FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Study protocol for the effect of intraoperative subanaesthetic dose esketamine on the incidence of postoperative depressive symptoms in patients with breast cancer: a multicentre, prospective, randomised controlled trial

Por: Li · Z.-Y. · Wang · J. · Yang · J.-S. · Xu · X. · Wang · F. · Li · H.-X. · Zheng · H. · Fang · Y. · Ma · S. · Yan · T.
Introduction

Postoperative depressive symptoms are common after breast cancer surgery and can adversely affect recovery and quality of life. This multicentre trial aims to determine whether a single intraoperative subanaesthetic dose of esketamine, as an adjunct to antidepressant therapy, improves postoperative depressive outcomes at postoperative day (POD) 30.

Methods and analysis

This multicentre, prospective, randomised, triple-blind, placebo-controlled trial will enrol 824 women aged 18–80 years with stage I–III breast cancer (American Society of Anesthesiologists physical status I–III) who are scheduled to undergo surgery. Participants will be randomised 1:1 to receive 0.2 mg/kg esketamine or an equivalent volume of normal saline after anaesthesia induction and before surgical incision. The primary outcome is the incidence of depressive symptoms at POD 30, assessed using the Hospital Anxiety and Depression Scale Depression (score ≥8). Secondary outcomes include acute and chronic pain, and anxious symptoms, etc. Primary analysis will use a generalised linear mixed model with a logit link on an intention-to-treat basis.

Ethics and dissemination

The study protocol has been formally approved by the institutional ethics committee of the National Cancer Center (Approval No.25/483-5429). Written informed consent will be obtained from all participants prior to enrolment. Results will be disseminated through peer-reviewed journals and international scientific conferences.

Trial registration number

ChiCTR2600117573.

Effect of mahjong, a Chinese tiled-based game, combined with upper limb robot training on upper limb function and rehabilitation participation in Chinese stroke patients: a clinical trial protocol

Por: Xu · Y. · Wang · F. · Tan · H.-X. · Zhang · Q. · He · J. · Zhang · J. · Liu · S. · Yang · Y.
Introduction

Stroke is the second leading cause of death and disability creating a huge economic burden annually. Robot-assisted training (RT) is a promising therapy in stroke rehabilitation, but for the elderly, traditional ‘reaching objects’" tasks do not seem to create sufficient motivation, an important factor in rehabilitation, which reduces the effect of rehabilitation. Combining RT with some popular card games like mahjong, a popular tiled-based game in the Chinese elderly, is a strategy to motivate stroke survivors. Combining functional near-infrared imaging spectroscopy technique (fNIRS), the aim of this trial is to explore the effects of mahjong-based RT on stroke survivors compared with traditional RT.

Methods and analysis

The three-arm, assessor-blinded, randomised controlled trial will allocate 18 participants in each group, traditional robot-assisted training (TRT) group, mahjong game-based upper limb robot-assisted training (MULR) group and conventional rehabilitation group. Participants in these three groups will receive 30-min physical therapy and 30-min occupational therapy 5 days per week for 3 weeks. Participants in the TRT group will receive an extra 30-min TRT, while participants in the MULR group will receive an extra 30-min MULR 5 days per week for 3 weeks. The primary outcome will be the neuromuscular function of upper limb assessed by Fugl-Meyer Assessment of Upper Extremity assessed at baseline and after the last treatment has been completed. Other outcomes will include cognitive function assessed by Montreal Cognitive Assessment, rehabilitation motivation assessed by Pittsburgh Rehabilitation Participation Scale, activities of daily living assessed by Modified Barthel Index, emotion assessed by self-rating anxiety scale and self-rating depression scale) and brain neural activity assessed by fNIRS. Two-way analysis of variance, Welch’s ANOVA, post hoc comparison and simple effects analyses will be used for the analysis of scale data; while generalisation linear model analysis and seed-based correlation will be used for the analysis of fNIRS data.

Ethics and dissemination

This trial was approved by the ethics committee of the West China Hospital of Sichuan University, China (reference number: 2024298). The results of this trial will be published in peer-reviewed scientific journals.

Trial registration number

This trial has been registered on the Chinese Clinical Trial Registry, https://www.chictr.org.cn. The reference number is ChiCTR2400084049. The registered name is ‘Effect of mahjong game-based upper limb robot training on upper limb function in stroke patients: a functional near-infrared clinical study protocol’.

❌