ANZCTR search results

De-escalation skills are highly regarded by staff and patients as a tactical approach to Occupational Violence (OV) prevention and response. De-escalation refers to a range of communication techniques (non-verbal and verbal communication) to help a person (e.g. patients, consumers) regain control of their emotions (e.g. agitation, distress, frustration, anger) and assist them to calm reducing the likelihood and severity of OV by defusing emotions before they escalate to aggression or violence. This study we will evaluate a VR-based de-escalation training of Emergency Department staff.

Mother–Infant Dialectical Behaviour Therapy (MIDBT) is a specialist group programme that supports mothers with borderline personality disorder to develop skills for managing emotions and cope with the challenges of parenting. Although the programme has shown significant benefits, many mothers are unable to attend face-to-face groups because of geographical location, limited transport options or other practical barriers. This study aims to evaluate a telehealth version of the MIDBT programme and compare it with the existing face-to-face programme and a wait-list control group. The study will assess whether telehealth MIDBT improves borderline personality symptoms, depression, anxiety, post-traumatic disorder symptoms, parental stress, child social-emotional functioning and health-related quality of life. It will also explore how acceptable and practical the telehealth programme is and gather participants’ views and experiences. We predict that telehealth MIDBT will lead to greater improvements in mental health, parental stress and child social-emotional functioning compared with the wait-list group, while also being acceptable. We also expect that outcomes for telehealth MIDBT will be comparable to those achieved with the existing face-to-face MIDBT programme.

This online randomised controlled trial aims to investigate the effects of advice framing and delivery mode on participants’ intentions to use opioids for acute low back pain. Adults with current or recent (within the past three months) non-specific low back pain who have not sought medical care for this condition in the past year will complete online baseline questionnaires then be randomised to one of four intervention groups in a 2×2 factorial design: 1. Opioids “not recommended/should be avoided” + Clinician-delivered advice (n=784) 2. Opioids as a “last resort” + Clinician-delivered advice (n=784) 3. Opioids “not recommended/should be avoided” + AI-delivered advice (n=784) 4. Opioids as a “last resort” + AI-delivered advice (n=784) Participants in all groups will be given the same hypothetical case of acute low back pain and view a short intervention video corresponding to their allocated group. They will then complete a post-intervention questionnaire including questions on intention to use opioids, treatment credibility, satisfaction, and behavioural intentions. The trial will be conducted entirely online using REDCap.

This Phase 1 trial is designed to assess the safety, reactogenicity, and immunogenicity of a single IM booster dose of PVX-001 across three ascending dose levels in previously vaccinated healthy adults, in a controlled clinical setting with staged sentinel dosing and an independent Safety Review Committee. This study will be conducted in healthy women aged 18 to 64 years and healthy men aged 30 to 64 years of age.

The Chronic Conditions Course for Young Adults (CCC-YA) is an internet-delivered psychological program adapted specifically for young adults aged 18 to 29 who are living with a chronic physical health condition. This course is a modified version of the Chronic Conditions Course, and is based on cognitive behaviour therapy (CBT) principles. It is designed to help young adults understand and manage symptoms and the impacts of their condition on daily functioning and emotional wellbeing. The course includes 5 lessons, delivered over 8 weeks. The lessons are all delivered via the internet, and provide information and skills for improving emotional wellbeing and daily functioning. Participants have the option of support from a psychologist throughout the course. The primary aim is to evaluate the efficacy of this online psychological program in improving symptoms of anxiety, depression, and disability when specifically adapted for young adults with chronic health conditions. We hypothesise that the program will result in significant improvements in anxiety, depression, and disability at the completion of treatment.

Brief description of the study purpose This study aims to investigate whether self-guided use of sensory massage balls is a feasible, safe and effective way to reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as numbness, tingling, pain and weakness, and to improve quality of life for people affected by CIPN. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older who are receiving chemotherapy or have completed chemotherapy within the previous month, are receiving care through Tweed Valley Hospital, and have symptoms consistent with chemotherapy-induced peripheral neuropathy. Study details Eligible participants will be randomly assigned to one of two groups. One group will receive a set of sensory massage balls and instructions for daily self-guided use at home for 8 weeks, while the other group will receive usual care in the form of publicly available physical activity guidance. After completing Week 8 assessments, participants in the usual care group will also receive the massage ball set if no intervention-related safety concerns are identified. Participants will attend study assessments at baseline, Week 8 and Week 16. During the intervention period, participants using the massage balls will record their usage and symptoms in a daily logbook and receive an initial face-to-face training session. Study assessments will evaluate neuropathy severity, quality of life, balance, strength and hand dexterity. It is hoped that the results of this pilot study will inform larger future clinical trials and contribute to the development of supportive care strategies for people experiencing chemotherapy-induced peripheral neuropathy.

Hip pain is common and can make it difficult for people to participate in physical activity and everyday activities. This study aims to determine whether a 12-week physiotherapist-led graded activity modification program is feasible for adults with hip-related pain. Participants will complete two face-to-face clinical assessments and participate in five individual physiotherapy consultations delivered via telehealth. The program will gradually modify and progress physical activity based on each participant's symptoms and goals. Throughout the study, participants will complete online questionnaires and provide information about their symptoms, physical activity, and study experience. The findings will determine whether a larger randomised controlled trial should be undertaken to evaluate the effectiveness of this intervention for people with hip-related pain.

Many people who have shoulder stabilisation surgery do not return to their previous level of sport or activity, and current rehabilitation programs may be overly conservative. This pilot randomised controlled trial compares two physiotherapy rehabilitation programs in adults aged 16–40 following arthroscopic Bankart repair surgery: a standard time-based program (the American Society of Shoulder and Elbow Therapists, or ASSET, guideline) and a new criterion-based program called RISE (Rehabilitation for Instability with Structured Elements), which progresses based on individual recovery milestones rather than fixed timeframes. Participants will be randomly assigned to one of the two programs and followed up for six months, with shoulder function, strength, range of motion, pain, and psychological readiness assessed by an independent assessor. We hypothesise that the RISE program will result in greater shoulder function at six months without compromising safety. The findings will assess the feasibility of a larger trial and inform the design of a future definitive randomised controlled trial comparing the two approaches.

The aim of this study is to test if Physta® can improve hormone profiles, body composition and muscular strength in middle-aged men. It is hypothesised Physta® will increase total testosterone (and associated hormones), muscular strength, fat free mass and decrease fat mass in middle-age men compared to men who use a placebo.

The main aim of this study is to find out whether starting a specialised pain relief treatment early,using a local anaesthetic delivered continuously through a small catheter near the nerves around the ribs,provides better pain control and improves recovery for people aged 65 years and older who have multiple rib fractures on one side of the chest. The study will compare these patients with a similar group who receive standard pain management using medications alone (such as tablets or injections), without any nerve-blocking procedures. The results will help identify the most effective way to manage pain in older patients with rib fractures. The goal is to reduce side effects from pain medications, improve recovery and overall health outcomes, and guide healthcare professionals in choosing the best pain management approach for this patient group.