The main objectives of this study are to investigate to what extent:1) VRT and MT can contribute to pain reduction compared to patients who receive no VRT and MT intervention during complex wound care; and2) VRT can contribute to pain reduction…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain score measured with the VAS-score
Secondary outcome
- Level of anxiety, measured with the STAI-6 questionnaire
- Length of hospital stay
- Patient and provider satisfaction, measured with questionnaires
- Blood pressure
- Heart rate
- Saturation
- Respiratory rate
Background summary
Wound-related pain is common and is usually experienced as both physically and
emotionally unpleasant. Pain can cause stress which can negatively affect wound
healing and the patient's quality of life. Opioids are mostly used for pain
management. However, opioids have side effects, risk of dose tolerance and risk
of drugs dependence. Therefore, it is important to be able to offer patients
effective alternatives, such as non-pharmacological pain relief through
distraction. Virtual Reality therapy and Music therapy are one of these
non-pharmacological interventions. Previous research has shown that Virtual
Reality therapy and Music therapy have a positive effect on pain, anxiety and
opioid use.
This study investigates the extent to which Virtual Reality glasses and Music
therapy can contribute to less pain, and less anxiety compared to patients who
receive no intervention during complex wound care. And to investigate to what
extent VRT can contribute to pain reduction compared to patients receiving MT.
In addition, it is examined which of the two interventions is preferable.
Study objective
The main objectives of this study are to investigate to what extent:
1) VRT and MT can contribute to pain reduction compared to patients who receive
no VRT and MT intervention during complex wound care; and
2) VRT can contribute to pain reduction compared to patients receiving MT
In addition, it is examined which of the two interventions is preferable.
Study design
Randomized Clinical Trial
After the patient has decided to participate in the study, it is randomly
determined to which group the patient belongs:
- Group 1 (intervention group 1): The intervention group 1 wears Virtual
Reality glasses during the wound care moment, where they can choose from a
number of themes. This group wears the Virtual Reality glasses 10 minutes
before the start of the wound care, until 1 minute after the wound care has
ended.
- Group 2 (intervention group 2): The intervention group 2 wears a headphone
with music, where they can choose their own music. 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.
- Group 3 (control group): The control group receives neither Virtual Reality
glasses nor Music Therapy during wound care.
Patients who have experienced at least 1 wound care moment, where they have
indicated a VAS equal to 4 or higher, can participate in the study. After they
have decided to participate, they are examined during 1 to 3 wound care moments.
Before and after the wound care moment, both groups are asked to indicate the
pain score according to the VAS score, to complete the validated questionnaire
about anxiety (STAI-6) and the satisfaction questionnaire.
During the wound care moment, the mean heart rate, blood pressure, respiratory
rate and saturation are recorded for both groups.
Patients are prescribed the basic pain medication according to the WHO pain
ladder as standard: paracetamol and/or NSAIDs. At the request of the patient,
patients can receive escape pain medication.
Intervention
Group 1 (intervention group 1): The intervention group 1 wears Virtual Reality
glasses during the wound care moment, where they can choose from a number of
themes. This group wears the Virtual Reality glasses 10 minutes before the
start of the wound care, until 1 minute after the wound care has ended.
Group 2 (intervention group 2): The intervention group 2 wears a headphone with
music, where they can choose their own music. 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.
Group 3 (control group): The control group receives neither Virtual Reality
glasses nor Music Therapy during wound care.
Study burden and risks
Patients who decide to participate in the study will be asked to indicate their
pain score (VAS) before and after wound care, and asked to complete
questionnaires investigating anxiety (STAI-6) and satisfaction (patient
satisfaction questionnaire). Blood pressure, heart rate, saturation and
respiratory rate are measured 5 minutes before wound care. During wound care,
heart rate, satiety and respiration are measured every 5 minutes. These vital
signs are measured again 5 minutes after wound care has ended. In total, a
minimum of 1 to a maximum of 3 wound care procedures will be included in the
study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Individuals aged 18 or older having wounds receiving wound care
- Individuals who will undergo minimum of 1 to a maximum of 3 sequential
complex wound care* procedures
- 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.
*Complex wound care: Wound care deemed fit for conservative wound care (based
on wound properties, such as: cause, location, size, the necessary
intervention), including necrosectomy at the hospital ward as per regular wound
care protocol
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
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL82062.018.22 |