scholarly journals Using Positive Attribute Framing to Attenuate Nocebo Side Effects: A Cybersickness Study

2021 ◽  
Author(s):  
Alanna Mao ◽  
Kirsten Barnes ◽  
Louise Sharpe ◽  
Andrew L Geers ◽  
Suzanne G Helfer ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Informed Consent ◽  
Side Effects ◽  
Healthy Volunteers ◽  
Empirical Data ◽  
Side Effect ◽  
Spatial Awareness ◽  
Nocebo Effect ◽  
Positive Attribute ◽  
To Receive

Abstract Background Side effect warnings can contribute directly to their occurrence via the nocebo effect. This creates a challenge for clinicians and researchers, because warnings are necessary for informed consent, but can cause harm. Positive framing has been proposed as a method for reducing nocebo side effects whilst maintaining the principles of informed consent, but the limited available empirical data are mixed. Purpose To test whether positive attribute framing reduces nocebo side effects relative to negative framing, general warning, and no warning. Methods Ninety-nine healthy volunteers were recruited under the guise of a study on virtual reality (VR) and spatial awareness. Participants were randomized to receive positively framed (“7 out of 10 people will not experience nausea”), negatively framed (“3 out of 10 people will experience nausea”), general (“a proportion of people will experience nausea”), or no side effect warnings prior to VR exposure. Results Receiving a side effect warning increased VR cybersickness relative to no warning overall, confirming that warnings can induce nocebo side effects. Importantly, however, positive framing reduced cybersickness relative to both negative framing and the general warning, with no difference between the latter two. Further, there was no difference in side effects between positive framing and no warning. Conclusions These findings suggest that positive framing not only reduces nocebo side effects relative to negative framing and general warnings, but actually prevents nocebo side effects from occurring at all. As such, positive attribute framing may be a cheap and ethical way to reduce nocebo side effects.

The Nocebo Effect and Informed Consent—Taking Autonomy Seriously

2020 ◽  
Vol 29 (2) ◽  
pp. 223-235
Author(s):  
SCOTT GELFAND
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Medical Treatment ◽  
Side Effect ◽  
Patient Autonomy ◽  
The Other ◽  
Nocebo Effect ◽  
Other Hand ◽  
Patient Will ◽  
Practical Tool

AbstractThe nocebo effect, a phenomenon whereby learning about the possible side effects of a medical treatment increases the likelihood that one will suffer these side effects, continues to challenge physicians and ethicists. If a physician fully informs her patient as to the potential side effects of a medicine that may produce nocebogenic effects, which is usually conceived of as being a requirement associated with the duty to respect autonomy, she risks increasing the likelihood that her patient will experience these side effects and therefore suffer (unnecessary) harm, a violation of the duty of nonmaleficence. If, on the other hand, she intentionally withholds side effect information in an effort to protect her patient from suffering unnecessary harm from side effects, which is consistent with the duty of nonmaleficence, she violates the duty to respect patient autonomy. In this paper, the author discusses several previous attempts to deal with the nocebo effect and explains their weaknesses. He then proposes a means of managing the nocebo effect and argues that it does not share the weaknesses found in previous approaches. He concludes with a discussion of a simple, yet practical tool that might help clinicians manage the tension resulting from the nocebo effect.

scholarly journals Informing About the Nocebo Effect Affects Patients’ Need for Information About Antidepressants—An Experimental Online Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Yvonne Nestoriuc ◽  
Yiqi Pan ◽  
Timm Kinitz ◽  
Ella Weik ◽  
Meike C. Shedden-Mora
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Information Seeking ◽  
Side Effect ◽  
Experimental Manipulation ◽  
Informational Needs ◽  
Nocebo Effect ◽  
Chi Square ◽  
Beneficial Effects ◽  
Need For Information

Relevance: Understanding patients’ informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects.Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients’ need for information about antidepressants.Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs.Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [X(4,97)2 = 12.714, Cramer’s V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [X(4,97)2 = 14.878, Cramer’s V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151).Conclusions: Learning about the nocebo effect can alter patients’ informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

scholarly journals Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Statistical Power ◽  
Controlled Trial ◽  
Treatment Options ◽  
Cognitive Remediation ◽  
Negative Effects ◽  
Metacognitive Training ◽  
To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

A Multicentre Double Blind Trial of Fluoxetine versus Amitriptyline in the Treatment of Depressive Illness

1993 ◽  
Vol 27 (1) ◽  
pp. 49-55 ◽  
Author(s):  
Fiona K. Judd ◽  
Kate Moore ◽  
Trevor R. Norman ◽  
Graham D. Burrows ◽  
Ramesh K. Gupta ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Serotonin Reuptake ◽  
Depressive Illness ◽  
Fixed Dose ◽  
Side Effect Profile ◽  
Double Blind Trial ◽  
Double Blind ◽  
Antidepressant Efficacy ◽  
To Receive

The antidepressant efficacy and side effect profile of a fixed dose of 20 mg/day of fluoxetine, a specific serotonin reuptake inhibitor, were compared to those of amitriptyline. Fifty-eight patients with DSM-III-R depression were randomly assigned to receive either fluoxetine or amitriptyline. Fifty-six patients (fluoxetine N = 23, amitriptyline N = 23) completed the 6 week study. Comparable antidepressant efficacy was demonstrated for the two drugs. Patients taking fluoxetine reported less side-effects than those taking amitriptyline.

COVID 19 vaccine in patients of hypercoagulable disorders: a clinical perspective

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Nitin Ashok John ◽  
Jyoti John ◽  
Praful Kamble ◽  
Anish Singhal ◽  
Vandana Daulatabad ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Vascular Endothelial Cell ◽  
Blood Stasis ◽  
Vascular Endothelial ◽  
The Public ◽  
Care Workers ◽  
Review Management ◽  
Rare Side Effect ◽  
To Receive

Abstract COVID 19 is an infectious disease caused by severe acute respiratory syndrome corona virus 2. Thromboembolism has been a characteristic manifestation in most of the severely ill COVID-19 patients. Thromboembolism in COVID 19 infection is attributed to injury to the vascular endothelial cell, hypercoagulability and blood stasis. The hypercoagulable state of blood and thrombophilic diseases leads to hypercoagulability. COVID 19 infected patients with pre-existing hypercoagulable disorders have higher risk of developing thrombosis and thromboembolism and such thrombotic episodes may prove to be severely morbid in these patients. As immune-prophylaxis COVID 19 vaccines are being administered to the public. The known side effects of the COVID 19 vaccine are mild to moderate and include fever, chills, nausea, vomiting, headache, fatigue, myalgia, malaise, pain and swelling at injection site and diarrhea. Thrombosis with thrombocytopenia has been noted as a rare side effect of COVID 19 vaccine. Such side effect of COVID 19 vaccine in patients of hypercoagulable disorder may prove to be fatal. The health care workers should be cautious and judicious in managing such patients. A detailed lab profile for coagulable state of blood should be carried out in all patients COVID 19 infected patients with pre-existing hypercoagulability diseases. The patients should also be health educated regarding side effects of vaccine especially with those indicating thrombosis and they should be warranted to receive immediate medical care in case of any side effects or complications. Paucity of literature gave us an impetus to review management profile in patients of hypercoagulable disorders.

Responding to Patients' Requests for Information

1980 ◽  
Vol 1 (4) ◽  
pp. 6-8
Author(s):  
Jane L. Greenlaw
Keyword(s):  
Health Care ◽  
Informed Consent ◽  
Side Effects ◽  
Close Contact ◽  
Alternative Treatments ◽  
Recommended Treatment ◽  
Health Care Consumer ◽  
Pertinent Information ◽  
The Right ◽  
To Receive

There is little argument against the principle that the health care consumer has the right to all pertinent information regarding his condition and treatment. Nevertheless, there is resistance and patients frequently have difficulty obtaining important information.Generally, it is the responsibility of the physician to inform the patient of his diagnosis and condition, the recommended treatment, its risks and its side effects, and any alternative treatments. This is the essence of obtaining the patient's informed consent, without which treatment is illegal and unethical. An important aspect of the nurse's role is to safeguard the patient's right to receive this information, and, when necessary, to assist the patient in obtaining it. Since she is in frequent close contact with the patient, the nurse should evaluate the patient's understanding and should inform the physician when further information or clarification is needed. Furthermore, when the nurse realizes that the patient has not received or understood the necessary information, the nurse should advise the patient of his right to receive it before consenting to any treatment or procedure.

Pre-clinical evaluation of a virtual reality neuropsychological test system: Occurence of side effects

2000 ◽  
Author(s):  
Tibor I. Kesztyues ◽  
M. Mehlitz ◽  
E. Schilken ◽  
G. Weniger ◽  
S. Wolf ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Side Effects ◽  
Clinical Evaluation ◽  
Neuropsychological Test ◽  
Test System

Cutaneous ulcers following hydroxyurea therapy

Phlebologie ◽  
2004 ◽  
Vol 33 (06) ◽  
pp. 202-205 ◽  
Author(s):  
K. Hartmann ◽  
S. Nagel ◽  
T. Erichsen ◽  
E. Rabe ◽  
K. H. Grips ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Antineoplastic Agent ◽  
Limited Time ◽  
Myeloproliferative Diseases ◽  
Dermatological Side Effects ◽  
Chronic Myeloproliferative Diseases ◽  
Hydroxyurea Therapy

SummaryHydroxyurea (HU) is usually a well tolerated antineoplastic agent and is commonly used in the treatment of chronic myeloproliferative diseases. Dermatological side effects are frequently seen in patients receiving longterm HU therapy. Cutaneous ulcers have been reported occasionally.We report on four patients with cutaneous ulcers whilst on long-term hydroxyurea therapy for myeloproliferative diseases. In all patients we were able to reduce the dose, or stop HU altogether and their ulcers markedly improved. Our observations suggest that cutaneous ulcers should be considered as possible side effect of long-term HU therapy and healing of the ulcers can be achieved not only by cessation of the HU treatment, but also by reducing the dose of hydroxyurea for a limited time.

scholarly journals Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Alina Weise ◽  
Julia Lühnen ◽  
Stefanie Bühn ◽  
Felicia Steffen ◽  
Sandro Zacher ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Informed Consent ◽  
Adverse Events ◽  
Knee Arthroplasty ◽  
Evidence Based ◽  
Nocebo Effect ◽  
Legal Requirements ◽  
Consent Forms ◽  
Link Type ◽  
Total Knee

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

scholarly journals From virtual to real healing: a critical overview of the therapeutic use of virtual reality to cope with mourning

2021 ◽  
Author(s):  
Silvia Francesca Maria Pizzoli ◽  
Dario Monzani ◽  
Laura Vergani ◽  
Virginia Sanchini ◽  
Ketti Mazzocco
Keyword(s):  
Health Care ◽  
Social Media ◽  
Virtual Reality ◽  
Side Effects ◽  
Virtual Environments ◽  
Therapeutic Use ◽  
Health Care Needs ◽  
Care Needs ◽  
South Korean ◽  
Critical Overview

AbstractIn recent years, virtual reality (VR) has been effectively employed in several settings, ranging from health care needs to leisure and gaming activities. A new application of virtual stimuli appeared in social media: in the documentary ‘I met you’ from the South-Korean Munhwa Broadcasting, a mother made the experience of interacting with the avatar of the seven-year-old daughter, who died four years before. We think that this new application of virtual stimuli should open a debate on its possible implications: it represents contents related to grief, a dramatic and yet natural experience, that can have deep psychological impacts on fragile subjects put in virtual environments. In the present work, possible side-effects, as well as hypothetical therapeutical application of VR for the treatment of mourning, are discussed.

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