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Wound SurgicalNCT05744024

Non-pharmacological Pain Care During Complex Wound Care Procedures

A study testing Virtual Reality system and Headphones in people with Wound Surgical and Wounds and Injuries, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The main objective of this study is to evaluate the effect on pain and both Virtual Reality and Music Therapy as add-on therapy during wound car in adults. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Virtual Reality system and Headphones
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteNetherlands
Study dates
17 Nov 2022to 17 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals aged 18 or older who have wounds receiving wound care
  • Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures before discharge
  • At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.

Who cannot join

  • Individuals not being able to understand Dutch language at primary school level
  • Individuals not being able to read or write Dutch
  • Individuals diagnosed with dementia and/or cognitive impairment
  • Individuals diagnosed with epilepsy
  • Individuals diagnosed with migraine
  • Individuals with severe dizziness and/or nausea
Show all 10Show fewer
  • Individuals with a known history of claustrophobia
  • Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
  • Individuals who have no feeling in the wound care area
  • Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site

  • Amsterdam University Medical Center

    Amsterdam, North Holland, 1105AZ

Other trials in Netherlands

About this study

Official title: Non-pharmacological Pain Care Using Virtual Reality Therapy or Music Therapy During Complex Wound Care in Adults

The main objective of this study is to evaluate the effect on pain and both Virtual Reality and Music Therapy as add-on therapy during wound car in adults.

Read the detailed description

After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system or headphone with audio during wound care or not wearing the VR system or headphone with audio.

Patients are randomly assigned to one of three groups:

Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Intervention group 2, Music Therapy Group 3 - Control group, care as usual

Being tested
Virtual Reality system, Headphones
Medical subject headings
Surgical Wound, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality systemDevice

    The intervention group 1 will be wearing the 'SyncVR' Virtual Reality system during the wound care moment in addition to the standard procedure. The VR system consists of Virtual Reality glasses, a controller, and a headphone. The SyncVR Relax \& Distract Application (SyncVR R\&D) will be used.

  • HeadphonesOther

    Headphones with audio. The patients will be hearing their preferred audio, chosen by patient to relaxing and to offer distraction, through headphones during wound care.

Study groups in NCT05744024
Study groupRoleWhat they receive
Virtual Reality Therapy (Intervention group 1)ExperimentalIn addition to the standard wound care procedure, the Virtual Reality Therapy group (intervention group 1) will receive the VR system during the wound care. The VR system consists of Virtual Reality glasses, a controller and a headphone. The application SyncVR Relax \& Distract will be used, which will contain various videos for the patient those from to relax and be distracted. This group wears the VR system 10 minutes before the start of the wound care, until 1 minute after the wound care has ended.
Receives: Device: Virtual Reality system
Music Therapy (Intervention group 2)ExperimentalIn addition to the standard wound care procedure, the Music Therapy group (intervention group 2) will be hearing their preferred audio, chosen by patient to be relaxing and to offer distraction, through headphones during wound care. This group wears the headphone with music 10 minutes before the start of the wound care, until 1 minute after the wound care has ended.
Receives: Other: Headphones
Care as usual (control group/group 3)No interventionThe care as usual group (control group) will receive the care as usual. This group receives neither VRT nor MT during wound care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).

    The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.

    Measured: Baseline, during the procedure, immediately after procedure

Secondary outcomes (12)

  1. Mean VAS change of all wound care procedures included in the study

    The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.

    Measured: Baseline, during the procedure, immediately after procedure

  2. Change from baseline in level of anxiety at 10 minutes after procedure

    Level of anxiety, as measured by a Dutch translated and validated modification of the Spielberger State-Trait Inventory-6 (STAI-6) questionnaire 10 minutes before and 10 minutes after each three wound care moments.

    Measured: Baseline, 10 minutes after procedure

  3. Patient satisfaction

    Patient satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.

    Measured: Through study completion, an average of 1 week

  4. Provider satisfaction

    Provider satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.

    Measured: Through study completion, an average of 1 year

  5. Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure

    The systolic blood pressure and diastolic blood pressure 5 minutes before the intervention (intervention group)/wound care (control group) and 5 minutes after the intervention (intervention group)/wound care (control group)

    Measured: Baseline, 5 minutes after procedure

  6. Change of systolic blood pressure and diastolic blood pressure during procedure

    The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure

    Measured: During procedure

  7. Change from baseline blood oxygen level at 5 minutes after procedure

    The blood oxygen level, measured using a pulse oximetry device, 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)

    Measured: Baseline, 5 minutes after procedure

  8. Change of blood oxygen level during procedure

    The blood oxygen level every 5 minutes during procedure, measured using a pulse oximetry device

    Measured: During procedure

  9. Change from baseline pulse rate at 5 minutes after procedure

    The pulse rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)

    Measured: Baseline, 5 minutes after procedure

  10. Change of pulse rate during procedure

    The pulse rate every 5 minutes during procedure

    Measured: During procedure

  11. Change from baseline respiratory rate at 5 minutes after procedure

    The respiratory rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)

    Measured: Baseline, 5 minutes after procedure

  12. Change of respiratory rate during procedure

    The respiratory rate every 5 minutes during procedure

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start17 Nov 2022
  3. Primary completion17 Nov 2025 (estimated)
  4. Study completion17 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05744024
Sponsor's protocol ID
NL82062.018.22
Status last verified
Jan 2025
First submitted
12 Dec 2022
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality system and Headphones in people with Wound Surgical and Wounds and Injuries, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS). (time frame: Baseline, during the procedure, immediately after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05744024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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