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Enrolling by Invitation

NCT Number: NCT05744024

Non-pharmacological Pain Care During Complex Wound Care Procedures

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.

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Key information

Conditions

Wound Surgical Music Therapy Surgical Wound Virtual Reality Wound Care Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Virtual Reality system

Device

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.

Headphones

Other

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.

Primary outcomes

  1. 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

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

Secondary outcomes

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

    Time frame: Baseline, during the procedure, immediately after procedure

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

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

    Time frame: Baseline, 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.

  3. Patient satisfaction

    Time frame: Through study completion, an average of 1 week

    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''.

  4. Provider satisfaction

    Time frame: Through study completion, an average of 1 year

    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''.

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

    Time frame: Baseline, 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)

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

    Time frame: During procedure

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

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

    Time frame: Baseline, 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)

  8. Change of blood oxygen level during procedure

    Time frame: During procedure

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

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

    Time frame: Baseline, 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)

  10. Change of pulse rate during procedure

    Time frame: During procedure

    The pulse rate every 5 minutes during procedure

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

    Time frame: Baseline, 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)

  12. Change of respiratory rate during procedure

    Time frame: During procedure

    The respiratory rate every 5 minutes during procedure

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2023
Registry last updated
Jan 30, 2025

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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