|- candidate number||14486|
|- NTR Number||NTR3889|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2013|
|- Secondary IDs||NL31227.029.11 CCMO|
|- Public Title||Effectiviteit van een operatie voor het behandelen van blozen en bloosangst.|
|- Scientific Title||The effects of Highly Selective Dorsal Sympathectomy on blushing and fear of blushing.|
|- ACRONYM||Effects of HSDS|
|- hypothesis||HDSD reduces blushing and fear of blushing. HDSD recudes social anxiety to a lesser extend. HDSD does not effect implicit measures.|
|- Healt Condition(s) or Problem(s) studied||Pathological blushing, Anxiety|
|- Inclusion criteria||Incapacitating facial blushing.|
|- Exclusion criteria||1. Being under 18;|
Furthermore, people are not allowed to undergo sympathetic surgery when they have:
2. A history of reconstructive chest wall surgery;
3. Pulmonary or (unsuccessful) sympathetic surgery including iatrogenic Harlequin syndrome;
4. Acceptable results with drug treatment;
5. ASA classification greater than 1.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2013|
|- planned closingdate||31-aug-2015|
|- Target number of participants||44|
|- Interventions||Bilateral HSDS is performed in a single operative setting. All procedures are performed by the same surgical team and a standard surgical protocol will be 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.|
|- Primary outcome||1. Fear of blushing subscale of the Blushing, Trembling and Sweating Questionaire (BTSQ; Bögels & Reith, 1999). This questionnaire assesses fear of showing somatic symptoms;|
2. Cheek coloration will be used to index blushing and will be recorded from a plethysmograph transducer fastened to the skin with tape for sensitive skin on the zygomatic bone near the inner canthus. As a second measure, cheek temperature will be monitored unilaterally with a semi-conductive thermistor fastened to the skin, just below the plethysmograph transducer. Blushing will be measured during a baseline rest period and during a social task;
3. Social anxiety will be measured with 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).
|- Secondary outcome||The subjects will complete the Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) and the nineteen-item version of the Blushing Propensity Scale (BPS; Bögels, Alberts & de Jong, 1996). Furthermore, implicit self-esteem will be assessed using an Implicit Association Test (Glashouwer, de Jong, Dijk & Buwalda, 2011); explicit self-esteem using the Rosenberg Self-Esteem scale (Rosenberg, 1965); interpretations about will be assessed with the Blush Cognitions Questionnaire (Dijk, et al., 2009) and with a recognition task (Dulken, van, 2010). The SCID-I/P (Spitzer et al., 1992) will be used as a diagnostic interview to examine the presence of psychopathology.|
|- Timepoints||Both groups will be measured three times:|
1. Before the opertation/waiting list period (SCID, Blushing, BTSQ, BPS, SIAS, BFNE, FQ, CED-D, IAT, Blush congnitions, Interpretation Bias);
2. After the operation/waiting list (same measurments as t1 but without SCID);
3. At a three months follow us (same measurents as t1 but without Blushing).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD. Corine Dijk|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Corine Dijk|
|- Sponsor/Initiator ||University of Amsterdam (UvA), VU University Medical Center|
(Source(s) of Monetary or Material Support)
|University of Amsterdam, VU University Medical Center|
|- Brief summary||Rationale: |
Examine the effectiveness of robot-assisted highly selective dorsal sympathectomy (HSDS) on the physiological blush response and social anxiety due to blushing. Despite its popularity, the effectiveness of this surgical intervention has never been tested in a randomized controlled trial and the methodological set up of most studies that tested the effectiveness of the intervention is poor.
The main aim of the study is to compare the effects of the intervention with a waiting list (WL) and examine the reduction in social anxiety, fear of blushing and the physiological blush response. A second aim is to test the effects of the treatment on depression and cognitive biases.
The study is a randomized clinical trial with two conditions (HSDS and WL) and three measurements (before treatment/WL period, after treatment/WL period and at a 3 months follow-up).
The study population consists of people who applied for HSDS at the VU medical centre (age>18).
The HSDS is a minimal invasive endoscopical procedure in which bilaterally the efferent rami communicantes of the thoracic sympathetic ganglion T2 to T4 are divided.
Main study parameters/endpoints:
The main study parameters are the reduction of social anxiety, fear of blushing and the actual physiological blush response.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All subjects are on the waiting list for HSDS, so the operation itself cannot be considered a risk of the study (the subjects will also undergo this treatment without participating in the study). Benefits are a possible shortening of the waiting period for HSDS
and the assessments may help subjects gain a better understanding of their complaints.
|- Main changes (audit trail)||Amendement: The effects of Highly Selective Dorsal Sympathectomy on blushing and fear of blushing - 1-8-2013
- The modification concerns omitting the physiological measures from the study.
- This measure is left out because results of pilot studies show that it is difficult to reliably measure the physiological blush in a repeated design. Since participants have to go to the VUmc in Amsterdam for this measure only (all other measures can be conducted via telephone or internet), this measure involves a huge burdening for the participants. We believe that at the moment the burden for the participants does not outweigh the reliability of the task.
|- RECORD||11-mrt-2013 - 1-aug-2013|