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NCT Number: NCT06883786

Effects of Virtual Reality Hypnosis on Anxiety, Pain and Comfort in Oncology Patients During a Port-catheter Placement Procedure

The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR de Huy, Huy, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Low auditory and/or visual acuity precludes the use of the device.
  • Head or face wounds precluding the use of the device.
  • Schizophrenia, dissociative disorder or any other psychiatric disorder.
  • Non-proficiency in French (Research language).
  • Patient under 18 years old.
  • Phobia of deep water.
  • Dizziness.

Treatment and study plan

Virtual Reality Hypnosis

Device

Virtual reality hypnosis

Primary outcomes

  1. Anxiety state

    Time frame: Before PAC intervention, immediately after PAC intervention

    Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).

  2. Pain intensity

    Time frame: Before PAC intervention, immediately after PAC intervention

    Pain intensity will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  3. Pain unpleasantness

    Time frame: Before PAC intervention, immediately after PAC intervention

    Pain unpleasantness will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  4. Comfort

    Time frame: Before PAC intervention, immediately after PAC intervention

    Comfort will be assessed using a numerical rating scale (NRS) ranging from 0 (no comfort) to 10 (maximum comfort).

Secondary outcomes

  1. Anxiety trait

    Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks

    The State-Trait Anxiety Inventory (STAI - Y) will be used to assess trait anxiety only. Originally this questionnaire has two parts one dedicated to assess state anxiety and another to assess the trait anxiety. Only the latter was used in this study. STAI - Y Trait contains 20 items with 4 response options (1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). Total scores can range from 20 to 80, with higher scores indicating a higher level of anxiety.

  2. Dissociation trait

    Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks

    The Dissociative Experience Scale is a self-reported questionnaire used to evaluate the presence, quantity, and type of dissociative experiences one might live in daily life. It consists of 28 items arranged on an analog scale (from 0 to 100% measuring the frequency of dissociative experiences), and the total score ranges from 0 to 100. There is a cutoff of 45 as a mean score to suggest a dissociative disorder. This questionnaire is not a diagnostic instrument; it is designed only for screening, but it can suggest that a specific clinical assessment is needed.

  3. Dissociation state

    Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

    Dissociation will be assessed using a numerical rating scale (NRS) ranging from 0 (no dissociation) to 10 (maximum dissociation).

  4. Absorption trait

    Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks

    The Tellegen Absorption Scale consists of 34 true/false items , aiming to measure the absorption of a person, meaning the disposition for having episodes of a deep involvement that engage all the subject's resources (perceptual, imaginative, and cognitive). The total score range is from 0 to 34. The higher the score, the more one has a high propensity for absorption.

  5. Absorption state

    Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

    Absorption will be assessed using a numerical rating scale (NRS) ranging from 0 (no Absorption) to 10 (maximum Absorption).

  6. Time perception

    Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

    Time perception will be assessed with an open-ended question.

  7. Immersion tendencies

    Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks

    Immersion propensity is the amount of sensory input the virtual reality system creates. Will be assessed with the Immersion Propensity questionnaire. The higher the score, the more one is immersed in the virtual environments.

  8. Satisfaction of the participant

    Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

    Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).

  9. Satisfaction of the surgeon

    Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

    Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).

  10. Medication

    Time frame: During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC

    The medication will be collected in the medical record of the surgery.

  11. Surgery duration

    Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks

    The duration of the surgery will be collected in the medical record of the surgery.

  12. Fatigue

    Time frame: 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC

    Fatigue will be assessed using a numerical rating scale (NRS) ranging from 0 (no fatigue) to 10 (worst fatigue ever).

Study contacts

Contact information is provided by the study sponsor or research team.

Aminata Bicego, PhD

CONTACT

[email protected]

+32 43 66 34 99

Audrey Vanhaudenhuyse, PhD

CONTACT

[email protected]

+ 32 43 23 80 33

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • Centre Hospitalier Regional de Huy
  • HypnoVR
  • University hospital of Liège

Registry information

Official study title

Interest of Virtual Reality Hypnosis to Decrease Anxiety, Pain, and Discomfort of Patients With Cancer Having to Undergo an Invasive Intervention

Acronym: VRH-PAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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