Drop-out from chronic pain treatment programmes: Is randomization justified in biopsychosocial approaches?

Bicego, Aminata Yasmina; Monseur, Justine; Rousseaux, Floriane; Faymonville, Marie-Élisabeth; Malaise, Nicole; Salamun, Irène; Collinet, Alain; Nyssen, Anne‐Sophie; Vanhaudenhuyse, Audrey

doi:10.2340/16501977-2824

Cited by 13 publications

(20 citation statements)

References 39 publications

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“…Standardisation of the techniques did not allow an adaptation to the patient situation. 37 In our study, we used one design of ‘passive VR’ with no interactions and no user's control of the environment. Users’ interactions with the virtual reality environment and possibility of action (e.g.…”

Section: Discussionmentioning

confidence: 99%

Virtual reality and hypnosis for anxiety and pain management in intensive care units

Rousseaux

Dardenne²,

Massion³

et al. 2021

European Journal of Anaesthesiology

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BACKGROUND Virtual reality and hypnosis are little studied in complex contexts, such as intensive care, where patients need significant physical and psychological assistance. OBJECTIVES To compare and combine hypnosis and virtual reality benefits on anxiety and pain on patients before and after cardiac surgery. DESIGN Prospective randomised controlled clinical trial. SETTING The study was conducted in the University Hospital of Liege (Belgium) from October 2018 to January 2020. PATIENTS One hundred patients (66 ± 11.5 years; 24 women, 76 men) were included. Participants were adults undergoing cardiac surgery. Exclusion criteria: psychiatric diseases, claustrophobia, acrophobia, hearing loss, visual impairment, extreme fatigue, confusion surgery cancelled. INTERVENTIONS Patients were randomly assigned to four arms (control; hypnosis; virtual reality; virtual reality hypnosis) and had 20 min of one of the techniques the day before and the day after surgery. MAIN OUTCOMES MEASURES Anxiety, pain, fatigue, relaxation, physiological parameters, and opioid use were evaluated before and after each session. RESULTS The main results did not show any significant differences between the groups. In all groups, anxiety decreased and pain increased from baseline to the postoperative day. Relaxation increased in all groups in the pre-operative ( P < 0.0001) and postoperative period ( P = 0.03). There were no significant differences for fatigue, physiological measures, or opioid use. CONCLUSION As there were no significant differences between groups for the measured variables, we cannot affirm that one technique is better than another. Additional studies are required to compare and evaluate the cost-effectiveness of these techniques for critical care patients and caregivers. TRIAL REGISTRATION ClinicalTrials.gov: NCT03820700. https://clinicaltrials.gov/ct2/show/NCT03820700 . Retrospectively registered on 29 January 2019.

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Section: Discussionmentioning

confidence: 99%

Virtual reality and hypnosis for anxiety and pain management in intensive care units

Rousseaux

Dardenne²,

Massion³

et al. 2021

European Journal of Anaesthesiology

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“…Thus, applying the ITT technique rendered our analyses robust but could not reveal a group effect because too many patients maintained the same score (sometimes the T1 score) over the 4 time points. Furthermore, in another study [58] we demonstrated that the delayed onset of treatments (� 4 months) and randomization significantly increased the risk of never starting the treatments. These results urged us to rethink the accuracy of only relying on randomized control trials to evaluate the effectiveness of complementary approaches.…”

Section: Plos Onementioning

confidence: 82%

Complementary treatment comparison for chronic pain management: A randomized longitudinal study

Bicego

Monseur

Collinet³

et al. 2021

PLoS ONE

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Background In chronic pain, it seems that the effect of cognitive-behavioral therapy (CBT) is boosted when it is combined with hypnosis. The aim of this study was to assess the efficacy of self-hypnosis combined with self-care (i.e., a type of CBT) compared to music/self-care, self-care and psychoeducation/CBT and to evaluate their long-term effects. Methods An open label randomized clinical trial enrolled patients with chronic pain and was carried out at the University Hospital of Liège (Belgium). Patients were randomized into four groups: self-hypnosis/self-care, music/self-care, self-care, psychoeducation/CBT (7 monthly sessions of 2 hours). Two follow-up sessions were delivered at 6- and 12-month. Levels of pain, fatigue intensity, anxiety, depression, insomnia severity, disability, health locus of control, mental and physical quality of life and attitudes (control, disability, harm, emotion, medical cure, medication, solicitude) towards pain were assessed before and after the treatments, and at follow-up. Results 203 patients were randomized: 52 in self-hypnosis/self-care, 59 in music/self-care, 47 in self-care, and 45 in psychoeducation/CBT. No group effect was found. A significant time effect was showed. Directly after the treatment, all groups decreased in pain attitudes and physical quality of life. Perceived control increased. At 6-month, all patients kept their levels of physical quality of life and perceived control, and showed decrease in pain intensity, harm, emotion and medical cure. At 12-month, scores that had change previously remained ameliorated, a decrease in insomnia severity and an increase in internal locus of control were observed. Conclusions The present findings are encouraging as they display long-term beneficial effects of complementary biopsychosocial-based treatments in chronic pain. It seems that patients continued to apply the learnt strategies as improvements were observed one year after the treatments had ended.

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“…This preference-based design was chosen because we did not find it relevant for a patient who wants to participate, for example, in the hypnosis intervention to be obliged to participate in another intervention. Indeed, patients who can chose their treatment have more motivation and a greater adherence ( King et al, 2005 ; Preference Collaborative Review Group, 2008 ; Sedgwick, 2013 ; Bicego et al, 2021a ). We also chose this design based on our clinical observations.…”

Section: Discussionmentioning

confidence: 99%

“…We designed a longitudinal controlled superiority trial (see Figure 1 ) with 160 patients with cancer who will choose between four conditions (see section “Recruitment” for sample size calculation): hypnosis-based group intervention, MSC meditation-based group intervention, SICT-based group intervention, or a control group. This kind of design has been chosen because patients who receive their preferred therapeutic option seem to be more motivated and exhibit greater adherence to the treatment ( King et al, 2005 ; Preference Collaborative Review Group, 2008 ; Sedgwick, 2013 ; Bicego et al, 2021a ). Indeed, preference-based trials are increasingly developed as researchers often want to know if an intervention is effective for the participants who choose it, rather than determining the best treatment option irrespective of the participant’s choice ( Kowalski and Mrdjenovich, 2013 ).…”

Section: Methods and Analysismentioning

confidence: 99%

Hypnosis, Meditation, and Self-Induced Cognitive Trance to Improve Post-treatment Oncological Patients’ Quality of Life: Study Protocol

Grégoire

Marie

Sombrun³

et al. 2022

Front. Psychol.

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IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue (CRF), emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations (e.g., small sample size, no control group, and no follow-up). Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive trance (SICT). It seems to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions (hypnosis, meditation, and SICT) to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties (primary outcomes).Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate (hypnosis, mindful self-compassion meditation, SICT, or no intervention—control group). To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study (baseline); immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/ (NCT04873661). Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661

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Drop-out from chronic pain treatment programmes: Is randomization justified in biopsychosocial approaches?

Cited by 13 publications

References 39 publications

Virtual reality and hypnosis for anxiety and pain management in intensive care units

Virtual reality and hypnosis for anxiety and pain management in intensive care units

Complementary treatment comparison for chronic pain management: A randomized longitudinal study

Hypnosis, Meditation, and Self-Induced Cognitive Trance to Improve Post-treatment Oncological Patients’ Quality of Life: Study Protocol

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