The first aim is to test the effect of the surgical intervention for fear of blushing in a randomized controlled trail consisting of a robot-assisted highly selective dorsal sympathectomy and a waiting list control group. There are several outcome…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fear of blushing subscale of the Blushing, Trembling and Sweating Questionnaire
(BTSQ; Bögels & Reith, 1999). This questionnaire assesses fear of showing
somatic symptoms.
Secondary outcome
Daily blushing will be measured with the use of visual analogue scales.
For a comprehensive description of the sample, the subjects will complete the
Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977); the
Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998); the brief Fear
of Negative Evaluation Scale (BFNE; Leary, 1983); the social phobia subscale of
the Fear Questionnaire (FQ; Marks and Mathews, 1979); and the nineteen-item
version of the Blushing Propensity Scale (BPS; Bögels, Alberts & de Jong, 1996)
.
Implicit blush associations will be assessed using a Implicit Association Test
(Glashouwer, de Jong, Dijk & Buwalda, 2010); interpretations using the Blush
Cognitions Questionnaire (Dijk, et al., 2009) and a recognition task (Dulken,
2010) . The SCID-I-I/P (Spitzer et al., 1992) will be used as a diagnostic
interview to examine psychopathology.
Background summary
Fear of blushing is a disabling disorder. People who fear their blushes do so
in many social situations and consequently avoid those situations or endure
them with intense fears. Although several psychological interventions are
available and effective, the clinical impression is that people with fear of
blushing do not seek professional help easily and when they do, their fear is
often not well recognised. Furthermore, people with fear of blushing often see
their complaint as mainly physiological instead of psychological, which may
explain the popularity of an operation to remove the ability to blush
altogether by means of the surgical cutting through of the sympathetic nerve.
Despite its popularity, the effectiveness of this surgical intervention has
never been tested in a randomized controlled trial and the methodological
design of most studies that tested the effectiveness of the intervention is
poor. Furthermore, only few studies actually measure if the operation reduced
anxiety complaints but none of them actually measured fear of blushing. The
current study is set up to fill this gap in the literature.
Study objective
The first aim is to test the effect of the surgical intervention for fear of
blushing in a randomized controlled trail consisting of a robot-assisted highly
selective dorsal sympathectomy and a waiting list control group.
There are several outcome measures to test the effectiveness of the
intervention. Fear of blushing and social fears will be measured using standard
scales. Blush intensity will be measured subjectively using visual analogue
scales.
Also, the effect the intervention on several information processing and
cognitive biases will be tested, since these are known to play a key role in
maintaining fears. That is, beliefs about blushing, implicit associations and
interpretation biases will be measured.
Furthermore, all subjects will receive a diagnostic interview to asses their
psychopathology both before and after treatment.
Study design
The design is quasi experimental: only people who already applied for the
operation will be included in the study. Within this group of people, the study
is a randomized controlled trail consisting of two arms: sympathectomy (HSDS)
and a waiting list (WL). The duration of the study is 20 weeks and the study is
being conducted at the VU medical centre (HSDS) and the Psypoli of the UvA
(diagnostics). There are three moments of measurement: before the
intervention/waiting time (t1), right after the intervention/waiting time (t2)
and a 3 month follow up (t3).
Intervention
Operative technique
Bilateral HSDS is performed in a single operative setting. All procedures are
performed by the same surgical team and a standard surgical protocol was
followed throughout the study period. General anaesthesia using single-lumen
tube endotracheal intubation and low volume-high frequency ventilation is
applied in all patients. Patients are placed in a lateral decubitus position.
Three thoracoscopic ports, one of 13-mm diameter situated in the 6th
intercostal space at the mid axillary line and two 8-mm ports in the 4th
intercostal space, 5 cm anterior, and 5 cm more posterior to the mid axillary
line, respectively. The Da Vinci robot (Intuitive Surgical, Inc. Sunnyvale, CA,
USA) is positioned near the head of the patient. All patients undergo HSDS by
division of their rami communicantes efferentes grisei from the T2 ganglion to
the T4 ganglion using robotic manipulation, a 30° 3-D thoracoscope and bipolar
electrocautery. The mediastinal pleura is opened and the anatomy of the whole
upper part of the sympathetic chain and its rami communicantes are identified.
The main trunk is mobilised and preserved and the efferent rami communicantes
from T2 to T4 are interrupted and removed 2 cm laterally in all patients. If
present, accessory fibres and Kuntz*s nerve are coagulated. A chest tube of 16
French is inserted to be removed the next day. The robot is retracted at
closure and the patient is turned on the contra lateral side for an identical
procedure. The total operating time is 60 minutes, hospital stay 2 days.
Study burden and risks
The measurements are time consuming but there are no risks involved. All
subjects are on the waiting list for HSDS, so the operation itself cannot be
considered a risk of the study (since subjects will also undergo this treatment
without participating in the study). Nevertheless, the benefits of the Highly
Selective Dorsal sympathectomy (HSDS) include the immediate disappearance of
blushing and, possibly, blushing anxiety. The risks include the introduction of
compensatory sweating (35% of the cases), Horner Syndrome (2.5% of the cases),
postoperative pain (5 % of the cases) and pneumothorax (5% of the cases).
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Incapacitating facial blushing.
Exclusion criteria
Being under 18. Furthermore, people are not allowed to undergo sympathetic surgery when they have: 1) A history of reconstructive chest wall surgery; 2) Pulmonary or (unsuccessful) sympathetic surgery including iatrogenic Harlequin syndrome; 3) Acceptable results with drug treatment; 4) ASA classification greater than 1.
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 | NL31227.029.11 |