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Daily low-dose aspirin does not appear to reduce risk of fractures—but may increase the risk of serious falls—among healthy older people living in the community, according to a substudy of the ASPREE (Aspirin in Reducing Events in the Elderly) clinical trial.
Studio, “il gentil sesso recupera però più rapidamente”
Introduction
Family members who care for elderly people experience high levels of chronic stress because of the intensive assistance they provide permanently to those who are losing their autonomy. Often considered a burden, this stress causes serious consequences to their health and worsens their quality of life (QoL). Reducing caregivers’ chronic stress via self-hypnosis protocols may be an effective treatment. The objective is to evaluate the feasibility and acceptance of self-hypnosis protocols taught by hypnotherapy-trained nurses to reduce the chronic stress of in-family caregivers.
Methods and analysis
This study is a prospective, monocentric, non-blinded, parallel, pilot, randomised waitlist-controlled trial that will be conducted at the University Hospital of Reunion Island. Sixty participants will be randomly allocated to one of two groups: a self-hypnosis group (intervention) or a waitlist control group. After an 8-week training programme, intervention participants will practice self-hypnosis for ten minutes/day over 8 weeks and subsequently be followed up for 16 weeks thereafter. The primary outcome is to assess the feasibility of a 16-week self-hypnosis protocol for in-family caregivers. Secondary outcomes include the evaluation of the effects of practising self-hypnosis among in-family caregivers of elderly people concerning their stress levels, sleep disorders, levels of fatigue, and QoL at 2, 4 and 8 months on an exploratory basis.
Ethics and dissemination
Ethics approval was obtained from the Institutional Ethics Committee CPP Ile de France VI—Groupe Hospitalier Pitié Salpêtrière on 14 April 2021 (ID RCB: 2021-A00009-32). All participants will receive information about the trial in verbal and written forms. They will give an oral consent which is notified in a dedicated research file prior before enrolment. Results will be published in peer-reviewed journals as well as presented and disseminated at conferences.
Trial registration number
NCT04909970.
Circulation, Volume 147, Issue 1, Page e1-e3, January 3, 2023.
This Medical News feature examines how the expiration of states’ pandemic-related licensure waivers is limiting telemedicine services.
Background
Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduces opioid consumption and prevents PONV. Although several studies have been conducted on AAA, its safety and efficacy in AF catheter ablation remain unclear due to small sample sizes and a paucity of methodologically rigorous designs. Therefore, this trial was designed to evaluate the safety and efficacy of AAA in reducing PONV and morphine hydrochloride consumption during catheter ablation.
Methods
This single-centre, patient-blinded, randomised, non-penetrating sham-controlled trial will be conducted in China. A total of 100 patients will be randomly assigned to the AAA and conventional anaesthesia (CA) groups in a ratio of 1:1. The patients will receive AAA or CA plus sham acupuncture during catheter ablation and will be followed up for 30 days. The primary outcomes include the total amount of morphine hydrochloride consumed during catheter ablation and PONV within the first 24 hours after the procedure. The secondary outcomes include pain, nausea and vomiting, anxiety, patient’s ability to cope during catheter ablation, AF recurrence and quality of life, as assessed using the numeric rating scale. Adverse events will be recorded and their influence will be analysed at the end of the trial.
Discussion
This study will help in evaluating the safety and efficacy of AAA applied for AF catheter ablation in reducing opioid doses during the procedure and the occurrence of PONV.
Ethics and dissemination
The study has been approved by the Medical Ethics Committee of Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The results of the study will be published in peer-reviewed journals and presented at conferences if possible.
Trial registration number
ChiCTR 2100042646; Chinese Clinical Trial Registry.
New England Journal of Medicine, Ahead of Print.
Annals of Internal Medicine, Volume 175, Issue 12, Page JC140, December 2022.
Annals of Internal Medicine, Volume 175, Issue 12, Page JC139, December 2022.
Annals of Internal Medicine, Volume 175, Issue 12, Page JC134, December 2022.
Annals of Internal Medicine, Volume 175, Issue 12, Page JC135, December 2022.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
