The primary objective of this study is to assess the effect of audio-visual immersion on pain perception in patients undergoing a short surgical procedure (a.i. wrist fracture reduction) under local anesthesia in the Emergency Department (ED).…
ID
Source
Brief title
Condition
- Other condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain perception is measured using the VAS. The VAS-P is an 11 point scale
ranging up from 0 to 10. With 0 indicating *no pain* and 10 indicating *the
worst pain possible*. Pain perception is measured at two intervals. The first
measurement will be just before putting on the glasses, last one immediately
after the procedure. During the last measurement the patients will be asked to
grade the maximum pain score of the local anaesthetic placement an of the
procedure (fracture reduction) that took place.
Secondary outcome
Anxiety is measured using the VAS-A, an 11 point scale. With 0 indicating *no
anxiety* and 10 indicating *severe anxiety*.
Anxiety is measured prior to putting on the video glasses and immediately after
taking the video glasses off.
The patient satisfaction VAS-S will be scored prior to patient discharge. The
VAS for the measurement of satisfaction is an 11 point scale ranging up from 0
to 10. With 0 indicating *not satisfied at all with the total procedure* and
10 indicating *completely satisfied with the total procedure*.
The patient will also be asked to rate the quality of the audio and visual
effects on an 11-point scale and if he/she would consider using the device
again under similar circumstances.
Background summary
Patients undergoing surgical procedures in the Emergency Department often
experience pain and anxiety. These procedures include reduction of fractures
and reduction of dislocated joints. To ensure the comfort of these patients
pharmacological options a.i. local anesthesia, analgesic medication and
sedatives are usually given. However with pharmacological intervention there is
always a risk of side effects and potential adverse events.
Distraction is an old technique that appears to be safe, inexpensive and
effective in reducing anxiety and pain in short painful procedures.
Recently this has been re-introduced by means of high-tech audio and visual
applications for patients undergoing surgical procedures.
With this study we specifically evaluate the effect of distraction by
audiovisual immersion in patients who receive a local anesthetic and reduction
of a broken wrist in the Emergency Department.
Study objective
The primary objective of this study is to assess the effect of audio-visual
immersion on pain perception in patients undergoing a short surgical procedure
(a.i. wrist fracture reduction) under local anesthesia in the Emergency
Department (ED). Furthermore, we aim to assess the effect of audio-visual
immersion on anxiety and patient satisfaction.
Study design
Randomized controlled trial with 2 groups.
Intervention
The intervention group will be provided with the audiovisual headset device as
soon as the patient is placed in the room where the procedure will take place.
The device will be worn during the placement of the local anaesthetic and
continued to be worn during the short surgical procedure. At all times the
device can be removed if the patient feels uncomfortable or if the treating
physician deems it necessary.
Study burden and risks
Benefits for the patients
During the clinical intervention, we anticipate a potential benefit for the
patients as they will be distracted from any unpleasant anxiety and/or pain
inducing visual and audible inputs (a.i. needles (local anesthesia),
counterweights and manipulation). It is anticipated that the patient may need
less sedatives and/or analgesic medication. This may in turn lead to less side
effects/ adverse events. We will also monitor first time success rate of the
procedure, as this may increase when the patient is more relaxed. The
subjective treatment time may be perceived as being reduced to actual time.
All together this may result in improved patient satisfaction scores.
Benefits for the hospital
Gentle and non-pharmaceutical distraction of the patient may support ease of
procedure and success rate of the procedure. This may in turn facilitate faster
throughput times in the ED. It may also economize the use of sedatives and pain
medication
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
- Dislocated wrist fracture with an indication for repositioning in the ED
under local anaesthesia with lidocaine
- Age >18 years old
Exclusion criteria
* Individuals not being able to understand Dutch language at primary school
level
* Individuals not being able to read or write Dutch
* Individuals who are unable to sign informed consent owing to
mental/psychiatric disorder or formally stated to be incompetent to decide
* Individuals not willing or able to sign informed consent for the proposed
study
* Individuals with a history of loss of central or peripheral field of vision
on either eye
* Individuals with a history of either conductive, sensorineural or mixed
hearing loss
* Individuals wearing hearing devices on either ear
* Individuals with a known history of anxiety disorder
* Individuals with an alcohol, drug dependency problem or intoxication
* Individuals using chronic opioid pain medication
* Individuals with a fracture or dislocated joint that requires immediate
surgery in the operating theatre or a fracture which is > 24 hours old
* Individuals with a known allergy or other contra-indication for the use of
lidocaine
* Individuals with a multi-trauma (excluding superficial wounds and minor
contusions)
* Second reduction attempt (after cast immobilization) of same fracture
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67837.018.18 |
| OMON | NL-OMON20686 |