Wednesday, September 3, 2014

This Is An Intervention!

An interventional study (also referred to as a clinical trial) is an experiment that involves the researching of human volunteers, focusing on one common medical condition shared between the participants, to gain medical knowledge. These types of studies must always include participant consent that can be proven legally. By providing consent, participants state that they are willing to subject themselves to testing and agree to any ethical standing.

As an example of an interventional study, I will be researching and reviewing a study sponsored by University Hospital, Grenoble. This study focuses on assessing an innovative Visual Analog Scale (VAS) of pain among deaf people.  French literature shows that 80% of deaf people are illiterate, and only 1/3 of the words spoken through lip-reading are recognized. Pictorial VAS pain scales include the elements that can be identified and understood by the deaf community. These elements can include pictures or colors that can indicate the different levels of pain.

 The researchers searched for participants at several  hospitals, asking for volunteers to meet at the designated study locations.  Before the study began, the researchers advised the volunteer participants to consult their doctor, family, and friends before making the decision to participate. During the study, the participants were asked to represent their level of pain on the visual analog scale. Half of the participants were given a pictorial VAS while the other participants were given a regular VAS to portray their level of pain. Both groups were then asked to sign their level of pain in French Sign Language. The signings were then compared to what the patient indicated on the chart and checked for accuracy in meaning. The researchers of the study hypothesized that pictorial VAS was more suited to the deaf than usual VAS. The study tested 289 participants over the course of two years. 

 Below are examples of a pictorial VAS and a usual VAS.


Pictorial
(http://www.rcsed.ac.uk/RCSEDBackIssues/journal/vol44_3/4430012.gif)



Usual

(https://assets-production-webvanta-com.s3-us-west-2.amazonaws.com/000000/47/62/original/images/img_118_oregon_pain/visual_analog_scale.gif)


The participants of the study were selected based on the following criteria:

Inclusion Criteria
Must have signed consent form
Deaf People
Must be at least 18 years old
Affiliation to the French Social Security System or Equivalent

Exclusion Criteria
Hearing People
People Who Became Deaf
Pregnant/Breastfeeding Women
People Deprived of Freedom
People Hospitalized Without Consent



The study took place from July 22, 2011 to July 22, 2013. No results were ever posted for this study.



Direct information on this study can be referenced here:

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