce stress and improve emotional regulation. Indeed, the hypnotic process (promoting attentional and cognitive rest, redirecting attentional focus, reducing mental effort) is a resource activator. In order to combine individual and organizational support, the intervention must be offered in the workplace and during working hours, given the difficulty nurses have in extracting themselves from the service, the restricted break time and the acceptability of the virtual reality system. In a context where break time is short and precious, it is necessary to use a tool that adapts to these constraints. Virtual reality with the HypnoVR® tool meets these needs. This device acts as a restorative environment. It has already proven its effectiveness in the care of painful and stressed patients in critical situations. It has not yet been studied in the context of work-related stress in healthcare professionals, such as neonatal intensive care nurses. The protocol takes into account the results of studies reporting the effects associated with the use of virtual reality (VR).

Being tested
Virtual reality Hypnosis, Control arm (SEQ):
Keywords
Hypnosis, Virtual reality, Stress, Compassion fatigue, Neonatal intensive care nurses, Stress reduction program, Non Pharmacological Intervention
Medical subject headings
Compassion Fatigue, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality HypnosisDevice

    The experimental group of 22 participants consists of a hypnosis intervention using a virtual reality device (HypnoVR®).

    Participants are seated in a quiet area of the unit:

    They choose a visual scenario from among 3 proposals, guaranteeing the conditions of a restorative environment. During each session, the same script (support mode) is spoken and the same music (serenity program with soothing tones) is associated with the script. Each participant is fitted with a virtual reality mask and a headset with active noise reduction.

  • Control arm (SEQ):Other

    Restoration time

    Participants are seated in a quiet area of the unit. The control group of 21 participants consists of a break with the following instructions and suggestions:

    "Take advantage of this break, this time just for you, to recharge your batteries. Sit in this armchair and I suggest you think of something pleasant and comfortable".

Study groups in NCT06786962
Study groupRoleWhat they receive
Control groupActive comparatorParticipants are seated in a quiet area of the unit. The control group of 21 participants consists of a break with the following instructions and suggestions: "Take advantage of this break, this time just for you, to recharge your batteries. Sit in this armchair and I suggest you think of something pleasant and comfortable".
Receives: Other: Control arm (SEQ):
VRH GroupExperimentalThe experimental group of 22 participants consists of a hypnosis intervention using a virtual reality device (HypnoVR®). Participants are seated in a quiet area of the unit: They choose a visual scenario from among 3 proposals, guaranteeing the conditions of a restorative environment. During each session, the same script (support mode) is spoken and the same music (serenity program with soothing tones) is associated with the script. Each participant is fitted with a virtual reality mask and a headset with active noise reduction.
Receives: Device: Virtual reality Hypnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stress levels

    Perceived stress: a single question on stress symptoms : "Stress is a situation in which a person feels tense, restless, nervous or anxious, or can't sleep at night because their mind is constantly troubled. Are you feeling this type of stress these days?" The answer will be recorded on a five-point Likert scale ranging from 1 (not at all) to 5 (a lot).

    Measured: From enrollment to the end of treatment at 8 weeks

  2. Emotions

    Emotions : 10 items from the short version of the Positive and Negative Affects Schedule .

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Anxiety

    State anxiety : 10 items from the short version of the State Anxiety Scale

    Measured: From enrollment to the end of treatment at 8 weeks

  4. Restoration

    Restoration: 3 items from the Mental Restoration Scale

    Measured: From enrollment to the end of treatment at 8 weeks

  5. Satisfaction and compassion fatigue

    Satisfaction and compassion fatigue: 21 items from the ProQOL - 21 scale

    Measured: From enrollment to the end of treatment at 8 weeks

  6. Comfort level

    Comfort: indicator of parasympathetic changes in emotional situations during each session, with the ANI Guardian® device.

    Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (2)
  1. Evaluation of experience

    Experience Open-ended question about the user experience during the session ("Your comments on the session"): "How did you experience this session?" Responses will be analyzed using an approach combining inductive coding and content analysis based on hypnosis processes identified in the literature

    Measured: From enrollment to the end of treatment at 8 weeks

  2. Acceptability

    To assess acceptability, participants will rate their perception of the relaxation activity using five items from the Unified Theory of Acceptance and Use of Technology (UTAUT). These items assess ease of use, usefulness, effectiveness, overall satisfaction and behavioral intention. Participants will respond on a 10-point Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree).

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start4 Nov 2024
  3. Primary completion2 Feb 2025
  4. Study completion12 Feb 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Neonatal Intensive Care Unit (NICU) Nurses (n = 42) will be randomly assigned to one of two conditions (control or Virtual Reality Hypnosis (VRH)). Each nurse will receive six 10-minute sessions of one of the techniques for 6 weeks (1 session per week).
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06786962
Sponsor's protocol ID
HYPNOVR - NEONAT
Acronym
HYPNOVRNEO
Status last verified
Feb 2025
First submitted
16 Dec 2024
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nukarinen, T., Istance, H. O., Rantala, J., Mäkelä, J., Korpela, K., Ronkainen, K., Surakka, V., & Raisamo, R. (2020). Physiological and Psychological Restoration in Matched Real and Virtual Natural Environments. Extended Abstracts of the 2020 CHI Conference on Human Factors in Computing Systems, 1-8. https://doi.org/10.1145/3334480.3382956

  • Asadollah F, Nikfarid L, Sabery M, Varzeshnejad M, Hashemi F. The Impact of Loving-Kindness Meditation on Compassion Fatigue of Nurses Working in the Neonatal Intensive Care Unit: A Randomized Clinical Trial Study. Holist Nurs Pract. 2023 Jul-Aug 01;37(4):215-222. doi: 10.1097/HNP.0000000000000590.

    PubMed 37335149
  • Boselli, E. (2018). Intérêt du monitorage du tonus parasympathique relatif par Analgesia/Nociception Index (ANI) chez les patients anesthésiés ou conscients. Douleurs : Évaluation - Diagnostic - Traitement, 19(5), 205-210. https://doi.org/10.1016/j.douler.2018.07.008

  • Bresesti I, Folgori L, De Bartolo P. Interventions to reduce occupational stress and burn out within neonatal intensive care units: a systematic review. Occup Environ Med. 2020 Aug;77(8):515-519. doi: 10.1136/oemed-2019-106256. Epub 2020 Mar 4.

    PubMed 32132183
  • Figley, C. R. (Éd.). (2015). Compassion fatigue : Coping with secondary traumatic stress disorder in those who treat the traumatized. Routledge.

  • Jess G, Pogatzki-Zahn EM, Zahn PK, Meyer-Friessem CH. Monitoring heart rate variability to assess experimentally induced pain using the analgesia nociception index: A randomised volunteer study. Eur J Anaesthesiol. 2016 Feb;33(2):118-25. doi: 10.1097/EJA.0000000000000304.

    PubMed 26266775
  • Kaplan, S. (1995). The restorative benefits of nature : Toward an integrative framework. Journal of environmental psychology, 15(3), 169-182.

  • Joinson C. Coping with compassion fatigue. Nursing. 1992 Apr;22(4):116, 118-9, 120. No abstract available.

    PubMed 1570090
  • Liang, L., Gobeawan, L., Lau, S.-K., Lin, E. S., & Ang, K. K. (2024). Urban Green Spaces and Mental Well-Being : A Systematic Review of Studies Comparing Virtual Reality versus Real Nature. Future Internet, 16(6), Article 6. https://doi.org/10.3390/fi16060182

  • Ruysschaert, N. (2009). (Self) hypnosis in the prevention of burnout and compassion fatigue for caregivers : Theory and induction. Contemporary Hypnosis (John Wiley & Sons, Inc.), 26(3), 159-172. https://doi.org/10.1002/ch.382

  • Touloudi E, Hassandra M, Galanis E, Goudas M, Theodorakis Y. Applicability of an Immersive Virtual Reality Exercise Training System for Office Workers during Working Hours. Sports (Basel). 2022 Jun 29;10(7):104. doi: 10.3390/sports10070104.

    PubMed 35878115
  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PubMed 3397865
  • Wong JQH, Charles JS, Mok HT, Tan TSZ, Amin Z, Ng YPM. Experiences of healthcare personnel with death in the neonatal intensive care unit: a systematic review of qualitative studies. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):617-622. doi: 10.1136/archdischild-2023-325566. Epub 2023 May 17.

    PubMed 37197908
  • Zhang YY, Zhang C, Han XR, Li W, Wang YL. Determinants of compassion satisfaction, compassion fatigue and burn out in nursing: A correlative meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11086. doi: 10.1097/MD.0000000000011086.

    PubMed 29952947
  • Singer T, Klimecki OM. Empathy and compassion. Curr Biol. 2014 Sep 22;24(18):R875-R878. doi: 10.1016/j.cub.2014.06.054.

    PubMed 25247366

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality Hypnosis in people with Hypnosis and Virtual Reality Therapy, run by CARESP: Cellule d'animation régionale en soins palliatifs 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress levels (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06786962, which also lists 17 linked publications.

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 14 Feb 2025.

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