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Trial design | RECRUITMENT | This study was a prospective, single-centre, single-arm trial and investigated facial expressions before (T0) and 4 months after orthognathic surgery (T1). It was approved by the institutional ethics committee (application number 13/2/19) in accordance with the Declaration of Helsinki. All participants gave written inf... | PMC10560183 | |
Participants, eligibility criteria, and settings | malocclusion | Patients seeking orthodontic-surgical treatment with an orthodontics first approach at the Department of Orthodontics, University Medical Center Goettingen, Germany, were enrolled consecutively. The eligibility criteria for participants were adults over 18 years old, orthodontic therapy with fixed appliance, pronounced... | PMC10560183 | |
Sample size | RECRUITMENT | As this trial is an early clinical trial with the aim to implement the novel method of 4D videostereophotogrammetry, sample size calculation was not based on a priori-hypothesis testing. Based on previous treatment numbers, in total 45 patients (1 skeletal class I, 21 skeletal class II, 23 skeletal class III) were oper... | PMC10560183 | |
Intervention | All patients underwent virtually planned, splint-based orthognathic surgery performed by an interdisciplinary team of orthodontists and maxillofacial surgeons as described previously [ | PMC10560183 | ||
Blinding | Blinding was not applicable. | PMC10560183 | ||
Outcome—facial expressions | Facial expressions were recorded as 3D videos using non-invasive 4D stereophotogrammetry with nine cameras (6 greyscaled and 3 coloured) and 60 frames per seconds (see Fig. Motion capture system recording facial expressions as 3D videos using non-invasive 4D stereophotogrammetry with nine cameras (6 greyscaled and 3 co... | PMC10560183 | ||
Method error analysis | To assess the reliability of the 4D tracking of facial expressions, the same investigator repeated the application of the dummy mesh to the individual patients’ morphology in ten cases. Additionally, a second examiner performed the same task one time. Agreement was excellent for the magnitude of facial expression (ICC ... | PMC10560183 | ||
Statistical analysis | The analysis was performed using linear mixed-effects models with factors time, skeletal class, and their interaction. A sensitivity analysis using a paired Wilcoxon-signed rank test was performed. Estimated marginal means are reported with 95% confidence interval and compared between time and skeletal class [ | PMC10560183 | ||
Results | PMC10560183 | |||
4D motion capture | 4D motion capture was feasible using stereophotogrammetry and resulted in 3D videos with a rate of 60 frames per second. Colour and texture were recorded as well as surface geometry (see Supplementary Information | PMC10560183 | ||
Facial expressions | For maximum smile the mean magnitude of movement increased significantly from T0 until T1 by 2 mm. At T1, smiling became more asymmetric. No differences in shape change or time was observed. The mean magnitude of lip purse decreased from T0 until T1 by 1 mm. Shape change, symmetry, and time for the facial expression di... | PMC10560183 | ||
Harms | No harms were observed. | PMC10560183 | ||
Discussion | PMC10560183 | |||
Main findings in context of the existing evidence—method | The main strength of this study was the implementation of modern videostereophotogrammetry in orthodontics and its use to capture facial movements in 4D. In contrast to previous attempts analysing facial expressions using markers on the patients’ face [A current disadvantage of videostereophotogrammetry is that the nec... | PMC10560183 | ||
Main findings in context of the existing evidence—results | The main finding was that orthodontic-surgical treatment increases the magnitude of the facial expression maximum smile by approximately 13% (= 2 mm), while it decreases that of the facial expression lip purse by approximately 11% (= 1 mm). The parameters shape change, time, and symmetry of the movement demonstrated no... | PMC10560183 | ||
Limitations | The participants of the study were not operated on by the same surgeon, but all surgeries were performed at a single centre following the same stringent protocol. Since a multi-centre study revealed that even different surgeons at different centres obtain similar accuracy when following a virtual treatment plan [It is ... | PMC10560183 | ||
Generalisability | The results of this trial were from a single specialist clinic in Germany, which might reduce the applicability to other clinical settings. However, the eligibility criteria include most patients undergoing orthodontic-surgical treatment and the followed surgery protocol is widely used and well established.This study d... | PMC10560183 | ||
Further research | swelling, orthodontic, malocclusions | RECRUITMENT | The focus of this study was the integration of videostereophotogrammetry in orthodontic-surgical treatment. To fully understand the effect of orthodontic-surgical treatment on facial expressions, long-term observations and extended study periods are needed. Baseline assessment was performed after orthodontic decompensa... | PMC10560183 |
Conclusions | The present study implemented the novel approach of 4D motion capture using videostereophotogrammetry in orthodontic research. Within the limitations of this clinical trial, the following conclusion can be made:Implementation of videostereophotogrammetry in orthodontic-surgical treatment is feasible and allows the eval... | PMC10560183 | ||
Author contributions | A.Q., M.S., H.S. and P.M.M. contributed to study conception and design. A.Q., J.H. and P.K. recruited participants and collected the data. J.H. performed the 4D tracking. J.M. wrote the code for data analysis. A.Q., T.A. and C.D. analyzed and interpreted the data. A.Q. and P.M.M. drafted the manuscript. All authors cri... | PMC10560183 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. This work was supported by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)—427616114—and by the Deutsche Gesellschaft für Kieferorthopädie (DGKFO, German Orthodontic Society). | PMC10560183 | ||
Data Availability | The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. | PMC10560183 | ||
Declarations | PMC10560183 | |||
Competing interests | The authors declare no competing interests. | PMC10560183 | ||
Ethical approval | This study was approved by the institutional ethics committee (application number 13/2/19) in accordance with the Declaration of Helsinki. | PMC10560183 | ||
Conflict of interest | The authors declare no competing interests. | PMC10560183 | ||
References | PMC10560183 | |||
Participants | Cushing’s or Addison, eating disorder | DISEASE | In this study, non-athletes were defined as individuals who did not currently
engage in any form of sport at any level of competition (e.g., recreational or
intramural sports). Varsity athletes were defined as members of a university
competitive club or varsity team (competing at the provincial or national
level). Athl... | PMC9947689 |
Measures | PMC9947689 | |||
Demographic Questionnaire | hepatitis B | HEPATITIS B, STRESSFUL EVENTS | The demographic questionnaire screened participants for factors that could
influence cortisol (e.g., antidepressant medication, hepatitis B) and was
used to collect self-reported information, such as age, major, year of
study, ethnicity, sexual orientation, and varsity/club sport (if
applicable). Participants were scre... | PMC9947689 |
Trait Questionnaires | The International Physical Activity Questionnaire-Short (The Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4;
The Male Body Attitude Scale (MBAS; | PMC9947689 | ||
State Body Shame Questionnaire | The shame subscale of the Weight and Body-Related Shame and Guilt Scale
(WBRSG-BS; | PMC9947689 | ||
Manipulation Checks | PMC9947689 | |||
Previous Anthropometric Experience | Participants were asked if they had any of the anthropometric or strength
measurements taken previously. This measure was used to see if previously
having undergone these measures could potentially explain any blunted
responses observed. | PMC9947689 | ||
Perceptions of Confederates | Participants in the high-threat condition were asked to rate how attractive
they thought the female research confederate was and how similar the male
confederate was to their muscular ideal. Participants rated the female
confederate ranging from 0 = | PMC9947689 | ||
Procedure | BROCK, RECRUITMENT | Upon receiving ethics clearance from Brock University’s research ethics board
(REB# 17-083), participants were recruited via classroom and sport team meeting
announcements, and through a participant recruitment site run by the
university’s psychology department. Prospective participants were told the study
investigated... | PMC9947689 | |
High-Threat Condition | The principal researcher (male), a research assistant (female), and two
confederates were present in the high-threat condition only. The male
confederate (described as a second participant) represented the male ideal
(muscular build, well-defined abdominals, strong arms, and a “V” shaped
figure; Once changed into their... | PMC9947689 | ||
Low-Threat Condition | Testing in the low-threat condition was performed in the same laboratory as
the high-threat condition; however, all of the testing was performed away
from the mirrored walls. Only the principal researcher and one research
assistant were present. Following screening, participants were asked to
change into their shorts a... | PMC9947689 | ||
Salivary Collection Procedures and Cortisol Assay Determinants | Saliva was collected using Salivettes (Sarstedt). Participants were instructed to
accumulate as much saliva in their mouths as possible. They were then told to
remove the cap off the plastic tube and place the swab in their mouth without
using their hands, hold it in their mouth for 1 min, gently moving saliva toward
i... | PMC9947689 | ||
Results | Two univariate outliers for physical activity levels were identified, and these
values were winsorized ( | PMC9947689 | ||
Descriptive Statistics and Manipulation Checks | Athletes and non-athletes differed significantly on height
(Athletes (Means and standard deviations for the dependent variables at each time point, by
condition and athletic status, were calculated ( | PMC9947689 | ||
State Body Shame | A three-way (athlete status, condition, and time) mixed RM ANOVA was produced.
There was no significant three-way interaction ( | PMC9947689 | ||
Salivary Cortisol | A three-way (athlete status, condition, and time) mixed RM ANCOVA was produced,
with baseline salivary cortisol as the covariate. There was no significant
three-way interaction ( | PMC9947689 | ||
Discussion | ’ | The overall purpose of the current study was to examine psychobiological responses to
(i.e., state body shame and salivary cortisol), and recovery from, a
social-evaluative body image threat in young men and whether those responses
differed by athlete status. It was first hypothesized there would be significant
increas... | PMC9947689 | |
Athletes Versus Non-Athletes | Contrary to both body image (This is the first study to examine body shame responses in athletes versus
non-athletes (Second, the varsity athletes in the current study were at a lower competitive
level (e.g., interuniversity) compared with previous studies that examined more
elite level athletes (e.g., national enduran... | PMC9947689 | ||
Implications | ’ | The current study provides a number of important implications for future body
image and SSPT research. First, it offers further support for the idea that male
athletes and non-athletes experience meaningful and impactful body image
concerns comparable to women (Within the context of SSPT, this study provides further ev... | PMC9947689 | |
References | PMC9947689 | |||
Introduction | BDD, third-wave, depressive, psychiatric, BDD behaviors, Shame, binge eating disorder, depression, dysmorphic disorder | DISORDER | Shame is considered central in body dysmorphic disorder (BDD) and empirical
accounts highlight the link between shame and BDD symptoms as well as common
negative psychosocial effects of the disorder, yet there is a lack of
interventions addressing shame in this context. In the past decade, Acceptance
and commitment the... | PMC10150257 |
Method | PMC10150257 | |||
Study Design | SECONDARY | To investigate the effectiveness of the intervention for reducing body shame,
self-criticism, and BDD-behaviors, a randomized, nonconcurrent, multiple
baseline across participants design was used (Following enrollment, participants were randomized to baseline assessment phases
of different lengths, between 2 and 6 week... | PMC10150257 | |
Primary outcomes | self-criticism | The primary outcome measure was the daily self-monitoring of BDD-related
behaviors and the level of body shame and self-criticism experienced. Before
baseline, the concepts of BDD-behaviors, shame, and self-criticism were
explained and participants were shown how to fill out the daily
assessment. | PMC10150257 | |
Daily time spent on BDD-behaviors | BDD-related behaviors, avoidance behaviors | The daily record sheet asked participants to record the time spent on
BDD-related behaviors, categorized in checking, comparing, camouflaging,
and avoidance behaviors (e.g., “Number of minutes spent on
camouflaging”). The sum of each participants’ daily BDD-behaviors is
presented in the results section. | PMC10150257 | |
Daily ratings of body shame and self-criticism | Along with the BDD-behaviors, participants were asked to rate their
degree of (1) body shame (“On a 0–10 scale, where 0 = no shame at all,
and 10 = the most shame ever, to what extent have you felt ashamed
because of your appearance today?”) and (2) self-criticism (“On a 0–10
scale, where 0 = not self-critical at all, ... | PMC10150257 | ||
Secondary outcomes | PMC10150257 | |||
BDD symptoms | The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS;
| PMC10150257 | ||
General shame | The Internalized Shame Scale (ISS; | PMC10150257 | ||
Self-compassion and self-criticism | Self-compassion was measured with the 12-item Self-Compassion Scale-Short
Form (SCS-SF; | PMC10150257 | ||
Depression | Depression, MADRS-S | The Montgomery-Åsberg Depression Rating Scale (MADRS-S; | PMC10150257 | |
Quality of life | The Quality of Life Inventory (QOLI; | PMC10150257 | ||
Psychological flexibility | Dysmorphic Disorder | The Body Dysmorphic Disorder Acceptance and Action Questionnaire
(BDD-AAQ) is an investigator created 12-item measure of willingness to
accept undesirable thoughts and feelings associated with one’s
appearance, while acting in a way that is congruent with values and
goals. All items are reverse scored and are summed to... | PMC10150257 | |
Cognitive fusion | The Cognitive Fusion Questionnaire–7 (CFQ; | PMC10150257 | ||
Treatment credibility | Credibility/Expectancy Questionnaire (CEQ; | PMC10150257 | ||
Treatment satisfaction | Treatment satisfaction was assessed with Client Satisfaction
Questionnaire (CSQ-8; | PMC10150257 | ||
Intervention | compassion-focused | The treatment, ACTwC, was designed to target shame and self-criticism and
increase self-compassion, psychological flexibility, and quality of life in
patients suffering from BDD. A manual to guide each treatment session was
developed based on integrating research on BDD with theory and techniques from
ACT and compassio... | PMC10150257 | |
Data Analysis | Data analyses were conducted according to established guidelines for single-case
experimental designs, with visual inspection of plotted data as the primary
method (For the standardized outcome measures, 95% confidence intervals (CIs) were
calculated for each participant’s change scores to evaluate the reliability of
t... | PMC10150257 | ||
Results | PMC10150257 | |||
Shame | The daily records of body shame showed large fluctuations from day-to-day during
all phases, including baseline phase (At intake, global shame measured by the ISS, was in the range of moderate to
severe shame severity for all participants ( | PMC10150257 | ||
Depression | depression | At pretreatment, all of the participants had scores on the MADRS-S indicating
moderate to severe depression ( | PMC10150257 | |
Quality of Life | Before treatment, all participants reported low or extremely low quality of life,
based on the QOLI ( | PMC10150257 | ||
Process measures | See | PMC10150257 | ||
Self-Compassion | eating disorders | At intake, all participants had scores on the SCS-SF, measuring self-compassion,
comparable or lower than previously published means for a clinical sample with
eating disorders ( | PMC10150257 | |
Psychological Flexibility | All participants reported improvements in psychological flexibility measured by
the BDD-AAQ, with gains ranging from 28% to 188% posttreatment. Cognitive
fusion, measured by the CFQ-7, reliably decreased (with 41%–60%) for P1, P2, and
P5 during treatment. For P4, scores were unchanged at posttreatment but had
significa... | PMC10150257 | ||
Treatment Credibility and Acceptability | After psychoeducation phase, all participants rated ACTwC for BDD as credible
(According to the CSQ-8, the four treatment responders were very satisfied with
the treatment they received, whereas the non-responder reported he was
indifferent or somewhat displeased. Furthermore, all treatment responders found
treatment q... | PMC10150257 | ||
Discussion | depressive, depression, psychiatric, self-criticism | SECONDARY, REMISSION | This study used a controlled multiple baseline design methodology to evaluate a
12-session acceptance and compassion-based intervention targeting shame in BDD. Our
first aim, to investigate preliminary effectiveness of ACTwC for BDD, was supported.
The intervention led to large improvements in BDD-behaviors and self-cr... | PMC10150257 |
Conclusions | depressive mood | In conclusion, the results from this pilot study suggest that ACT with Compassion has
potential to reduce BDD symptoms, shame, and self-criticism, and in addition,
improve depressive mood and patients’ quality of life. Also, the treatment was
considered acceptable to the patients. Feedback and study results will be use... | PMC10150257 | |
Supplemental Material | PMC10150257 | |||
sj-docx-1-bmo-10.1177_01454455221129989 – Supplemental material for
Acceptance and Compassion-Based Therapy Targeting Shame in Body Dysmorphic
Disorder: A Multiple Baseline Study | Dysmorphic Disorder | Click here for additional data file.Supplemental material, sj-docx-1-bmo-10.1177_01454455221129989 for Acceptance and
Compassion-Based Therapy Targeting Shame in Body Dysmorphic Disorder: A Multiple
Baseline Study by Johanna Linde, Jason B. Luoma, Christian Rück, Jonas Ramnerö
and Tobias Lundgren in Behavior Modificati... | PMC10150257 | |
References | PMC10150257 | |||
Background | DCIS, DUCTAL CARCINOMA IN SITU, RECRUITMENT, RECRUITMENT | The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centr... | PMC10576350 | |
Methods | anxiety | DCIS, RECRUITMENT | Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participati... | PMC10576350 |
Results | anxiety | SAID, RECRUITMENT | Eighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the trial offered the best treatment, whilst worries about randomisation and th... | PMC10576350 |
Conclusions | RECRUITMENT, RECRUITMENT | Recruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the study could improve recruitment in similar future trials. | PMC10576350 | |
Trial registration | MAY | ISRCTN27544579, prospectively registered on 22 May 2014 | PMC10576350 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07703-4. | PMC10576350 | ||
Keywords | PMC10576350 | |||
Background | cancers | DCIS, CANCERS, DUCTAL CARCINOMA IN SITU | Ductal carcinoma in situ (DCIS) is a condition in which neoplastic breast cells are confined to the lining of breast ducts. It is classified into three histological grades—high, intermediate, and low—according to cyto-nuclear feature [In 2012, an independent panel reviewed the evidence on benefits and harms of screenin... | PMC10576350 |
Methods | DCIS, DUCTAL CARCINOMA IN SITU | The LORIS study is a multi-centre, phase III RCT of surgery versus active monitoring with annual mammography in patients with low-risk ductal carcinoma in situ (DCIS) [ | PMC10576350 | |
Inclusion and exclusion criteria | blood-stained nipple | COMEDO, INVASIVE BREAST CANCER, BREAST CANCER, DCIS, MASS LESION, NECROSIS | Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS (unilateral or bilateral) in the last 90 days who were fit and willing to undergo surgery and able to provide written informed consent were eligible. Exclusion criteria included a previous diagnosis of ipsilateral DCIS or invasive br... | PMC10576350 |
Registration and randomisation pathway | DCIS | Enrolment to LORIS was a two-step process; registration followed by randomisation (see Fig. Registration and randomisation pathwayWomen were eligible for randomisation into LORIS if a diagnosis of low-risk DICS was confirmed by central review. Those eligible for LORIS were consented and randomised 1:1 to either surgery... | PMC10576350 | |
Measures | PMC10576350 | |||
Clinical Trial Questionnaire (CTQ) | Reasons for accepting or declining LORIS were collected using the CTQ [ | PMC10576350 | ||
Spielberger State Trait Anxiety Inventory (STAI) | The STAI consists of two sets of 20 questions, each scored on a 4-point scale [ | PMC10576350 | ||
EuroQol 5D-5 L (EQ-5D) | anxiety/depression | The EQ-5D is a health status measure, comprising five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) [ | PMC10576350 | |
Short Form Health Survey- 36 version 2 (SF-36v2) | pain | The SF-36v2 is a health status measure covering eight domains: physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems and mental health [ | PMC10576350 | |
Patient interviews | Semi-structured interviews were conducted with women willing to be randomised and those who were not (see | PMC10576350 | ||
Study information | Written materials and a film were produced to help women’s decision making about participation. Patient and public focus groups were held to inform the content of these materials [The film was divided into chapters for ease of re-viewing particular sections or could be played in full (see | PMC10576350 | ||
Support for sites | RECRUITMENT, BREAST | At the start of the project, communication workshops were delivered regionally to recruiting sites’ staff (see A year into the main trial, a funder monitoring visit highlighted recruitment rate concerns so a recovery plan was developed to increase recruitment. Postal surveys were sent to PIs, site leads, and then other... | PMC10576350 | |
Statistical analyses | DCIS | SPSS Statistics version 26 (IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IMB Corp) was used to produce descriptive statistics. Differences between acceptors (women with confirmed low-risk DCIS who were willing to be randomised) and decliners (women with confirmed low-risk DCIS who were not willing to be r... | PMC10576350 | |
Results | The CONSORT flow diagram is shown in Fig. CONSORT flow diagram | PMC10576350 | ||
Participants | The median age of the 181 acceptors was 58 years (range 46–88 years) and most were post-menopausal (117/181, 65%, post-menopausal; 19/181, 10%, peri-menopausal; 34/181, 19% pre-menopausal; 11/181, 6% menopausal status not known). The median age of the 92 acceptors interviewed post randomisation was 60 years (range 48–8... | PMC10576350 |
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