Karen says:
> A nurse colleague of mine is currently preparing a study
> for her Masters
> looking at the use of relaxation post breast surgery. She
> has done all the
> necessary lit searches and has found some randomised
> trials, but none
> blinded. Her Prof is keen for her to blind this study but
> there are many difficulties.
There certainly are. I can't imagine a study in which
the subjects were "blind" with respect to the treatment
they received. It's an oxymoron. There are very few
places on earth where patients don't already know what
"relaxation training" is.
However, she could still have blind evaluations pre and
post treatment. That simply means the rater did not
know the treatment (or control) condition to which
the subject was assigned.
Even more difficult is establishing appropriate
controls. This happens all the time in pelvic muscle
rehabilitation research using biofeedback. Proper
application of biofeedback requires intensive,
personalized intervention/training. It is difficult
to find a comparable intervention (in terms of
therapist contact hours, etc.) that would meet the
usual definitions of placebo.
This is certainly the case in relaxation. Virtually
anything the patient does for 20 minutes twice a day
(read a book, watch a videotape travelogue, etc.)
is going to have "relaxation" effects similar to
the relaxation training. (See Benson, The Relaxation
Response, 1975.) If the relaxation techniques
are truly robust, they might prove statistically
better than reading a book. (But if not, it would
be cheaper to just give them library cards!<g>)
But what is the purpose of the study? Is there some
hypothesis that relaxation should result in some
benefit or improvement in the patient post surgery?
What is that benefit? How is it objectively measured?
How long does it last?
If relaxation doesn't result in some objective change
in the patients (faster recovery, etc.) then why do it?
> We are currently scratching our heads a bit...anyone aware of any
> individual/team who has attempted a blinded relaxation study OR any
> literature we may have missed using Medline?
> Thanks in advance
> Karen (research physio)
Have you looked at literature in the biofeedback
field? There is an abundance of evidence that
"Criterion-referenced Biofeedback" (usually
defined as ability to reach 96 degrees F finger
temperature in less than 20 minutes) is far
superior to the traditional guided imagery,
meditation, yoga, and other verbal methods.
Relaxation is a skill that is acquired by training.
It is not a drug that works without the patient's
knowledge or awareness. Blindness is used to
eliminate patient variables when testing the
efficacy of a drug. But patient variables are
precisely what is being trained in relaxation
training. So you can't compare training vs. no
training; you can compare one method vs.
another method. Still subjects can't be blind.
(Just "in the dark"!<g>)
I have an article "Is electrical stimulation a drug?
Is biofeedback a drug? Is electric stimulation a
behavioral therapy?" that will appear in the March
2000 issue of Biofeedback newsmagazine; I'll be
happy to send you a copy after it appears. It
discusses these issues in detail.
Best wishes,
John Perry
John D. Perry, PhD, MDiv, BCIA, FAACS
1192 Lakeville Circle
Petaluma, CA 94954
Telephone: 707-789-9135
Facsimile: 707-789-9137
Mailto:[log in to unmask]
http://www.InContiNet.com (email list: [log in to unmask])
http://www.DrGSpot.net (email list: [log in to unmask])
"If I'd known I was going to live this long,
I'd have taken better care of my body!"
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