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Demographic and clinical characters of active and sham MM groups. | LATERAL EPICONDYLITIS | MM–Mill’s manipulation, y–year, m–meter, kg–kilogram, LE–Lateral epicondylitis, m–months. | PMC9925075 | |
Pre and post primary and secondary outcome measures of active and sham MM groups. | Depression, Anxiety | TENNIS ELBOW | *Significant, MM–Mill’s manipulationVAS–Visual analog scale, MRI–Magnetic resonance imaging, PRTEE—Patient-rated Tennis Elbow Evaluation, kg–Kilogram, GPI–Global perceived improvement, TSK–AV—The Tampa Scale for Kinesiophobia–adjusted version, HADS—Hospital Anxiety and Depression Scale, EuroQol EQ-5D –European quality of life–five dimension. | PMC9925075 |
3.2 Compliance with the study protocol | All registered outcome measures are reported in this manuscript. There was minimal loss to follow-up, as presented in | PMC9925075 | ||
3.3 Effects of the intervention | PMC9925075 | |||
3.3.1 Primary and secondary outcomes | Functional disability, pain | The time and group (4 × 2) linear mixed model (LMM) of primary variable (pain intensity—VAS) reports statistically significant difference (p<0.001) between active and sham groups at baseline, 4 weeks, 8 weeks and at 6 months follow up. The post intervention at 4 weeks 1.6 (CI 95% 0.97 to 2.22) shows improvement in the active group than sham group. The similar effects have been noted after 8 weeks and at 6 months 2.0 (CI 95% 1.66 to 2.33) follow up. The scores show significant changes (p<0.001) in the active group than sham group which is presented in The time and group (4 × 2) linear mixed model (LMM) of other variables (MRI T2 axial and coronal section, Ultrasound, Functional disability and Handgrip strength) report statistically significant difference (p = 0.001) between group A and group B at baseline, 4 weeks, 8 weeks and at 6 months follow up. The post intervention measure of percentage of injury through MRI and US image reports statistical change (p = 0.001) at 4 weeks’ duration. The similar effects were noted after 8 weeks and at 6 months follow up measurement, which is shown in | PMC9925075 | |
Pre and post primary outcome measures of active and sham MM groups. | depression | SECONDARY | The time and group (4 × 2) linear mixed model (LMM) of all the other variables (patient perception, kinesiophobia, depression and quality of life) reports statistically significant difference (p = 0.001) between active and sham groups at baseline, 4 weeks, 8 weeks and at 6 months follow up. The post intervention at 4 weeks of all secondary variables shows improvement in the active group than the sham group. The similar effects have been noted after 8 weeks and at 6 months follow up. The scores show significant changes (p = 0.001) in the active group than the sham group which is shown in | PMC9925075 |
Pre and post-secondary outcome measures of active and sham ESWT groups. | PMC9925075 | |||
Pre and post mean difference and confidence interval (upper limit and lower limit) of primary and secondary outcome scores of active and sham MM groups. | PMC9925075 | |||
3.4 Adverse events with the study intervention | ADVERSE REACTIONS | There was no adverse reactions or side effects noted in both the experimental and control groups during and after the corticosteroid injection and joint manipulation treatment. | PMC9925075 | |
4. Discussion | abnormal motion or compensation, pain | SECONDARY | Participants in the active group showed significant improvement compared to the sham group at various intervals in all the outcome measures. Sham group also showed a statistically significant improvement over time across the primary and secondary outcomes. A study by Olaussen M et al, observed that corticosteroid (CS) injection with physiotherapy has very good initial response in chronic LE [The therapeutically effective deep transverse friction massage with Mill’s manipulation provided in this study, consists of three sessions per week for four weeks’ which was considered as suitable for treating chronic LE. However, there was insufficient clinical evidence for the manual therapy alone in a long-term basis [Our study, measured the extent and percentage of injury through MRI and US and found that active group has significant improvement than sham group. Coel et al. found that the percentage of injury would correlate with abnormal motion or compensation caused by injury related pain [ | PMC9925075 |
4.1 Strengths and weaknesses | Type-1 errors | We used 8 weeks and 6 months’ follow-up with several outcomes to register the development of improvement after different interventions. The clinical setting and the choice of ordinary, well known physiotherapeutic approach ensured the external validity. This study strictly adhered to the CONSORT guidelines for randomized controlled trials. Randomization, concealed allocation and blinding strategies were performed, as these features are known to minimize bias. There were a few dropouts and the adherence to the intervention was good. We chose the apt statistical tests that would minimize Type-1 errors, since this is a non-serious and self-limiting condition. Only male subjects were included in the study. Including both genders may provide information about these interventions for both sexes and can generalize the results. A strict physiotherapy guideline, prohibited an individual adjustment of treatment and may have influenced the results. Although much research could be done on Mill’s manipulation alone, it would be interesting to study the efficacy on acute and sub-acute conditions, using similar inclusion criteria as in our study. | PMC9925075 | |
5. Conclusion | depression, pain | Corticosteroid injection with deep transverse friction massage and Mill’s manipulation is effective in terms of reducing pain, improving tissue healing, functional disability, handgrip strength, patient perception, kinesiophobia and depression status and, health related quality of life in people with lateral epicondylalgia. | PMC9925075 | |
Supporting information | PMC9925075 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (RTF)Click here for additional data file.(XLSX)Click here for additional data file.(DOCX)Click here for additional data file. | PMC9925075 | ||
References | PMC9925075 | |||
Background: | COPD | COPD | COPD causes high morbidity and mortality, emphasizing the need for palliative care. | PMC10227092 |
Aim: | COPD | COPD | To assess the effectiveness of palliative care in patients with COPD. | PMC10227092 |
Design: | depression, death, COPD, anxiety | COPD | Cluster randomized controlled trial (COMPASSION study; Netherlands Trial Register (NTR): NL7644, 07-04-2019). Healthcare providers within the intervention group were trained to implement palliative care components into routine COPD care. Patients completed questionnaires at baseline, after 3 and 6 months; medical records were assessed after 12 months. The primary outcome was quality of life (FACIT-Pal). Secondary outcomes were anxiety, depression, spiritual well-being, satisfaction with care, acute healthcare use, documentation of life-sustaining treatment preferences and place of death. Generalized linear mixed modelling was used for analyses. | PMC10227092 |
Setting: | Eight hospital regions in the Netherlands. | PMC10227092 | ||
Participants: | ACUTE EXACERBATION OF COPD | Patients hospitalized for an acute exacerbation of COPD and positive ProPal-COPD score. | PMC10227092 | |
Results: | COPD | COPD | Of 222 patients included, 106 responded to the questionnaire at 6 months. Thirty-six of 98 intervention patients (36.7%) received the intervention. Intention-to-treat-analysis showed no effect on the primary outcome (adjusted difference: 1.09; 95% confidence interval: −5.44 to 7.60). In the intervention group, fewer intensive care admissions for COPD took place (adjusted odds ratio: 0.21; 95% confidence interval: 0.03–0.81) and strong indications were found for fewer hospitalizations (adjusted incidence rate ratio: 0.69; 95% confidence interval: 0.46–1.03). | PMC10227092 |
Conclusions: | organ failure, COPD | COPD, SECONDARY | We found no evidence that palliative care improves quality of life in patients with COPD. However, it can potentially reduce acute healthcare use. The consequences of the COVID-19 pandemic led to suboptimal implementation and insufficient power, and may have affected some of our findings.
Patients in advanced stages of COPD suffer from high symptom burden, limited physical functioning and low quality of life.In oncological patients, timely initiation of palliative care alongside usual care improves quality of life and reduces healthcare use.
We did not find improvements in quality of life, but saw fewer intensive care admissions and a trend towards fewer hospital admissions in intervention group patients with advanced COPD.Study power was insufficient and not all patients received the intended palliative care intervention elements, possibly hampering reliable measurement of the clinical effectiveness.
Quality of life is a broad construct and may be difficult to target in patients with advanced organ failure; Future studies should consider a more proximal outcome measure, for example, coping with COPD.Lower acute healthcare use reduces healthcare costs and this is a relevant secondary outcome parameter to society as a whole; This finding needs further exploration. | PMC10227092 |
Introduction | cancer, death, COPD, deaths | COPD, SECONDARY, CANCER, CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Chronic obstructive pulmonary disease (COPD) causes considerable morbidity and is the third leading cause of death worldwide.In patients with cancer, quality of life can be improved and healthcare use reduced by timely initiation of palliative care.In a recent systematic review, only 4 out of 20 palliative care interventions in COPD had been evaluated in a powered controlled trial, and the effects on health outcomes remained inconclusive.Therefore, in the COMPASSION study, in half of the participating hospital regions, primary and secondary healthcare providers were trained to integrate palliative care components into routine COPD care. We assessed the effect on quality of life, emotional and spiritual well-being, acute healthcare use and place of death of patients with COPD. We hypothesized that intervention group patients would score better on quality of life and well-being, use less acute healthcare, and have a lower rate of in-hospital deaths than patients of hospitals in the control group. | PMC10227092 |
Methods | PMC10227092 | |||
Design | A cluster randomized controlled trial was performed. A detailed study protocol has been published previously. | PMC10227092 | ||
Setting | This study took place in pulmonary care departments of eight hospitals in the Netherlands, that collaborated with affiliated general practitioners, primary care nurses and palliative care consultation teams, further referred to as ‘hospital regions’ or ‘clusters’. | PMC10227092 | ||
Randomization | Hospital regions were randomized to the intervention or control condition (four clusters in each group) by an independent statistician, stratified by the number of COPD-related hospital admissions per year. | PMC10227092 | ||
Intervention | An integrated palliative care intervention was developed following national guidelines, literature and stakeholders’ input and comprised (1) palliative care conversations tailored to the patient’s needs, (2) care coordination and continuity and (3) aftercare if a patient had died (Description of the implementation strategy and integrated palliative care intervention of the Compassion study. Adapted from Broese et al. | PMC10227092 | ||
Participants | MAY | Between May 2019 and August 2020, patients admitted to the hospital for an acute exacerbation were invited by a pulmonologist or nurse to participate and subsequently screened with the ProPal-COPD tool (see ProPal-COPD tool.Inclusion and exclusion criteria of study participants. | PMC10227092 | |
Blinding | Complete blinding of participants for group allocation was impossible, but patients were not explicitly told whether their hospital was assigned to the intervention or control group. Further, healthcare providers of control regions were blinded for the ProPal-COPD score (whether positive and thus needing palliative care, or negative). | PMC10227092 | ||
Data collection | death, COPD | COPD | Demographics and patient-reported outcome measures were collected using a questionnaire at three time points. At baseline, patients completed a paper questionnaire during hospitalization. After 3 and 6 months, a follow-up questionnaire was sent to the patient’s home or email, depending on the patient’s preference. Patients were called by phone to remind them to complete the follow-up questionnaires. However, this was not always possible due to staff shortages in the research team. Medical record assessment was performed after 12 months to retrieve data on healthcare use, documentation of treatment preferences and date and place of death. Also, we assessed how many patients had received intervention components. Intervention patients who had had at least one palliative care conversation at the outpatient clinic with their pulmonologist and/or COPD nurse within 6 months after inclusion were considered to have received the intervention with fidelity. | PMC10227092 |
Outcome measures | The primary outcome was quality of life measured with the validated 46-item Functional Assessment of Chronic Illness Therapy-Palliative care (FACIT-Pal) scale. | PMC10227092 | ||
Data analyses | Data cleaning and descriptive statistics were performed using SPSS, version 25, and outcome analyses were conducted using R software, version 3.6.2. We calculated that 347 participants were required to find an effect of minimum nine points at the primary outcome with an assumed standard deviation of 25, taking clustering at hospital level and a loss to follow-up of 10% into account. | PMC10227092 | ||
Ethics approval and consent | All participants received oral and written study information and gave written informed consent. Ethical approval was granted by the Medical Ethics Committee of Arnhem-Nijmegen (file number 2018-4833) on 15 October 2018. | PMC10227092 | ||
Results | PMC10227092 | |||
Participant characteristics | COPD | MAY, COPD | Between May 2019 and August 2020, 735 patients admitted to the hospital for an acute exacerbation COPD were screened for eligibility (Flow diagram of inclusion of participants and response rates of questionnaires at baseline (T0), after 3 months (T3) and 6 months (T6).Demographic- and clinical characteristics of participants in the intervention and control group and participants with at least one complete follow-up FACIT-Pal score.Data presented as percentage unless stated otherwise.BMI: body mass index; FEV1: forced expiratory volume in the first second; MRC: Medical Research Council; SD: standard deviation. | PMC10227092 |
Intervention delivery | In the intervention group, an outpatient palliative care conversation occurred in 36 of 98 patients within 6 months after inclusion (36.7%). In eight patients, a conversation took place later than after 6 months. Reasons for no outpatient palliative care conversation were: transferral to a different care setting (primary care, rehabilitation centre or nursing home) (In the control group, an outpatient palliative care conversation occurred in 4 of 124 patients within 6 months after inclusion (3.2%). The occurrence of these conversations was in the intervention group statistically significantly higher than in the control group with an odds ratio of 17.42 (95% CI: 5.93–51.17), | PMC10227092 | ||
Discussion | PMC10227092 | |||
Main findings | COPD | COPD, SENSITIVITY | In this cluster randomized controlled trial, we assessed the effectiveness of palliative care components integrated into regular COPD care. We found no effects on quality of life nor other patient-reported outcome measures. However, intervention patients were less frequently admitted to the ICU than control patients, and there was a strong indication for fewer hospital admissions. Sensitivity analyses did not corroborate these findings but showed that the intervention increased documentation of life-sustaining treatment preferences. | PMC10227092 |
Interpretation of findings | organ failure, COPD | COPD, RECRUITMENT, DISEASE COURSE | Similar to our study, a recent systematic review found no effect of palliative care interventions on the quality of life of patients with COPD; effects on acute healthcare use were inconclusive.Our findings could be explained in several ways. First, we did not reach sufficient statistical power to detect effects on the primary outcome measure reliably. To increase recruitment, we lowered the cut-off value of the ProPal-COPD tool after 6 months, but then the COVID-19 pandemic again hampered recruitment rates.Second, implementation was suboptimal. Because of several reasons, such as the COVID-19 pandemic, a significant part of the intervention group did not receive an outpatient palliative care conversation. Also, coordination and continuity of care between hospital and primary care remained challenging. The barriers and facilitators to successful implementation we encountered have been published in our process evaluation article separately.Effects at the provider’s level tended to be more prominent in our study, probably because our implementation strategy was at healthcare provider level: they were trained and guided to implement palliative care components. Indeed, many more outpatient palliative care conversations took place than in the control group, and treatment preferences were documented more often. Also, we found that self-efficacy in palliative care provision increased in trained healthcare providers.Third, quality of life and other well-being outcomes are broad constructs influenced by many factors. The potential to improve overall quality of life may be limited in advanced organ failure, and the fluctuations in the disease course further complicate such outcome measurements.Although we did not find an effect on quality of life, our study in COPD is the first controlled study that found a lower rate of ICU admissions in the palliative care group, | PMC10227092 |
Strengths and limitations | death, COPD | COPD | This study is the first large randomized controlled trial assessing the effectiveness of palliative care integrated into regular COPD care. As part of a hybrid type 2 effectiveness-implementation study,However, our study also has limitations. Next to insufficient study power, we had a high rate of missing data due to the death of participants and high non-response to follow-up questionnaires. Missing data are expected in palliative care studies and increase with more items, quality of life questionnaires and longer follow-up time. | PMC10227092 |
Conclusions | COPD | COPD, DISEASE | The effect of integrated palliative care on clinical outcomes in patients with COPD remains inconclusive. We found no evidence that palliative care improves quality of life in patients with COPD, but it can potentially reduce ICU admissions. Better implementation of palliative care components is needed to enhance reliable effect evaluation. Future research should consider using an outcome measure related to coping with COPD that is easy to complete by patients with advanced disease. | PMC10227092 |
Supplemental Material | PMC10227092 | |||
References | PMC10227092 | |||
Supplementary Information | depression, anxiety | The aim of the present research was to develop and test the efficacy of a novel online contingent attention training (i.e., OCAT) to modify attention and interpretation biases, improve emotion regulation, and reduce emotional symptom levels in the face of major stressors. Two proof-of-principle studies were carried out. In study 1, 64 undergraduates who were about to start a major stressful period (i.e., final exams) were randomized to undergo 10 days of active OCAT or a sham-control training. Emotion regulation (habitual use of rumination and reappraisal) and symptom levels (depression and anxiety) were assessed before and after the intervention. In study 2The online version contains supplementary material available at 10.1186/s41235-023-00480-3. | PMC10166036 | |
Keywords | PMC10166036 | |||
Significance statement | depression, anxiety | DISORDERS | Cognitive biases (e.g., attention and interpretation biases) are conceptualized as central mechanisms for the onset and maintenance of emotional disorders such as depression and anxiety. Cognitive models have posited that these biases emerge under stressful situations, impairing peoples’ ability to regulate negative emotions, ultimately leading to the appearance of emotional symptoms. Given the current worldwide prevalence of emotional disorders and emotion dysregulation problems, there is a clear need for new approaches targeting these cognitive biases at a broad and accessible scale.
In the present two proof-of-principle studies, we adapted a well-established cognitive biases modification paradigm (CBM) into a novel smartphone app (OCAT) for training participants’ attention and interpretation biases during two different naturalistic stressful situations. In Study 1, undergraduate students completed the OCAT training (10 session per day) when they were facing their final examination period. In Study 2, people from the community completed the same training during the occurrence of a very restrictive COVID-19 lockdown. Overall, these studies showed the efficacy of the OCAT app to modify both attention and interpretation biases, as well as transfer effects to improve emotion regulation and reduce emotional symptoms.These findings shed light regarding the causal role of cognitive biases on emotion regulation and emotional symptoms. Moreover, provide further encouragement for the further development and dissemination of CBM paradigms that can be applied in online formats.
| PMC10166036 |
General introduction | depression, Depression, ABM, anxiety | DISORDERS | Depression and anxiety disorders are highly prevalent worldwide (Steel et al., Importantly, novel approaches conveying the use of precise knowledge on neurocognitive mechanisms of stress and emotional dysfunctions have been developed in recent years (see, for instance, Goodwin et al., These attentional and interpretation biases are interrelated (Everaert et al., Relatedly, recent research has shown that during the COVID-19 lockdown of 2020, a clearly major stressful situation, interpretation and attention biases had a large impact on psychological adjustment to the situation (Blanco et al., During the last two decades, a growing body of research under the umbrella term of attention bias modification (ABM) has emerged, developing procedures to train and modify attention biases related to emotional dysfunctions (Koster et al., A particularly promising approach is the (eye)gaze-contingent feedback training (ECAT; Sanchez et al., Using this ECAT, it has been found that, in comparison with the control group, the training group showed less attention bias (AB) to negative information (measured by independent dot-probe and eye-tracking tasks) and that AB changes led to improvements in participants’ reappraisal abilities, to reductions in state rumination, and ultimately to fewer negative emotions during an emotion regulation task (Sanchez et al., Despite the potential of this training approach, the necessity of advanced eye-tracking techniques for delivery of the ECAT may limit its use as a clinical intervention. Therefore, a new variant of this training, the mouse-based contingent attentional training (MCAT) was developed (Sanchez-Lopez et al., Therefore, the main aim of the present research was to examine the efficacy of a new variant, the Online Contingent Attentional Training (OCAT), developed as a fully accessible online app that can be executed either on computers or on mobile phones. The novel OCAT variant follows the exact same principles used in MCAT and is designed to modify attention and interpretation biases and transfer to improve emotion regulation and emotional symptomatology. Across a series of two proof-of-principle studies, a 10-session version of OCAT was validated, analyzing its transfer effects to the use of emotion regulation strategies (i.e., rumination and reappraisal) and to emotional symptomatology levels (i.e., depression and anxiety). Accumulating research has shown that mechanisms of vulnerability to emotional dysfunctions such as attention and interpretation biases can emerge and contribute to dysfunctions particularly at conditions of major stress (see, for instance, Everaert et al., | PMC10166036 |
Study 1. Effectiveness of OCAT to target cognitive biases, emotion regulation and psychological symptoms during a stressful exam period in undergraduate students | The main aim of this first study was to validate the new OCAT variant and analyze its efficacy as a 10-session online protocol to modify both attention and interpretation biases and transfer to improvements in the use of emotion regulation strategies and/or emotional symptomatology. Following previous research (Sanchez-Lopez et al., | PMC10166036 | ||
Method | PMC10166036 | |||
Participants | Sixty-four undergraduate students took part in the study in exchange for course credits. All participants were recruited three-weeks before they began their final examination period and they were then randomly allocated to start the active OCAT or the control sham-training group in the same time period (i.e., within the same week). A simple randomization procedure, where all participants had the same probability of being allocated to the active OCAT or the control sham-training group, was carried out. This procedure was performed through a macro excel file which automatically assign the participants to one of the two experimental conditions. Nine participants of the active OCAT group and 5 of the control sham-training group were excluded from the analysis due to dropout and/or technical issues. Additionally, 2 participants were identified as outliers, defined as having scores ± 2.5 SD on the baseline assessment of the main outcome (i.e., attentional bias index), and were excluded (see Additional file General procedure | PMC10166036 | ||
General procedure | As depicted in Fig. | PMC10166036 | ||
Data analysis plan | Prior to the analysis, normality and homoscedasticityFinally, exploratory analyses were conducted to test the influence of cognitive bias changes as a response of cognitive training to account for training effects in transfer psychological measures (see Sanchez et al., | PMC10166036 | ||
Results | PMC10166036 | |||
Exploratory analyses of relations between in-training cognitive and symptom changes | ’ depression | Analyses showed that larger decreases in the time attending to negative words were significantly related to larger decreases in participants’ depression levels from pre- to post-training ( | PMC10166036 | |
Interim discussion | depressive, anxiety | The aim of this first pilot study was to analyze the efficacy of OCAT on targeting attention and interpretation biases as well as its transfer effects to emotion regulation and emotional symptom levels in an unselected sample of undergraduate students who were about to confront a naturalistic stressor (i.e., beginning of final exams). Our results partially supported our hypotheses.First, we hypothesized that, after the training, participants in the OCAT group would show a larger attentional processing of positive information than their counterparts in the control group. Our results revealed that, after the training, there were no differences between groups in the time they spent attending towards positive and negative information. However, analyses of specific patterns of change showed that participants in the OCAT group specifically decreased their attention to negative information to a larger extent than participants in the control group. Previous research has shown that the relation of attention biases towards negative information and emotional symptomatology follows a gradient (e.g., higher negative attention bias, higher depressive symptomatology—see Blanco et al., In terms of transfer to emotion regulation, our hypotheses stated that, after the training, OCAT participants (in comparison to the control participants) would report lower use of rumination, and higher use of reappraisal. Our results revealed that OCAT group indeed showed a significant reduction of brooding rumination after training. This result is in line with previous evidence found using the eye-tracking and computer-based variants of this training (see Sanchez et al., Regarding transfer effects to emotional symptoms, in line with our prediction, there were group differences after training in levels of anxiety in the face of naturalistic stress. The control group showed a significant increase of their levels of anxiety from Time 1 to Time 2, whereas these patterns of increased symptom levels in the face of naturalistic stress were absent in the training group. Previous experimental research has proposed that attention bias modification paradigms could act as a vaccine against stressful situations (Browning et al., In sum, the results of this first study show preliminary evidence regarding the efficacy of the OCAT procedure to modify specific components of attention (i.e., total time attending negative information) and interpretation biases. We also observed transfer effects to emotion regulation and symptom levels under stress conditions. In a second study we sought to replicate these findings and to extend them when considering OCAT efficacy for individuals from the general population in the face of a major stressor. | PMC10166036 | |
Study 2. Validation and effectiveness of OCAT to target cognitive biases, emotion regulation and psychological symptoms during COVID-19 lockdown in a community sample | depression, anxiety | The beginning of COVID-19 pandemic comprised a significant major stressor for the general population, resulting in increased rates of depression and anxiety (Shevlin et al., | PMC10166036 | |
Method | PMC10166036 | |||
Participants | Fifty-eight participants took part in the study voluntarily. They were recruited by advertising on social media and social networks. As in Study 1, participants were randomly allocated to the active OCAT and the control sham-training group through a simple randomization procedure. Six participants of the active OCAT group, and 4 of the control sham-training group, were excluded from analyses due to dropout and/or technical issues. The final active OCAT group was composed of 23 participants (83% female; mean age = 36.78 years— | PMC10166036 | ||
General procedure | post-training cognitive bias | MINOR, RECRUITMENT | The general procedure was identical to study 1, except for the following minor differences. Due to the COVID-19 lockdown restrictions, participants were contacted through advertising in social media and social networks, and the entire procedure was conducted online. Thus, after participants were randomized to the OCAT or the sham-control group, they were provided with online instructions on how to complete the psychological and emotion regulation measures as well as on how to download, install, and use the mobile training app. First, participants signed an online consent form, before completing the psychological measures via Qualtrics software. Then, they installed the app and completed attention and interpretation biases as baseline assessment (Time 1). Immediately afterwards, they started the first online session of the OCAT or sham-control. Identically to study 1, they then completed a total of 10 sessions of online training, on a daily basis, with the same instructions as in Study 1. As in Study 1, the post-training cognitive bias assessments (Time 2) were collected immediately after completing the last training session, whereas the post-training psychological assessments were collected the day after the last training session via Qualtrics. Given the changing situation experienced across the initial COVID-19 lockdown period, it was decided to restrict recruitment for the study to a specific short-time period during lockdown. Sample recruitment was specifically performed during one week at the end of April 2020 (a very restrictive period of the lockdown in Spain). The study was conducted in compliance with the Declaration of Helsinki (World Medical Association, | PMC10166036 |
Experimental task and materials | Experimental task and materials were the same as in study 1. | PMC10166036 | ||
Attention and interpretation dependent variables | Attention and interpretation were assessed in the same manner as in study 1. Further, reliability analyses were conducted on the measures in the current study. As in study 1, the results showed excellent internal consistencies of both attention and interpretation bias measures at Time 1 and Time 2 (see Table Internal consistency for each scale and cognitive bias measure at each assessment pointα = Cronbach’s alpha; λ = Guttman split-half coefficient | PMC10166036 | ||
Psychological measures | depression, anxiety | Given the null finding for reappraisal transfer in study 1, reappraisal was assessed using a different reappraisal measure, the reappraisal subscale of the Emotion Regulation Questionnaire (ERQ—Gross & John, The rest of the self-reported variables (i.e., depression, anxiety, and brooding rumination) were assessed using the same instruments as in the study 1. In all cases, internal consistencies of the instruments in the study were good (see Table | PMC10166036 | |
Data analysis plan | The data analysis plan followed in the present study was identical to the one used in the study 1. | PMC10166036 | ||
Results | PMC10166036 | |||
Effects of the OCAT on cognitive bias measures | PMC10166036 | |||
Interim discussion | anxiety | Previous research has shown that attention and interpretation biases play a major role in psychological adjustment during COVID-19 lockdown (Blanco et al., Following the results of Study 1, we also hypothesized that training-related improvements in attention and interpretation biases would transfer to improved rumination and anxiety levels. Different to Study 1, groups did not differ in emotion regulation or symptom levels from pre- to post-training. This could be accounted by a larger heterogeneity in the characteristics of the community sample tested in Study 2. Furthermore, the sample of the present study was undergoing a major stressor when starting the study, whereas the sample of Study 1 was anticipating an upcoming stressor. The different results found in each study suggest the possibility that this type of CBM trainings act as stress buffer (Browning et al., In sum, the results of this second study further supported the efficacy of the OCAT procedure to modify both attention and interpretation processing during the occurrence of a major stressor and point out a potential transfer to emotion regulation and symptom levels via cognitive bias modification. | PMC10166036 | |
General discussion | depression, anxiety | MACLEOD | Cognitive processing (e.g., attention and interpretation) of emotional information have been postulated as crucial variables implicated in the onset and maintenance of diverse forms of psychopathology such as depression and anxiety (Mathews & MacLeod, Overall, the results of both studies show that the OCAT app is effective to modify attention and interpretation processes and that these changes seem to transfer to reductions of habitual use of brooding rumination and buffer against anxiety in the face of naturalistic stressors. The OCAT smartphone app was developed based on the same training principles of original ECAT and MCAT procedures (Sanchez et al., However, despite the promising results of these proof-of-principle studies, inconsistencies were found between Study 1 and Study 2, and future research should address them. For instance, whereas in Study 1 group-based transfer effects to brooding rumination and anxiety levels were found; in Study 2 these transfer effects emerged only from individual-based exploratory indirect effect models. As explained above, these differences could be accounted by the different nature of the stressors (the exam period in Study 1 vs. the COVID-19 lock-down in Study 2) as well as by differences in the sample characteristics (undergraduate students in Study 1 vs. community sample in Study 2). Additionally, there is still scarce evidence regarding the optimal number of sessions for these types of trainings. Future studies should address the effective-optimal dose of OCAT to maximize emotional improvements resulting from its use during periods conveying major stress conditions (see Vazquez et al., Other issues remain also unclear and should be analyzed in further pre-registered randomized control trials. For instance, the training provides attention-contingent feedback to train participants across each trial. This feedback is thought to enhance participants’ awareness of their attentional patterns, which would also facilitate the use of top-down cognitive strategies to regulate attention (Bernstein & Zvielli, Despite of these limitations, the OCAT app opens a new venue to implement an online training tool able of modifying attention and interpretation processes and transferring to promote adaptive emotion regulation and stress resilience. Of note, this app is suited to allow reaching large-scale clinically or at-risk populations. This is in line with claims regarding the necessity of theory-driven and empirically informed interventions able to intervene causal mechanism on psychopathology (NIMH, | PMC10166036 |
Acknowledgements | We thank Ricardo Rey and Angela Socastro for their collaboration during the sample recollection of both studies. | PMC10166036 | ||
Author contributions | TB | IB: conceptualization, methodology, formal analysis, investigation, data curation, writing—original draft preparation; OM-G: methodology, investigation, data curation, writing—review & editing; TB: investigation, data curation, writing—review & editing. EHWK: supervision, writing—review & editing; RDR: supervision, writing—review & editing; AS-L: conceptualization, methodology, writing—review & editing, supervision, project administration, funding acquisition. All authors read and approved the final manuscript | PMC10166036 | |
Funding | This work was supported by a grant of the Program for the Attraction of Scientific Talent of the Community of Madrid (Spain), reference 2017-T1/SOC-5359, and grants of the Spanish Ministry of Science, Program “Generation of Knowledge” ref. PGC2018-095723-A-I00; and ref. PID2021-127480NB-I00, awarded to the last author. The funding source were no involved in study design either the collection, analysis, or interpretation of data. Also, the funding source was not involved in writing the present manuscript in any submission decision. | PMC10166036 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10166036 | ||
Declarations | PMC10166036 | |||
Ethics approval and consent to participate | These studies was approved by the Complutense University Ethical Committee. All participants signed a consent form prior to their participation on the studies. | PMC10166036 | ||
Consent for publication | Not applicable. | PMC10166036 | ||
Competing interests | Authors report no competing interests. | PMC10166036 | ||
References | PMC10166036 | |||
Background | PONV, postoperative nausea and vomiting, pain | Butorphanol slightly influences the respiratory and circulatory systems, has a better effect on relieving the discomfort caused by mechanical traction, and has a low incidence of postoperative nausea and vomiting (PONV). Combined butorphanol and propofol may suppress postoperative visceral pain, which is avoidable in gastrointestinal endoscopy. Thus, we hypothesized that butorphanol could decrease the incidence of postoperative visceral pain in patients undergoing gastroscopy and colonoscopy. | PMC10044711 | |
Methods | visceral pain, pain | ADVERSE EVENTS, SECONDARY | This was a randomized, placebo-controlled, and double-blinded trial. Patients undergoing gastrointestinal endoscopy were randomized to intravenously receive either butorphanol (Group I) or normal saline (Group II). The primary outcome was visceral pain after the procedure 10 min after recovery. The secondary outcomes included the rate of safety outcomes and adverse events. Postoperative visceral pain was defined as a visual analog scale (VAS) score ≥ 1. | PMC10044711 |
Results | A total of 206 patients were enrolled in the trial. Ultimately, 203 patients were randomly assigned to Group I ( | PMC10044711 | ||
Conclusions | visceral pain | The trial indicated that adding butorphanol to propofol results in a lower incidence of visceral pain after surgery without noticeable fluctuations in circulatory and respiratory functions for gastrointestinal endoscopy patients. | PMC10044711 | |
Trial registration | Clinicaltrials.gov NCT04477733 (PI: Ruquan Han; date of registration: 20/07/2020). | PMC10044711 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-02053-9. | PMC10044711 | ||
Keywords | PMC10044711 | |||
Background | pain, Cancer | GASTROINTESTINAL CANCER, CANCER | More than two million people die of gastrointestinal cancer, accounting for approximately 60% of new cases, based on Global Cancer Statistics 2018 [Propofol is widely used in endoscopy due to its fast onset of action, short action time, and quick and complete postoperative recovery [Butorphanol is a mixed opioid receptor agonist and antagonist that acts on κ receptors [In this randomized controlled study, we intended to confirm that butorphanol can significantly improve postoperative visceral pain, reduce the dosage of propofol needed and improve quality in patients undergoing gastroscopy and colonoscopy. | PMC10044711 |
Methods | PMC10044711 | |||
Study design and participants | This dual-center, randomized, placebo-controlled study was conducted at Beijing Tiantan Hospital, Capital Medical University, and Beijing Daxing People’s Hospital between August 14th, 2020, and September 30th, 2021. This study was approved by the China Ethics Committee of Registering Clinical Trials (Registration number: ChiECRCT20200200) and registered at Clinicaltrials.gov (NCT04477733, 20/07/2020)) in July 2020. All patients or their legal representatives provided written informed consent. The study followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines.We recruited adult patients aged 18 to 65 with an American Society of Anesthesiologists physical status from I to III who underwent colonoscopy or gastroscopy. The exclusion criteria included patients with a body mass index > 30 kg/m | PMC10044711 | ||
Blinding and randomization | Patients were randomly assigned to receive butorphanol (Group I) or normal saline (Group II) in a 1:1 ratio based on computer-generated stratified randomization numbers. The random numbers were sealed in separate opaque envelopes until the analysis was complete. Patients in Group I received 10 μg/kg butorphanol intravenously 3 min before the intravenous injection of propofol. The patients assigned to Group II received an identical volume of normal saline at the same infusion rate.The investigators did not participate in other processes while preparing the research solution. A designated staff prepared the solution, enclosed in a dark syringe (volume: 5 ml) labeled "study solution," The two solutions seemed identical. Randomization was blinded to the participants, chief anesthesiologists, and outcome assessors. | PMC10044711 | ||
Perioperative management | intravascular hypovolemia | The regimens were standardized in both groups. Patients were deprived of water for 2 h and fasted for 8 h before surgery. Based on the requirements of anesthesia and surgery, venous access (central vein of the upper limb) was established. As perioperative fasting and bowel preparation are believed to cause intravascular hypovolemia, preemptive intravenous fluid was infused with 10–15 ml/kg normal saline. Standard intraoperative monitoring, which included electrocardiogram (ECG), heart rate (HR), blood pressure (BP), respiratory rate (RR), and pulse oxygen saturation (SpO | PMC10044711 | |
Data collection and outcomes | nausea or vomiting, bradycardia, visceral pain, fatigue, pain, dizziness, hypoxemia, hypotension, headache, abdominal bloating | ADVERSE EVENTS, SECONDARY | Baseline data were recorded, such as age, sex, height, weight, body mass index, ASA physical status, and type of operation. The MAP, HR, RR, and SpOThe primary outcome was the incidence of visceral pain after the procedure. Because there is no universal scale for quantifying visceral pain, we defined a visual analog scale (VAS) score of ≥ 1 10 min after recovery as visceral pain. The secondary outcomes were visceral pain at 20 and 30 min after recovery, propofol consumption, the incidence of injection pain caused by propofol, episodes of hypotension (defined as an MAP less than 60 mmHg or 30% of the values before the induction of anesthesia) or bradycardia (defined as an HR less than 60 bpm), the operation time, the recovery time, and the adverse events at 24 h after recovery, such as fatigue, nausea or vomiting, abdominal bloating, dizziness or headache, hypoxemia (blood oxygen saturation below 90% for more than a minute or requiring any airway intervention), and involuntary body movement. | PMC10044711 |
Sample size calculation | pain | We used PASS software to calculate the necessary sample size for this study. A cohort study reported that 45% of participants (124 of 277) undergoing colonoscopy and gastroscopy complained of pain during follow-up [ | PMC10044711 | |
Statistical analysis | visceral pain | SECONDARY | The data were analyzed using SPSS 26.0, and the figures were created by GraphPad Prism 9.0. All analyses were based on the intention-to-treat (ITT) principle. The Kolmogorov–Smirnov test was used to analyze continuous outcomes to judge the normality of their distributions. Normally distributed continuous variables were summarized as the mean value ± standard deviation and were compared using independent t tests. Skewed continuous variables were summarized as the median value and interquartile range and were compared using the Mann–Whitney U test. As appropriate, categorical variables were summarized as the number and percentage and compared using the chi-square or Fisher’s exact test. The primary endpoint was the incidence of visceral pain in the recovery room, and the chi-square test was used to compare the differences between the two groups. The risk ratios and 95% confidence intervals were reported for the primary and secondary outcomes. MAP, HR, RR, and SpO | PMC10044711 |
Results | PMC10044711 | |||
Visceral pain | nausea or vomiting, bloating, visceral pain, fatigue, abdominal pain, pain, dizziness, hypoxemia, headache, abdominal bloating | ADVERSE EVENTS, ADVERSE EVENT | The incidence of visceral pain at 10 min after recovery was significantly lower with butorphanol (31.5% Comparison of efficacy and safety outcomes (median and interquartile range or frequency and percentage)Incidence of visceral pain recovery at 10 (The incidence of visceral pain at 20 and 30 min after recovery showed a similar change (Fig. Perioperative monitoring parameters (MAP, SpO2 and RR).The MAP, SpOChanges in MAP, HR, SpO2, and RR. MAP, HR: Normal distribution, mean, and SD. SpO2, RR: Nonnormal distribution, median, and upper/lower limit. T0, at admission; T1, before anesthesia; T2, 5 min after propofol administration; T3, at the end of the operation; T4, 5 min in the PACU; T5, 10 min after recovery; T6, 30 min after recovery. Only after the administration (T2, t = -2.716, Adverse events.Only one patient in the butorphanol group developed fatigue during the operation and recovery room. After 24 h of recovery in the butorphanol group, the number of people with nausea or vomiting, abdominal bloating, dizziness, or headache was 2, 7, and 5, respectively. In Group II, only seven people had abdominal pain and bloating. No cases of hypoxemia or body movements were reported. There were no significant differences between the two groups in adverse events ( | PMC10044711 |
Discussion | hypoxemia, visceral pain, fatigue, pain | ADVERSE EVENTS, COMPLICATIONS | This study demonstrates that butorphanol results in a statistically lower incidence of visceral pain after surgery and reduced propofol consumption for gastrointestinal endoscopy without noticeable fluctuations in circulatory and respiratory functions. Intravenous butorphanol neither prolongs recovery time nor increases adverse events.First, we selected 10 μg/kg butorphanol as the administration dosage in this study. One reason is that the patients had minimal discomfort at this dose in our pretest. The other is that 9.07 μg/kg of butorphanol was more effective than sufentanil for gastrointestinal endoscopy sedation and notably reduced the recovery time [The incidence of visceral pain was significantly lower in the butorphanol group at 10, 20, and 30 min after recovery. This is consistent with most previous studies [Butorphanol infusion allowed for a noticeable reduction in propofol consumption, which was more pronounced in colonoscopy than in gastro-colonoscopy. This may be because of the prolonged operation time in gastro-colonoscopy. Forster and colleagues found similar outcomes for lidocaine: lidocaine resulted in a 50% reduction in propofol dose requirements during colonoscopy and significantly lower postcolonoscopy pain and fatigue [The incidence of hypoxemia was between 8.2% and 15% [Our study should be interpreted with several limitations. As mentioned earlier, the high dosage of butorphanol (10 μg/kg) makes it difficult to find significant differences in the incidence of complications. We should conduct more research on the dosage of butorphanol. Finally, we recorded the total propofol consumption, so it is unclear which stage (the induction of sedation or during the infusion of study medications) caused the increase in the propofol dosage.In conclusion, butorphanol decreases the incidence of visceral pain and propofol consumption for gastrointestinal endoscopy with minimal fluctuations in circulatory and respiratory functions. However, the rate of adverse events and recovery time did not differ significantly after the use of butorphanol. The clinical application needs to be weighed according to the actual situation of the patients. | PMC10044711 |
Acknowledgements | Not Applicable. | PMC10044711 | ||
Authors’ contributions | HL | Each author's individual contributions to the manuscript are as follows: HL, RH: Conceptualization and design. JW, HL: Investigation. XW: Writing - Original draft of the manuscript and statistical analysis. HL, RH: Writing - Review & Editing. XW, HL and RH had full access to the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. JW. and XW contributed equally to this work. All authors read and approved the final manuscript. | PMC10044711 | |
Funding | No funding. | PMC10044711 | ||
Availability of data and materials | The datasets generated and analyzed during the current study are not publicly available due to institutional restrictions but are available from the corresponding author on reasonable request. | PMC10044711 | ||
Declarations | PMC10044711 |
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