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Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers

Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "ARM A: Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes three times a week (TIW) for 6-7 weeks then weekly for 4 weeks."
  • "ARM B: Participants receive 2D non-immersive VR headset consisting of 2 scenarios - walk in the nature and beach TIW for 6-7 weeks then weekly for 4 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and/or stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C/RT), and their caregivers. HNC patients undergoing C/RT can experience higher levels of depression, anxiety, distress and pain that negatively impact their quality of life. VR allows for a realistic experience and works as an effective distraction tool from the state of pain or anxiety without use of drugs and with minimal associated risk to patients. VR has been shown to help reduce symptoms of depression, anxiety and pain in non-cancer patients, however there is limited evidence of how well VR use works in cancer patients, especially in patients undergoing C/RT for HNC. Caregivers of these patients also experience high levels of anxiety and distress. Using VR interventions may improve depression, anxiety, pain and/or stress in patients with HNC undergoing C/RT and their caregivers.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * PATIENTS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * PATIENTS: ≥ 18 years * PATIENTS: Self-reported normal or corrected to normal vision and hearing * PATIENTS: Ambulatory (permitted to use walking aids such as cane or crutch) * PATIENTS: Ability to read and understand English for questionnaires * PATIENTS: Scheduled to undergo C/RT for their HNC * CAREGIVERS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * CAREGIVERS: ≥ 18 years * CAREGIVERS: Self-reported normal or corrected to normal vision and hearing * CAREGIVERS: Ability to read and understand English for questionnaires * CAREGIVERS: A care giver identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care Exclusion Criteria: * PATIENTS: An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager * PATIENTS: A direct study team member * PATIENTS: Inability to complete the surveys * PATIENTS: Serious mental illness * PATIENTS: Previous head and neck cancer treatment * PATIENTS: History of any psychiatric disease treatment with anti-depressants, substance abuse, post-traumatic stress disorder (PTSD), chronic pain (\> 3 months) * PATIENTS: Cancer in or around the eyes or ears; visual, hearing or cognitive impairment * CAREGIVERS: An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager * CAREGIVERS: A direct study team member * CAREGIVERS: Inability to complete the surveys * CAREGIVERS: Serious mental illness * CAREGIVERS: History of any psychiatric disease treatment with anti-depressants, substance abuse, PTSD

Study sites (1)

CA