Depression and Anxiety Trial, Not Yet Recruiting NCT07443111 Sponsor: Bezmialem Vakif University Condition: Depression and Anxiety
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Depression and Anxiety Trial, Not Yet Recruiting

NCT07443111
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Adults between 18 and 65 years of age.
  • People who are admitted to hospital and scheduled for planned (non-emergency) lumbar disc herniation (lower back disc) surgery, before the operation takes place.
  • People assessed by an anaesthetist as being in general health categories I, II, or III on the American Society of Anesthesiologists scale (confirm with trial site).
  • People who can read, write, and understand Turkish.
  • People who have sufficient mental clarity to understand the consent form — meaning no advanced dementia, severe communication difficulties, impaired consciousness, or neurological or psychiatric conditions that would interfere with understanding.
  • People who are willing to complete an anxiety questionnaire about surgery and provide a saliva sample using a non-invasive method.
  • People without severe vision problems that would prevent use of a virtual reality (VR) headset — vision problems that can be corrected with glasses or contact lenses are acceptable.
  • People who provide written and verbal consent to participate.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who need emergency or urgent brain or spinal surgery (for example, due to acute bleeding or severe head injury).
  • People with a diagnosed history of epilepsy, especially epilepsy triggered by flashing lights or visual patterns.
  • People with severe cognitive (thinking or memory) impairment, severe communication difficulties, inability to cooperate, or reduced consciousness.
  • People who have been admitted to a psychiatric facility within the last 6 months due to a serious psychiatric condition such as psychosis, bipolar disorder, or severe major depression.
  • People who take steroid medications long-term, or who have a hormonal condition that significantly affects adrenal gland function (such as Cushing's syndrome or Addison's disease).
  • People with untreated severe thyroid disease that may affect certain hormone levels measured in the study.
  • People with a history of severe dizziness or balance disorders, or who have previously had a bad reaction to visual experiences similar to virtual reality.
  • People with severe vision problems that cannot be corrected with glasses or contact lenses, making it impossible to see VR content properly.
  • People who are unable to complete the VR session due to nausea, dizziness, or similar symptoms during headset use — in these cases, the intervention would be stopped and the person would be withdrawn from the study.
  • People with severe mouth sores, a serious active mouth infection, or a significant problem with their salivary glands that would interfere with saliva collection.
  • People who are pregnant or may be pregnant.
  • People who have taken part in another clinical trial or VR-based study within the last 3 months.
  • People who withdraw their consent during the study, or whose scheduled surgery is cancelled or postponed.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: NURGÜL ARPAG, Assistant Professor,PhD, RN, Bezmialem Vakif University

Phone: +90 212 401 26 00

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Bezmialem Vakif University
Registry
ClinicalTrials.gov
Start date
27 February 2026
Est. completion
27 April 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

Change in Surgical Anxiety Level (SAQ Total Score); Change in Salivary Cortisol Level

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov