Virtual Reality Hypnosis and Nurses' Stress (HYPNOVRNEO)

February 12, 2025 updated by: CARESP: Cellule d'animation régionale en soins palliatifs

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • RENNES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group

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):

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".
Experimental: VRH Group

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress levels
Time Frame: From enrollment to the end of treatment at 8 weeks
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
Time Frame: From enrollment to the end of treatment at 8 weeks
Emotions : 10 items from the short version of the Positive and Negative Affects Schedule .
From enrollment to the end of treatment at 8 weeks
Restoration
Time Frame: From enrollment to the end of treatment at 8 weeks
Restoration: 3 items from the Mental Restoration Scale
From enrollment to the end of treatment at 8 weeks
Satisfaction and compassion fatigue
Time Frame: From enrollment to the end of treatment at 8 weeks
Satisfaction and compassion fatigue: 21 items from the ProQOL - 21 scale
From enrollment to the end of treatment at 8 weeks
Comfort level
Time Frame: From enrollment to the end of treatment at 8 weeks
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
Anxiety
Time Frame: From enrollment to the end of treatment at 8 weeks
State anxiety : 10 items from the short version of the State Anxiety Scale
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of experience
Time Frame: From enrollment to the end of treatment at 8 weeks
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
From enrollment to the end of treatment at 8 weeks
Acceptability
Time Frame: From enrollment to the end of treatment at 8 weeks
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).
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CARESP: Cellule d'animation régionale en soins palliatifs

Collaborators

University of Rennes 2

Investigators

  • Study Director: Estelle MICHINOV, PhD, University of Rennes 2

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Actual)

February 2, 2025

Study Completion (Actual)

February 12, 2025

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYPNOVR - NEONAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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