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Trial registered on ANZCTR
Registration number
ACTRN12626001245381
Ethics application status
Approved
Date submitted
23/09/2026
Date registered
14/10/2026
Date last updated
14/10/2026
Date data sharing statement initially provided
14/10/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
IRIES: Immersive virtual Reality during transvaginal ultrasound In people with EndometriosiS — Protocol for a mixed-methods randomised pilot and feasibility trial
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Scientific title
IRIES: Immersive virtual Reality during transvaginal ultrasound In people with EndometriosiS — Protocol for a mixed-methods randomised pilot and feasibility trial
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Additional trial identifiers [1]
318313
0
n/a
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
endometriosis
343685
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Condition category
Condition code
Reproductive Health and Childbirth
339806
339806
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0
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
339890
339890
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0
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Arm 1 – Virtual reality intervention:
Participants allocated to the intervention group will undergo a standard transvaginal ultrasound (TVUS) while using the Smileyscope Lume immersive virtual reality (VR) system. The intervention will be delivered face-to-face at Specialist Imaging Partners by a sonographer trained in the use of the VR system. Before the examination, the sonographer will explain the device, fit and adjust the VR system, confirm participant comfort and ensure verbal communication can be maintained. Participants will view a standardised relaxation program featuring immersive visual content, including landscapes, nature, animals and underwater environments, accompanied by relaxing music. The audio will be played through the device’s speakers, with the volume adjusted as needed to allow ongoing communication between the participant and sonographer. A chaperone will also be present during the examination. The VR experience will commence immediately before or at the start of the TVUS and continue for the duration of the examination (approximately 60 minutes). Participants will receive the intervention once, during their scheduled TVUS. Participants may request adjustment or removal of the VR device at any time. Intervention delivery, including completion, interruptions, discontinuation, technical issues and adverse effects, will be documented by the sonographer.
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Intervention code [1]
335408
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Treatment: Devices
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Description of the comparator or control
Participants allocated to the control group will undergo standard transvaginal ultrasound (TVUS) without immersive virtual reality. The TVUS will be delivered face-to-face at Specialist Imaging Partners by a qualified sonographer and will take approximately 60 minutes. The examination will follow routine clinical practice, including standard explanations, communication and comfort measures, with participants able to pause or stop the examination at any time. No additional comparator intervention or adherence requirements apply.
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Control group
Active
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Outcomes
Primary outcome [1]
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Recruitment feasibility
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Assessment method [1]
346979
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Number of individuals expressing interest, screened, eligible, consented and randomised, and recruitment rate calculated from study recruitment records.
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Timepoint [1]
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Throughout the recruitment period.
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Primary outcome [2]
346980
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Participant retention
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Assessment method [2]
346980
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Study records will be used to determine the proportion of randomised participants who complete the study transvaginal ultrasound and post-procedure study assessments.
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Timepoint [2]
346980
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Baseline and immediately after the transvaginal ultrasound.
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Primary outcome [3]
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Successful delivery of the virtual reality intervention as intended
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Assessment method [3]
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The sonographer study procedure form will be used to determine the proportion of participants allocated to the intervention group who commence and complete the virtual reality intervention as intended during the transvaginal ultrasound.
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Timepoint [3]
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During and immediately after the transvaginal ultrasound.
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Secondary outcome [1]
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Pain intensity
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Assessment method [1]
468453
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11-point Numeric Rating Scale (0 = no pain; 10 = worst pain imaginable) and Visual Analogue Scale.
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Timepoint [1]
468453
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Immediately before the transvaginal ultrasound; retrospectively for the highest pain experienced during the examination; and immediately after the examination.
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Secondary outcome [2]
468454
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State anxiety
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Assessment method [2]
468454
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Six-item short form of the State-Trait Anxiety Inventory.
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Timepoint [2]
468454
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Immediately before the transvaginal ultrasound; retrospectively for anxiety experienced during the examination; and immediately after the examination.
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Secondary outcome [3]
468455
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Procedural distress
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Assessment method [3]
468455
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Single-item 0–10 rating scale assessing emotional distress associated with the transvaginal ultrasound.
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Timepoint [3]
468455
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Immediately before the transvaginal ultrasound and immediately after the examination, with the post-procedure assessment referring to distress experienced during the examination.
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Secondary outcome [4]
468456
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Perceived control
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Assessment method [4]
468456
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Single-item 0–10 rating scale assessing perceived control during the transvaginal ultrasound.
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Timepoint [4]
468456
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Immediately before the transvaginal ultrasound (expected control) and immediately after the examination (experienced control during the procedure)
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Secondary outcome [5]
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Data completeness
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Assessment method [5]
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Study records and participant questionnaire data will be used to determine the proportion of required study measures completed at each assessment timepoint. This is not a questionnaire, but an outcome measure. We will measure the completeness of the above mentioned used tools at both time points. Data completeness will not be assessed using a questionnaire, as it is an objective measure rather than a participant-reported outcome. It will be assessed by reviewing the proportion of expected data collected across the study questionnaires and outcome measures. As such, a validated questionnaire is neither required nor applicable for this outcome. Data completeness will be calculated as the percentage of required data fields completed out of the total number of expected fields, excluding those that are not applicable. This will be assessed separately for each data collection instrument and time point (baseline and post-TVUS), using the following formula: Data completeness (%) = (Number of completed required fields / Total number of expected required fields) × 100. Completeness will be assessed using the collected study data rather than a separate questionnaire.
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Timepoint [5]
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Baseline and immediately following the transvaginal ultrasound.
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Secondary outcome [6]
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Data completeness of the State-Trait Anxiety Inventory (STAI-6) at baseline
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Assessment method [6]
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Data completeness will be assessed as the percentage of participants who provide complete STAI-6 questionnaire data at baseline. This will be calculated by dividing the number of participants with all six STAI-6 items completed by the total number of participants expected to complete the questionnaire (n = 20), multiplied by 100.
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Timepoint [6]
469200
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Baseline (prior to transvaginal ultrasound).
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Secondary outcome [7]
469201
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Data completeness of the State-Trait Anxiety Inventory (STAI-6) post-transvaginal ultrasound
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Assessment method [7]
469201
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Data completeness will be assessed as the percentage of participants who provide complete STAI-6 questionnaire data immediately following transvaginal ultrasound. This will be calculated by dividing the number of participants with all six STAI-6 items completed by the total number of participants expected to complete the questionnaire (n = 20), multiplied by 100.
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Timepoint [7]
469201
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Immediately following transvaginal ultrasound.
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Secondary outcome [8]
469202
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Data completeness of the 11-point Numeric Rating Scale (NRS-11) at baseline
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Assessment method [8]
469202
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Data completeness will be assessed as the percentage of participants who provide complete NRS-11 pain assessment data at baseline. This will be calculated by dividing the number of participants with a completed NRS-11 pain assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [8]
469202
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Baseline, prior to transvaginal ultrasound.
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Secondary outcome [9]
469203
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Data completeness of the 11-point Numeric Rating Scale (NRS-11) post-transvaginal ultrasound
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Assessment method [9]
469203
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Data completeness will be assessed as the percentage of participants who provide complete NRS-11 pain assessment data immediately following transvaginal ultrasound. This will be calculated by dividing the number of participants with a completed NRS-11 pain assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [9]
469203
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Immediately following transvaginal ultrasound.
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Secondary outcome [10]
469204
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Data completeness of the Visual Analogue Scale (VAS) at baseline
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Assessment method [10]
469204
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Data completeness will be assessed as the percentage of participants who provide complete VAS pain assessment data at baseline. This will be calculated by dividing the number of participants with a completed VAS pain assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [10]
469204
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Baseline, prior to transvaginal ultrasound.
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Secondary outcome [11]
469205
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Data completeness of the Visual Analogue Scale (VAS) post-transvaginal ultrasound
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Assessment method [11]
469205
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Data completeness will be assessed as the percentage of participants who provide complete VAS pain assessment data immediately following transvaginal ultrasound. This will be calculated by dividing the number of participants with a completed VAS pain assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [11]
469205
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Immediately following transvaginal ultrasound.
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Secondary outcome [12]
469206
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Data completeness of procedural distress assessment at baseline
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Assessment method [12]
469206
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Data completeness will be assessed as the percentage of participants who provide complete anticipatory procedural distress assessment data at baseline. This will be calculated by dividing the number of participants with a completed anticipatory procedural distress assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [12]
469206
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Baseline, prior to transvaginal ultrasound.
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Secondary outcome [13]
469207
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Data completeness of procedural distress assessment post-transvaginal ultrasound
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Assessment method [13]
469207
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Data completeness will be assessed as the percentage of participants who provide complete procedural distress assessment data immediately following transvaginal ultrasound. This will be calculated by dividing the number of participants with a completed procedural distress assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [13]
469207
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Immediately following transvaginal ultrasound.
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Secondary outcome [14]
469208
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Data completeness of perceived control assessment at baseline
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Assessment method [14]
469208
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Data completeness will be assessed as the percentage of participants who provide complete expected perceived control assessment data at baseline. This will be calculated by dividing the number of participants with a completed expected perceived control assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [14]
469208
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Baseline, prior to transvaginal ultrasound.
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Secondary outcome [15]
469209
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Data completeness of perceived control assessment post-transvaginal ultrasound
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Assessment method [15]
469209
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Data completeness will be assessed as the percentage of participants who provide complete perceived control assessment data immediately following transvaginal ultrasound. This will be calculated by dividing the number of participants with a completed perceived control assessment by the total number of participants expected to complete the assessment (n = 20), multiplied by 100.
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Timepoint [15]
469209
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Immediately following transvaginal ultrasound.
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Eligibility
Key inclusion criteria
Adult women aged 18 years or older with a confirmed diagnosis of endometriosis who are willing to attend a study-funded transvaginal ultrasound at Specialist Imaging Partners, are able to provide informed consent, and have sufficient written and spoken English to complete the study questionnaires and participate in an interview.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Healthy volunteers
No
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Key exclusion criteria
History of epilepsy or seizure disorder; presence of a programmable shunt; inability or unwillingness to undergo transvaginal ultrasound; inability to provide informed consent; or insufficient English proficiency to complete the study procedures.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using a computer-generated randomisation schedule with randomly permuted blocks, prepared before recruitment by a researcher who is not responsible for participant enrolment or baseline data collection. Block sizes will not be disclosed to staff involved in enrolment, and the randomisation schedule will be stored in a password-protected file with restricted access. Allocation will only be revealed after informed consent, eligibility confirmation and completion of baseline data collection.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence using randomly permuted blocks will be used, with participants allocated in a 1:1 ratio to the intervention or control group. Block sizes will not be disclosed to staff involved in participant enrolment.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
A formal sample size calculation was not undertaken because this is a pilot and feasibility trial and is not powered to detect clinically meaningful between-group differences. A target sample of 20 participants (10 per arm) was selected to assess recruitment, randomisation, intervention delivery, retention and data collection procedures, and to obtain preliminary estimates of variability to inform a future definitive trial.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/11/2026
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Actual
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Date of last participant enrolment
Anticipated
26/02/2027
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Actual
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Date of last data collection
Anticipated
2/04/2027
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Stream C - College of Health Strategic Research Initiative - Adelaide University
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Address [1]
322873
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Country [1]
322873
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Australia
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Primary sponsor type
University
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Name
Adelaide University
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Address
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Country
Australia
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Secondary sponsor category [1]
325800
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None
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Name [1]
325800
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Address [1]
325800
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Country [1]
325800
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Other collaborator category [1]
284105
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Commercial sector/Industry
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Name [1]
284105
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Smileyscope
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Address [1]
284105
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Country [1]
284105
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
321307
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
321307
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https://bellberry.com.au/
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Ethics committee country [1]
321307
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Australia
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Date submitted for ethics approval [1]
321307
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04/09/2026
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Approval date [1]
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01/10/2026
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Ethics approval number [1]
321307
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2026-09-1598
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Summary
Brief summary
Transvaginal ultrasound is commonly used to assess endometriosis, but the examination can be associated with pain, anxiety and emotional distress. This study aims to find out whether using immersive virtual reality during transvaginal ultrasound is feasible, acceptable and safe for women with endometriosis. Twenty women will be randomly assigned to have either a standard transvaginal ultrasound or a transvaginal ultrasound while using immersive virtual reality. The study will assess whether participants can be recruited and retained, whether virtual reality can be successfully used during the examination, and whether the study procedures are practical and acceptable. It will also explore participants' experiences of pain, anxiety, distress and control to help inform the design of a larger future trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
153306
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Dr Anna Fragkoudi
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Address
153306
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Adelaide University, 4 North Terrace, Adelaide, SA 5000
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Country
153306
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Australia
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Phone
153306
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+61 8 8313 4273
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Fax
153306
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Email
153306
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[email protected]
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Contact person for public queries
Name
153307
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Anna Fragkoudi
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Address
153307
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Adelaide University, 4 North Terrace, Adelaide, SA 5000
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Country
153307
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Australia
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Phone
153307
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+61 8 8313 4273
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Fax
153307
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Email
153307
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[email protected]
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Contact person for scientific queries
Name
153308
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Anna Fragkoudi
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Address
153308
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Adelaide University, 4 North Terrace, Adelaide, SA 5000
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Country
153308
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Australia
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Phone
153308
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+61 8 8313 4273
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Fax
153308
0
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Email
153308
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Individual participant data will not be shared as this is a small pilot and feasibility study. The study data will be used to inform the design and conduct of a future definitive trial. Study findings will be disseminated through peer-reviewed publications and conference presentations in aggregated and de-identified form.
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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