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NCT Number: NCT06485869

Impact of Virtual Reality on the Quality of Life of Oncology Patients

Anxiety, nausea and vomiting are common side effects in paediatric patients receiving chemotherapy. chemotherapy. New evidence supports the efficacy of immersive virtual reality in improving symptoms of anxiety and distress, including nausea and vomiting, in this vulnerable group. This research will evaluate the efficacy of virtual reality in managing anxiety, nausea and vomiting in cancer patients receiving their first line of chemotherapy and will also measure the quality of life of these patients and evaluate patient and nursing staff satisfaction

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Chauny, Chauny, France

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About this study

For cancer patients, virtual reality proved more effective than other forms of distraction in relieving anxiety, depression and fatigue during chemotherapy. Although pain and anxiety in cancer patients are managed proactively, this study was designed to measure the quality of life of these patients, assess patient and carer satisfaction, evaluate the effectiveness of virtual reality in reducing anxiety during the first three sessions of chemotherapy, and assess the impact of virtual reality on preventive and acute chemotherapy-induced fatigue, nausea and vomiting.

This is a clinical study with a therapeutic aim using a non-medicinal, interventional, prospective, multi-centre, controlled and randomised technique, with two parallel groups. It is clinical research involving the human person category 2, involving only minimal risks and constraints. The two arms are Arm A: study questionnaires with virtual reality (VR) Arm B: study questionnaires without virtual reality, standard care (SC)

A visit will be made during the 3 cycles of chemotherapy during which arm A will be immersed in Virtual Reality with the Healthy Mind VR programme.

programme, and patients in arm B will receive standard care without hypnotic support.

There will also be a pre-inclusion visit 7 days before the first cycle. and visits at 3, 6 and 9 months after the 3 cycles of chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chemotherapy-naive patient
  • Patient with first-line indication for intravenous cyclic chemotherapy
  • Affiliated to a social security system
  • Having received full information on the organization of the research and having given free, informed and written consent signed by the participant and the investigator
  • Patient understands French or English
  • Expected duration of chemotherapy session for the first 3 cycles greater than 30 minutes

Exclusion criteria

  • Patient with communication disorders preventing informed consent
  • Patient under legal protection (guardianship, curatorship, safeguard of justice)
  • Patients suffering from epilepsy
  • Severe visual or hearing impairment preventing use of headphones
  • Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
  • Patients with infections or facial wounds
  • Patients with severe claustrophobia
  • Patients with pacemakers
  • Patients with known cognitive or learning problems,
  • Patients with brain tumors or metastases,
  • Patients suffering from motion sickness
  • Expected duration of chemotherapy session for the first 3 cycles of 30 minutes or less.

Treatment and study plan

Measure the improvement in quality of life

Other

Improvment of quality of life is measured by the QLQ-C30 quality of life questionnaire

Measure the level of satisfaction of patients and nursing staff

Other

Patient satisfaction is measured using a five-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate higher levels of satisfaction.

Measurement of anxiety and pain

Other

Anxiety and pain is measured by Visual Analogue Scale (VAS). This measurement is complemented by physiological responses to anxiety, measured by heart rate and mean arterial blood pressure (HR and BP)

Measurement of depressive state

Other

Depressive State is measured by HAD score

measuring fatigue levels

Other

Fatigue levels is measured by Visual Analogue Scale (VAS).

measurement of acute nausea and vomiting

Other

acute nausea and vomiting is measured by MASCC Antiemesis Tool (MAT)

Primary outcomes

  1. QLQ-C30

    Time frame: at the start of cycle 1 (each cycle is 28 days); 3,6,9 months post chemo, at the beginning of the 3rd month post chemo, at the beginning of the 6th month post chemo and at the beginning of the 9th month post chemo

    Measurement of the quality of life observed in patients. The QLQ-C30 questionnaire consists of 30 questions on the patient's state of physical and mental health. There are 28 questions with scores ranging from 1 = not at all to 4= very much and two questions with scores ranging from 1= very poor to 7= excellent.

  2. Measuring patient and nurse satisfaction with the chemotherapy procedure

    Time frame: after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days)

    Use of a patient questionnaire with a 10-point scale assessed on a five-point scale ranging from 1=strongly disagree disagree to 5 = strongly agree

  3. MAT

    Time frame: after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days)

    Assessment of acute nausea and vomiting in patients induced by chemotherapy. 4 questions are used to assess nausea and vomiting 24 hours after chemotherapy and these 4 questions are again used to assess late nausea and vomiting.

    There are 2 questions with a yes or no choice, 1 question with a numerical answer and 1 question with a 10-point numerical scale with 0= none and 10= maximum difficulty.

Secondary outcomes

  1. VAS Score

    Time frame: Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).

    Measures patients' anxiety and pain levels, as well as their fatigue levels. This questionnaire consists of 4 questions on pain levels, anxiety, fatigue and satisfaction with treatment. It is administered before and after chemotherapy.

    A 10-point numerical scale is used, with 0= the minimum and 10 =the maximum.

  2. Heart rate

    Time frame: Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).

    Measurement of heart rate in bpm. To assess the patient's level of anxiety and pain. Use of a multiparametric monitor. It will be collected before and after virtual reality.

  3. Blood pressure

    Time frame: Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).

    Measurement of blood pressure in mmHg. To assess the patient's level of anxiety and pain. Use of a multiparametric monitor. It will be collected before and after virtual reality.

  4. HAD Score

    Time frame: Before the start of the first chemotherapy session on day 1 of cycle 1 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1 and 2 (each cycle is 28 days).

    Assessment of the patient's state of depression and anxiety. There are 14 questions with scores ranging from 0 to 3 and different answer choices depending on the type of question.

Study contacts

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

Abdelkrim Mr Boulanouar

CONTACT

[email protected]

0323067886

Frédérique Mm Roussel

CONTACT

[email protected]

0323067901

Sponsors and collaborators

Lead sponsor

Central Hospital Saint Quentin

Other Gov

Registry information

Acronym: VIRONSCARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

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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