NCT06786962

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 4, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

December 16, 2024

Last Update Submit

February 12, 2025

Conditions

Keywords

HypnosisVirtual realityStressCompassion fatigueNeonatal intensive care nursesStress reduction programNon Pharmacological Intervention

Outcome Measures

Primary Outcomes (6)

  • 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).

    From enrollment to the end of treatment at 8 weeks

  • Emotions

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

    From enrollment to the end of treatment at 8 weeks

  • Anxiety

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

    From enrollment to the end of treatment at 8 weeks

  • Restoration

    Restoration: 3 items from the Mental Restoration Scale

    From enrollment to the end of treatment at 8 weeks

  • Satisfaction and compassion fatigue

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

    From enrollment to the end of treatment at 8 weeks

  • Comfort level

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

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Evaluation of experience

    From enrollment to the end of treatment at 8 weeks

  • Acceptability

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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".

Other: Control arm (SEQ):

VRH Group

EXPERIMENTAL

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.

Device: Virtual reality Hypnosis

Interventions

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.

VRH Group

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".

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RENNES

Rennes, Brittany Region, 35000, France

Location

Related Publications (17)

  • 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

    RESULT
  • 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.

  • 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

    RESULT
  • 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.

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

    RESULT
  • 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.

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

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

  • 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

    RESULT
  • 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

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

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

  • Ruiz-Fernandez MD, Perez-Garcia E, Ortega-Galan AM. Quality of Life in Nursing Professionals: Burnout, Fatigue, and Compassion Satisfaction. Int J Environ Res Public Health. 2020 Feb 15;17(4):1253. doi: 10.3390/ijerph17041253.

  • Boselli E, Musellec H, Bernard F, Guillou N, Hugot P, Augris-Mathieu C, Diot-Junique N, Bouvet L, Allaouchiche B. EFFECTS OF CONVERSATIONAL HYPNOSIS ON RELATIVE PARASYMPATHETIC TONE AND PATIENT COMFORT DURING AXILLARY BRACHIAL PLEXUS BLOCKS FOR AMBULATORY UPPER LIMB SURGERY:A Quasiexperimental Pilot Study. Int J Clin Exp Hypn. 2018 Apr-Jun;66(2):134-146. doi: 10.1080/00207144.2018.1421355.

Related Links

MeSH Terms

Conditions

Compassion FatigueAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, PsychologicalMental Disorders

Study Officials

  • Estelle MICHINOV, PhD

    University of Rennes 2

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

January 22, 2025

Study Start

November 4, 2024

Primary Completion

February 2, 2025

Study Completion

February 12, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations