To assess whether the use of Virtual Reality Therapy can reduce pain, and anxiety than without Virtual Reality Therapy in patients undergoing complex wound care procedures.
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 STAl-6 questionnaire
- Length of hospital stay
- Patient and provider satisfaction, measured with questionnaires
- Blood pressure
- Heart rate
- Saturation
- Respiratory rate
Background summary
Pain is the most common clinical symptom of tissue damage. Wound-related pain
is usually experienced as physically and emotionally unpleasant and is unique
to each individual, which can cause stress and lead to adverse effects on wound
healing and the patient's anxiety. Therefore, adequate pain and anxiety
management during wound care is important. The use of (more) pain medication,
such as opioids, has side effects. It is therefore important to be able to
offer patients effective alternatives.
Virtual Reality system generate an immersive virtual environment, which can
lead to audiovisual distractions.
This research addresses the potential benefits of use of the Virtual Reality
system in terms of pain reduction, and reduction of anxiety, during complex
wound care procedures.
Study objective
To assess whether the use of Virtual Reality Therapy can reduce pain, and
anxiety than without Virtual Reality Therapy in patients undergoing complex
wound care procedures.
Study design
Randomized Clinical Trial.
Alter the patient has decided to participate in the study, it is randomly
determined to which group the patient belongs:
- Group 1 (lntervention group 1 ): The intervention group 1 wears the Virtual
Reality system (glasses + headphone) during the wound care moment, where they
can choose from a number of themes/videos. This group wears the Virtual Reality
system 10 minutes before the start of the wound care, until 1 minute after the
wound care has ended.
- Group 2 (control group): The control group receives no Virtual Reality
Therapy.
Patients who have experienced at least 1 wound care moment, where they have
indicated a VAS equal to 4 or higher, or patients reporting a VAS >= 4 before
initiating the wound care procedure, can participate in the study. After they
have decided to participate, they are examined during 1 to 3 wound care
moments.
Before and alter 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 (STAl-6) and the satisfaction questionnaire. A maximum of 7
questionnaires will be administered in total.
.
Heart rate, respiratory rate and saturation are measured every 5 minutes during
wound care in both groups (intervention- and control group). Blood pressure,
heart rate, respiratory rate and saturation are also measured 5 minutes before,
and 5 minutes after the wound care procedure.
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
system during the wound care moment, where they can choose from a number of
themes. This group wears the Virtual Reality system 10 minutes before the start
of the wound care, until 1 minute alter the wound care has ended.
Group 2 (control group): The control group receives no Virtual Reality Therapy
during wound care.
Study burden and risks
All 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
questionnaire investigating anxiety (STAl-6). In both groups, blood pressure,
heart rate, saturation and respiratory rate are measured 5 minutes before wound
care. During wound care, heart rate, saturation and respiration rate 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. After the third wound care procedure
all participants are requested to fill out the patient satisfaction
questionnaire. A maximum of 7 questionnaires will be administered in total.
In total, this study will take approximately 180 minutes.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Individuals aged 18 or older with wounds receiving wound care
- lndividuals who will undergo minimum of 1 to 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
- lndividuals not being able to understand Dutch language at primary school
level
- lndividuals not being able to read or write Dutch
- lndividuals diagnosed with dementia and/or cognitive impairment
- lndividuals diagnosed with epilepsy
- lndividuals diagnosed with migraine
- lndividuals with severe dizziness and/or nausea
- lndividuals with a known history of claustrophobia
- lndividuals who are unable to sign informed consent owing to mental disorder
or formally stated to be incompetent to decide
- lndividuals who have no feeling in the wound care area
- lndividuals 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82360.029.22 |