Clinical Research Directory

Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors

The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) combined with a working-memory task can treat chronic pain and related emotional and cognitive problems after chemotherapy in adult cancer survivors. tDCS is a non-invasive and painless technique that uses a very weak electrical current, applied through two small electrodes on the head, to modulate the activity of certain brain areas. The main questions it aims to answer are: * Does tDCS reduce chronic pain intensity after chemotherapy in cancer survivors? * Does tDCS also reduce anxiety, depression, and cognitive problems, and improve the regulation of cortisol, a stress-related hormone? * Are the effects on pain, anxiety, depression, cognitive problems, and cortisol sustained when treatment continues with a maintenance phase of up to 2 months? Researchers will compare real tDCS to sham (placebo) tDCS, a look-alike procedure that does not deliver effective stimulation, to see if real tDCS works to reduce pain and improve these symptoms. Participants will: * Receive real or sham tDCS (assigned by chance) in 5 daily sessions over 1 week. Each session lasts 20 minutes: 10 minutes at rest and 10 minutes while doing a working-memory task * If they did not respond to sham tDCS, be offered 5 additional daily sessions of real tDCS * If they respond to treatment, continue with real tDCS twice a week for up to 2 months * Complete assessments of pain, mood, memory, attention, and quality of life before treatment, after each phase, and during and at the end of the maintenance phase * Collect saliva samples to measure cortisol

Virtual Reality-Assisted Nursing Intervention During Intrauterine Device Insertion

This randomized controlled trial evaluated the effects of a virtual reality-supported nursing intervention based on Kolcaba's Comfort Theory on women's comfort, emotional state, pain and physiological parameters during intrauterine device insertion. Seventy women attending a family planning clinic were individually randomized by lottery to a virtual reality group, who received the intervention in addition to routine care, or to a control group, who received routine care only.

The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery

This randomized controlled trial aims to investigate the effects of virtual reality headset use on pain, anxiety, patient satisfaction, and physiological parameters in patients undergoing open-heart surgery. Participants will be randomly assigned to two groups: the virtual reality group and the control group. Pain levels, anxiety levels, satisfaction levels, and physiological parameters will be assessed both before and after the procedure. The study aims to determine whether this non-pharmacological method improves postoperative pain, anxiety, patient satisfaction, and physiological parameters.

The Effect of ShotBlocker on Symptoms of Pain, Anxiety, and Cortisol Hormone Levels

The aim of this study is to evaluate the effect of Shotblocker, administered during lumbar puncture, on patients' pain levels, anxiety levels, and cortisol levels (a physiological stress indicator). This randomized controlled trial aims to scientifically demonstrate the effectiveness of Shotblocker use in reducing pain and anxiety during and after the procedure, and its effect on the stress response, compared to standard practice.

Aromatherapy in Total Knee Replacement

The purpose of this pilot randomized controlled trial is to investigate the effects of aromatherapy on postoperative anxiety and pain in total knee replacement patients. The primary research questions are: Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo? Participants will be assigned to one of the following groups at random: * Intervention: Aromatherapy with the lavender-peppermint scent * Control: Aromatherapy with the almond oil scent Participants will also be asked to complete pre- and post-operative questionnaires. Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety and/or pain.

AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)

This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss

This study will examine whether virtual reality can reduce pain and anxiety in women undergoing surgical uterine evacuation after early pregnancy loss at Tarsus State Hospital, Türkiye. Ninety women will be randomly assigned to two groups of 45 participants each. One group will receive virtual reality in addition to routine care, while the other group will receive routine care alone. Researchers will compare pain, anxiety, and vital signs between the groups to assess the effects of virtual reality.

Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents

This study evaluates the effectiveness of the Wellbeing Course for New and Expecting Parents (WCNEP), an internet-delivered cognitive behavioral therapy (ICBT) intervention, in reducing symptoms of anxiety and depression in perinatal parents, within a routine care online therapy clinic (the Online Therapy Unit). The study aims to assess treatment uptake, perceptions, feasibility, and effectiveness of the WCNEP in routine care among birthing and non-birthing parents. Over the duration of 8 weeks, participants will review course materials online and respond to questionnaires aimed at assessing changes in various outcomes over time.

Effects of Xiangshao Granules on Anxiety in Menopausal Women.

Symptoms of anxiety are prevalent during the menopausal transition and early postmenopause. These symptoms are mainly improved by anti-anxiety agents, which are associated with some adverse effects including dizziness, sleepiness, and constipation and not all patients respond to currently available pharmacological treatments, thus novel agents with fewer side effects are needed. Some studies have shown that traditional Chinese medicine can alleviate menopausal symptoms safely and economically, and improve quality of life. Xiangshao granules reportedly have good curative effects on menopausal symptoms and premenstrual syndrome and exhibit good safety. This study aim to evaluate the efficacy and safety of Xiangshao granule in improving anxiety state of women with menopause syndrome.

Feasibility and Acceptability of an E-learning Dialectical Behavior Therapy Skills Course

Dialectical behavior therapy (DBT) is a comprehensive, third-wave psychological intervention designed for patients with complex and severe behavioral, emotional, and interpersonal dysfunction. DBT has since been adapted to shorter, briefer, "skills training" formats, which have been effective for a number of mild-to-moderate mental health conditions, including depression and anxiety. Moreover, internet-delivered formats of DBT (iDBT) have similarly started to build support for their effectiveness, although there are fewer studies on digital formats. One study found that over 12 weeks, iDBT was deemed acceptable (e.g., 50% of participants were still active after 4 weeks) and there were improvements in multiple symptom domains, such as depression, anxiety, suicidality, functional disability, as well as alcohol and substance dependence. In the current study, the investigators will examine the feasibility, acceptability, and potential efficacy of a new iDBT intervention, packaged as an online e-learning skills course, with adult participants. The study is a pilot trial as iDBT has never been tested in this format through formal research. Thus, this pilot study aims to examine whether this course is usable, practical, and potentially useful to others in the future. The investigators will recruit up to 40 individuals with mild-to-moderate depression and anxiety for an 8-week study. Following a phone screen to determine eligibility, participants will complete a baseline session where they will provide consent, complete a brief interview and questionnaires, and register for the e-learning skills course. Over the course of 8 weeks, participants will be exposed to material adapted from a DBT manual in a self-guided manner. Participants will complete follow-up assessments at 4 and 8 weeks.

Adverse Adolescent Pathways to Substance Use

Purpose: This 5-year R01 study will elucidate the role of maturational change across adolescence in neural connectivity and physiological stress responses in the relationship between anxiety and adverse pathways to substance use (APSU). Participants: Children (N=200) aged 12-14 with symptoms of anxiety and their legal caregiver will be recruited from clinical and community sources. Procedures: Youth participants will complete several questionnaires and interviews, undergo neuroimaging while performing cognitive tasks, and have their heart rate and skin conductance monitored during a mildly stressful task. Caregivers will complete several questionnaires.

Video-Based Preoperative Education for Anxiety in Patients Undergoing Anal Fistula Surgery

This study evaluated whether video-based education before surgery could reduce anxiety and improve early recovery in patients undergoing anal fistula surgery under spinal anesthesia. A total of 72 adult patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups. The intervention group received standard preoperative information and watched an approximately 8-minute educational video explaining spinal anesthesia, the surgical procedure, pain management, and early postoperative recovery. The control group received standard verbal and written information only. The main objective was to determine whether video-based education reduced anxiety immediately before surgery, measured using the State-Trait Anxiety Inventory (STAI-S). The study also evaluated other outcomes, including anxiety measured using another questionnaire (APAIS), postoperative pain, pain medication requirements, and patients' willingness to undergo spinal anesthesia again. The study aimed to investigate whether adding a short educational video to routine preoperative counseling could improve patients' psychological preparation and early perioperative experience.

High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety

The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are: Does 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation? Does 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation? Researchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity. Participants will: Undergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC; Have continuous electrocardiography (ECG) recordings collected during the entire stimulation session; Complete clinical and psychiatric assessments before participation.

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements. The primary outcome is pain at energy level 900 during ESWL for the intervention and the control group. The secondary outcomes are as follows: * Type and dose of analgesia * Conductance scores/values * Anxiety levels * Patient satisfaction * Procedure duration * Adverse events Participants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not

Effects of Qigong Exercise on Anxiety and Depression in Patients Receiving Inpatient Treatment for Substance Use Disorder

Patients receiving inpatient treatment for substance use disorder may experience anxiety and depressive symptoms. Qigong is a mind-body exercise that combines gentle movements, breathing techniques, and relaxation. This study aimed to evaluate the effects of Qigong exercises on anxiety and depression levels. The study was conducted as a single-blind, randomized controlled trial. Patients meeting the predefined eligibility criteria were randomly assigned to either the intervention group or the control group. The intervention group participated in Shibashi Qigong exercises four times a week for three weeks (12 sessions in total), while the control group did not receive Qigong exercises. Both groups continued their usual treatments. Anxiety and depression levels were assessed using the State-Trait Anxiety Inventory (STAI) and the Beck Depression Inventory (BDI) at three time points: before the intervention, immediately after the three-week exercise program, and one week after its completion.

Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination

The purpose of this study is to evaluate whether a brief standardized reflexology session administered before the first pelvic examination reduces maternal state anxiety among term pregnant women admitted for induction of labor. The study is a prospective, randomized, controlled trial comparing a 15-minute reflexology session with a 15-minute rest period before pelvic examination. Anxiety, pain during the examination, patient satisfaction, blood pressure, and heart rate will be assessed.

Psychological and Physiological Effects of Three-Minute Breathing Space Meditation in UPM Postgraduate Students

Postgraduate students often experience psychological distress linked to academic demands, deadlines, research uncertainty, and financial or social pressures, and international students may face additional adjustment challenges. This study tests whether a brief, low-burden mindfulness practice - a three-minute Breathing Space Meditation (BSM) session, done four days a week for 8 weeks - can reduce stress, anxiety, and depression in postgraduate students at Universiti Putra Malaysia, compared with an active control activity that is matched in format and contact time but does not involve mindfulness training. Participants are randomly assigned to one of the two groups and are grouped by whether they are local or international students. The study also looks at whether the intervention affects stress hormone (cortisol) levels, a marker of inflammation (C-reactive protein), and a brain-wave measure linked to mood, and it collects brief daily check-ins on mood, stress, sleep, and academic pressures over the 8 weeks.

Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students

This study tests whether reading a structured self-help book (bibliotherapy) can reduce anxiety, depression and stress and change unhelpful thinking patterns in medical and health-sciences students. Students in health programs face heavy academic and clinical demands and are at increased risk of emotional distress. A thinking style called the Cognitive Attentional Syndrome (worry, rumination, threat monitoring and unhelpful coping) is thought to link stress to anxiety and depression. Metacognitive therapy targets this thinking style, and low-intensity self-help books may make these principles accessible to students. A total of 165 students at İstanbul Nişantaşı University will be randomly assigned to one of three groups: two groups each receive a different self-help book and read it at their own pace over 8 weeks, and the third group (waitlist) receives the books after the study ends. All participants complete short online questionnaires (DASS-21, CAS-1, MCQ-30) at the start, at week 4 and at week 8, and receive brief telephone calls at weeks 2, 4 and 6 to confirm participation.

Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section

This study will examine whether virtual reality during planned cesarean birth reduces women's anxiety and improves their satisfaction with the birth experience. The study will include 144 women undergoing elective cesarean section under spinal anesthesia at Adana City Training and Research Hospital in Türkiye. Participants will be randomly assigned to one of two groups. One group will receive routine care and watch a relaxing nature video with natural sounds through a virtual reality headset during surgery. The other group will receive routine care alone. Virtual reality will be paused when the baby is born so that anxiety can be assessed and the mother can see her baby. It will then resume until surgery ends. Anxiety and vital signs will be assessed before surgery and 15-30 minutes after completion of surgery, once the participant is clinically stable. An additional brief anxiety assessment will be performed immediately after birth, before the mother first sees her baby. Satisfaction with cesarean birth will be assessed 6-8 hours after birth. The researchers will compare the results between the two groups to evaluate the effects of virtual reality on maternal anxiety and cesarean birth satisfaction.

Characterization of Emotional Response Profiles Triggered by a Digital Artwork of Musicalized Impressionist Paintings

Global warming, progressing at a rapid pace in Canada, is causing severe consequences for ecosystems and human health. Rising temperatures accelerate glacier melting, increase heat waves, and disrupt biodiversity. These environmental changes impact mental health, notably through ecoanxiety, a form of anxiety linked to climate change. Although ecoanxiety is a natural reaction to environmental degradation, it can lead to chronic stress, generalized anxiety, and even depression. Recent studies show that ecoanxiety is increasingly common, especially among young people. In Quebec, 73% of young adults (18-35 years) report experiencing ecoanxiety, with 42% experiencing significant levels. Vulnerable populations, such as Indigenous communities like the Inuit of Nunavik, are particularly affected. To address ecoanxiety, interventions focused on emotional management and reconnecting with nature are essential. Studies show that outdoor activities such as walking or gardening reduce negative emotions and improve well-being by fostering a connection with nature, thereby increasing resilience to climate change. Art, especially pictorial art, is emerging as a promising tool in combating ecoanxiety. The World Health Organization (WHO) recognizes the mental health benefits of art, which is not only beneficial for those suffering from mental illness but also for the general population. The Quebec Interministerial Mental Health Action Plan (PAISM) 2022-2026 highlights the promotion of art as a priority in mental health prevention. Among art forms, the contemplation of Impressionist paintings has shown positive effects, generating emotions of serenity and deeper reflection on our relationship with nature. Music therapy also plays a vital role in anxiety management, promoting relaxation and emotional expression. Music, in particular, has shown promise in reducing ecoanxiety. Listening to music can alleviate anxiety and depression by stimulating the limbic system, which regulates emotions. Music can also modulate physiological stress responses and strengthen personal resilience, enhancing emotional regulation in environmental crises. An innovative approach involves creating music from electrophysiological signals captured from plants, a process known as sonification. This nature-inspired music fosters a deeper connection with the environment, potentially reducing ecoanxiety and increasing resilience. Emotions, both positive and negative, are central to mental health. According to James Russell\'s circumplex theory of emotions, they are classified into two dimensions: valence (pleasant or unpleasant) and arousal (energy level). Positive emotions like joy and relaxation promote well-being, while negative emotions, such as anxiety and sadness, have detrimental effects on mental health. Emotional responses manifest through physiological changes, such as increased heart rate and skin conductance. Modern technologies, like functional MRI, allow researchers to observe the brain\'s activity in areas like the amygdala, responsible for emotional regulation. Digital technologies have revolutionized the use of art in promoting mental health. Immersive digital interventions, such as apps that allow users to experience art online, have shown positive results. One such app currently in development combines the works of Impressionist painters Claude Monet and Helen McNicoll with music created from plant electrophysiological signals. This digital combination of art and nature offers emotional benefits, promoting well-being in the face of climate challenges. It is well-established that positive emotions play a crucial role in improving mental health and protecting against ecoanxiety. Research shows that Impressionist paintings and music can generate positive emotions. This study hypothesizes that (1) observing and listening to musicalized paintings can generate positive emotions, (2) the emotional effect is stronger when both stimuli are combined, and (3) these emotions vary with age.

Psilocybin FCR Early-Stage Breast Cancer

This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat fear of cancer recurrence (FCR), psychiatric (anxiety, depression) distress and quality-of-life (QOL), in 100 outpatients with early-stage breast cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center randomized controlled trial (RCT) comparing a single 25mg oral 'high' dose of psilocybin to a single 5mg oral 'low dose psilocybin (active placebo), both delivered in conjunction with a psychotherapy platform.

Mindfulness Intervention on Minimally Invasive Vascular Surgery

The goal of this clinical trial is to learn whether a virtual reality (VR)-based mindfulness intervention can reduce anxiety and pain in adults undergoing minimally invasive surgery for lower-extremity varicose veins under local anesthesia. The study will also examine whether the intervention affects vital signs, fatigue, sleep quality, and patient satisfaction. The main questions this study aims to answer are: * Does VR-based mindfulness reduce patients' anxiety during surgery compared with routine psychological care? * Does VR-based mindfulness reduce perioperative pain and improve other patient-reported and physiological outcomes? Researchers will compare a VR-based mindfulness intervention with routine psychological care. A total of 160 participants will be randomly assigned to one of the two groups. Participants in the VR-based mindfulness group will: * Receive a VR-based mindfulness session in the preoperative waiting area. * Begin a VR-based mindfulness session at the start of surgery. The intraoperative intervention will be repeated till the end of surgery. Participants in the control group will receive routine psychological care before and during surgery. Participants in both groups will: * Complete assessments of state anxiety approximately 30 minutes before surgery, immediately before surgery, following the first completion of intraoperative VR-based mindfulness session, and after surgery. The third assessment will be conducted at the corresponding intraoperative time point in the control group. * Rate their pain before surgery and, at the end of surgery, report both their current pain intensity and the highest level of pain experienced during surgery. * Have blood pressure and heart rate measured before surgery and monitored at regular intervals throughout surgery. * Complete assessments of fatigue in the preoperative waiting area and again on the first postoperative day. * Complete assessments of sleep quality in the preoperative waiting area and again on the first postoperative day. * Complete a satisfaction assessment on the first postoperative day.

Lavender Inhalation for Anxiety in Patients Undergoing Coronary Angiography

This study evaluated the effects of lavender essential oil inhalation on anxiety, pulse rate, and blood pressure in patients undergoing coronary angiography. Participants were assigned to either the lavender inhalation group or the routine care control group in a 1:1 ratio by drawing lots. In the intervention group, three drops of lavender essential oil were applied to cotton placed in a small container approximately 30-40 cm from the patient. Inhalation continued during the waiting period before coronary angiography. The control group received routine care without aromatherapy. Anxiety was measured using the State Anxiety Inventory, and pulse rate and systolic and diastolic blood pressure were measured before the intervention and immediately after patients returned to the unit following coronary angiography.