The effect of audio-visual immersion on pain, anxiety and satisfaction in patients undergoing wrist-fracture reduction in the Emergency Department, a randomized controlled trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain perception is measured using the VAS. The VAS-P is an 11 point scale<br /><br>ranging up from 0 to 10. With 0 indicating no pain and 10 indicating the<br /><br>worst pain possible. Pain perception is measured at two intervals. The first<br /><br>measurement will be just before putting on the glasses, last one immediately<br /><br>after the procedure. During the last measurement the patients will be asked to<br /><br>grade the maximum pain score of the local anaesthetic placement an of the<br /><br>procedure (fracture reduction) that took place.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Anxiety is measured using the VAS-A, an 11 point scale. With 0 indicating no<br /><br>anxiety and 10 indicating severe anxiety.<br /><br><br /><br>Anxiety is measured prior to putting on the video glasses and immediately after<br /><br>taking the video glasses off.<br /><br><br /><br>The patient satisfaction VAS-S will be scored prior to patient discharge. The<br /><br>VAS for the measurement of satisfaction is an 11 point scale ranging up from 0<br /><br>to 10. With 0 indicating not satisfied at all with the total procedure and<br /><br>10 indicating completely satisfied with the total procedure.<br /><br><br /><br>The patient will also be asked to rate the quality of the audio and visual<br /><br>effects on an 11-point scale and if he/she would consider using the device<br /><br>again under similar circumstances.</p><br>