Non-pharmacological Pain Care During Complex Wound Care Procedures

NCT05744024 | Enrolling By Invitation DMC

• 1 other identifier: NL82062.018.22
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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).

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

  Baseline, during the procedure, immediately after procedure

Secondary Outcomes (12)

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

  Baseline, during the procedure, immediately after procedure

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

  Baseline, 10 minutes after procedure

• Patient satisfaction

  Through study completion, an average of 1 week

• Provider satisfaction

  Through study completion, an average of 1 year

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

  Baseline, 5 minutes after procedure

Study Arms (3)

Virtual Reality Therapy (Intervention group 1)

EXPERIMENTAL

In 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.

Device: Virtual Reality system

Music Therapy (Intervention group 2)

EXPERIMENTAL

In 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.

Other: Headphones

Care as usual (control group/group 3)

NO INTERVENTION

The care as usual group (control group) will receive the care as usual. This group receives neither VRT nor MT during wound care.

Interventions

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.

Virtual Reality Therapy (Intervention group 1)

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.

Music Therapy (Intervention group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Surgical Wound; Wounds and Injuries

Study Officials

• Marlies Schijven, Prof. dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: February 24, 2023
• Study Start: November 17, 2022
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)