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NCT ID: NCT06257186 Recruiting - Anxiety Clinical Trials

Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study

Start date: November 2, 2023
Phase: N/A
Study type: Interventional

Childbirth is a multifaceted experience and could involve both positive and negative feelings. Feelings of limited capability in the face of childbirth may result in a condition termed as Fear of Childbirth (FOC), which contributes to significantly higher risks of birth complications resulting in psychological trauma. This study aims to examine the effects of Art Therapy (AT) on FOC, perceived maternal parental self-efficacy, postpartum maternal infant bonding and postpartum depression. A mixed-methods sequential explanatory design will be used. Phase one will adopt a quasi-experimental study design. Women who are aged 21 and above, English literate and having a singleton pregnancy will be approached to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be considered as having FOC and will be invited to participate in the AT intervention. Participants who are agreeable to receive AT will be recruited in the experimental group. Participants who declined to participate in AT will receive routine antenatal care (control group). Outcomes that will be measured in both groups include perceived maternal self-efficacy, maternal infant bonding, and maternal depression after childbirth. A qualitative descriptive design will be used in phase two. Semi-structured interviews will be conducted with the participants to explore their experiences of the AT. Descriptive analysis, independent sample t-test, paired sample t-test, and regression analysis will be used for analysis of the quantitative data in phase one. Qualitative data from phase two will be analysed using thematic analysis. Findings of this study may provide evidence on the use of AT to cope with FOC during pregnancy. If proven to be beneficial, AT may potentially be introduced and advocated as an intervention for women with FOC.

NCT ID: NCT06247371 Recruiting - Heart Failure Clinical Trials

Impact of a Novel Heart Failure Medication Decision Aid

Start date: March 2024
Phase: N/A
Study type: Interventional

A modified Zelen design randomised controlled trial over 6 months period is designed to investigate the influence of a heart failure medication decision aid prior to clinic session on shared decision making and its long term effect. Participants are randomised to either the decision aid arm or the usual care arm.

NCT ID: NCT06241573 Recruiting - Clinical trials for Hidradenitis Suppurativa (HS)

A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

Start date: April 16, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100). The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks. Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.

NCT ID: NCT06236191 Recruiting - Insomnia Clinical Trials

Improving Sleep of Children With Neurodevelopmental Disorders: Pulsed Current Stimulation Versus Melatonin

Start date: July 24, 2023
Phase: N/A
Study type: Interventional

This is a prospective, randomised controlled trial that evaluates whether transcranial pulsed current stimulation increased total sleep time in children with neuroevelopmental disorder, compared to Melatonin

NCT ID: NCT06228638 Recruiting - Memory Impairment Clinical Trials

CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)

CONNECT
Start date: December 12, 2023
Phase:
Study type: Observational [Patient Registry]

This is an observational, prospective cohort of patients who were prescribed or have taken CognivAiD as prescribed by the attending physician. The safety and efficacy of CognivAiD have been established in clinical studies. The registry will assess the safe use and effectiveness of CognivAiD in a real-world setting. The registry is designed as a product registry in clinical practice. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies during follow-up, use of multiple products in combination or sequence, different dosing, and compliance).

NCT ID: NCT06225037 Recruiting - Anesthesia Clinical Trials

EEG-guided Propofol Sedation Versus Standard Care for Oesophagogastroduodenoscopy and Colonoscopy in Children

EPOC
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare electroencephalogram (EEG) guided propofol sedation versus standard care in paediatric patients aged 6-16 undergoing oesophagogastroduodenoscopy and colonoscopy. The main questions it aims to answer are whether EEG guided propofol sedation will result in: - faster wake up time - reduced time to discharge - reduced cumulative propofol dosage - lower incidence of intraoperative adverse events - no difference in intraoperative undesirable movement - lower incidence and severity of emergence delirium - lower intraoperative depth of sedation Participants will wear an EEG sensor (Sedline) prior to undergoing propofol sedation until they wake up post procedure.

NCT ID: NCT06219941 Recruiting - Gastric Cancer Clinical Trials

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Start date: December 13, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.

NCT ID: NCT06214520 Recruiting - Clinical trials for Diabetes Mellitus Type 2

App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management

EmpowerPlus
Start date: February 23, 2024
Phase: N/A
Study type: Interventional

There is an urgent need for better control and prevention of complications in type 2 diabetes mellitus (T2DM). Behavioural change is critical, and while literature suggests that motivational interviewing (MI) may be effective in improving glycemic control, none has explored app-based MI designed specifically for T2DM. The overall objective of this project is to determine the effectiveness of primary care model combining app-based MI and AI-powered personalised nudges delivered through a mobile application (app) for diabetes management (EMPOWER-PLUS). The project aims to evaluate the effectiveness and implementation of MI and nudges through EMPOWERPLUS to deliver diabetes management through a randomised controlled trial (RCT). This will be a 3-arm RCT with primary outcome measure being the difference in HbA1c level at week 36 between the intervention and control arms. Secondary outcome measures include cost-effectiveness, quality of life, medication adherence, diet, and physical activity. Eligible poorly controlled T2DM patients with T2DM in polyclinics will be randomized to intervention arm who will receive EMPOWER-PLUS and smartwatch wearable on top of their usual clinical care. The first control group will have access to nudges delivered through app and smartwatch wearable in addition to usual clinical care but will not receive MI. The second control group will receive usual care (no access to MI, nudges and smartwatch wearable). This study is important to improve T2DM outcomes and reduce healthcare utilization by providing scientifically evaluated and transformative primary care model. Leveraging on digital technology and artificial intelligence to drive personalised care, behavioural change and empowerment has huge potential for scale up.

NCT ID: NCT06205303 Recruiting - Hypothyroidism Clinical Trials

Interventional Study to Improve Medication Adherence Using Patient Decision Aid

IMPART
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

Background: Although hypothyroidism is easily treated with levothyroxine (LT4) replacement, results from several studies indicate that people receiving LT4 replacement often have under- or over-replaced thyroid function. Poor medication adherence and factors interfering with thyroxine absorption and bioavailability may result in such under-replacement. Using the COM-B (Capability, Motivation, and Opportunity - Behavior) model, a health education intervention using patient decision aid (PDA), was developed for primary care physicians to educate individuals about thyroxine replacement. Besides imparting health literacy, PDAs provide greater comfort of the patients to participate in decision making. Intervention with the PDA aims to improve the medication adherence by increasing patients' knowledge about thyroxine replacement. Specific aims: The primary aim is to determine effectiveness of PDA in improving the knowledge, medication adherence and quality of life of the under-replaced hypothyroid adults in a primary care setting. Secondary aims are to explore their understanding and acceptance on the PDA and to assess their perceived usability of this PDA. Methodology: A randomised controlled trial will be conducted at SingHealth Polyclinics (SHP) using mixed-method study design to determine effectiveness of PDA. Patient participants will be randomly allocated in a 1:1 ratio to either the intervention or control group. A total of 236 (118 in each group) patient participants will be enrolled by simple randomization. Eligible patient must be of age ≥21 years years and have LT4 under-replacement with Thyroid stimulating hormone (TSH) >3.7 mIU/L within the last 6 months. Relevance/significance of the study: Findings from the study may add evidence to the scientific knowledge of using PDA to improve medication adherence and recommend development of similar interventions for other chronic medical conditions.

NCT ID: NCT06202677 Recruiting - Clinical trials for Obsessive-Compulsive Disorder

Effectiveness of a Self-guided Mobile Application in Improving Obsessive Compulsive Disorder Symptoms

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Obsessive Compulsive Disorder (OCD) is a significant mental health problem worldwide. OCD typically begins in young adulthood, and without adequate intervention, often takes a chronic course. Individuals with OCD may suffer impaired relationships, and ability to engage in leisure activities, study or work. Thus, prevention efforts are crucial to target OCD symptoms before they worsen. The goal of this randomized-controlled trial (RCT) is to evaluate the effectiveness of a self-guided OCD program on a mobile phone application in young adults with subclinical OCD symptoms. Hypothesis 1a: The intervention group will report significantly lower OCD symptoms (primary measure) at post-intervention and 1-month follow-up compared to the control group. Hypothesis 1b. The intervention group will report significantly lower depression, anxiety and stress symptoms (secondary measure) at post-intervention and 1-month follow-up compared to the control group. Hypothesis 2. Perfectionism will moderate the expected relationship between the OCD intervention and the reduction of scores on both primary and secondary measures, i.e. individuals with lower levels of perfectionism will benefit more from the OCD intervention than those with higher levels of perfectionism.