Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Patients go to operating room walking with their families and with their normal clothes

Patients go to operating room by stretcher on wheels and with hospital clothes. Normal routine of our hospital.

Transport on foot

Gabriela da S Oliveira, Nurse

Cancer is an extremely aggressive disease, anxiety and depression are consequences some patients may develop from diagnosis continuing during treatment. A measures control of the cancer is surgery for removal tumor. The surgical procedure is often a difficult experience for patients and their relatives, and patients in the preoperative period are often psychological symptoms of anxiety and depression. A previous study with the objective analyzing patient's emotional repercussion according the type of transport to the surgical center reached the following result: patients who go to the surgical center feel more relaxed in the preoperative period.

The primary objective is to analyze emotional repercussion of patient diagnosed with cancer classified in Eastern Cooperative Oncology Group (ECOG) Performance Status 0 and 1 according type transport to the surgical center.

A randomized clinical trial, prospective collection to be performed at the Barretos Cancer Hospital, will be include 176 patients, 88 patients being allocated to transport to operating room by stretcher on wheels (group 1) and 88 patients being allocated to transport to operating room by ambulation (group 2). Patients with indication elective surgery that meet the inclusion criteria will be included, and randomized for one of the groups, and may be referred by stretcher on wheels to the surgical center (group 1) or referred to the surgical center by ambulation (group 2). The Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery, will be the instruments used in data collection. Participants will respond both after the course to the surgical center.

Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center

Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center: a Randomized Clinical Trial Comparing Transport by Stretcher on Wheels and Ambulation.

We do not intend to share our individual participant data to other researches

Measure the anxiety and depression levels using Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery

Barretos Cancer Hospital

Symptoms and General Pathology

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Neoplasms

Musculoskeletal Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Sclerosis

Syndrome

Hyperkinesis

Autism Spectrum Disorder

Neurodevelopmental Disorders

Autistic Disorder

Phobia, Social

Impulsive Behavior

Fragile X Syndrome

Tourette Syndrome

Tics

Tic Disorders

Tuberous Sclerosis

Agoraphobia

DiGeorge Syndrome

22q11 Deletion Syndrome

Anxiety, Separation

Phobic Disorders

Child Development Disorders, Pervasive

Developmental Disabilities

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Movement Disorders

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Intellectual Disability

Mental Retardation, X-Linked

Neurobehavioral Manifestations

Neurologic Manifestations

Chromosome Disorders

Sex Chromosome Disorders

Congenital Abnormalities

Genetic Diseases, X-Linked

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Dyskinesias

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Heart Defects, Congenital

Cardiovascular Abnormalities

Heart Diseases

Lymphatic Abnormalities

Lymphatic Diseases

Abnormalities, Multiple

Hypoparathyroidism

Parathyroid Diseases

Endocrine System Diseases

Tuberous Sclerosis Complex

22q11.2 Deletion Syndrome

Lymphatic Malformations

Psychotropic Drugs

All Drugs and Chemicals

Sertraline

Selective Serotonin Reuptake Inhibitors

Serotonin

Antidepressive Agents

Neurotransmitter Agents

Serotonin Receptor Agonists

Placebo

Karly Janisse

Paul Arnold

Francois Bolduc

Megan Thomas

Alessia Greco

Elisabetta Trinari

Ramona Rego

Sarosh Khalid-Khan

Baudouin Forgeot D'Arc

Evdokia Anagnostou

There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

The MASC-2 will be used as an additional anxiety measure to examine the effect of sertraline vs. placebo on measures of anxiety. The MASC-2 can be rated by parents or completed as a self-report. The parent rated version will be used and if the participant has adequate language ability, the self-report will also be used. The MASC-2 is a 50-item questionnaire. Each item is rated from 0 (Never) to 3 (Often). A higher score is indicative of higher symptoms of anxiety.

The CGI-S is a clinician reported scale which will be used to examine the effect of sertraline vs. placebo on measures of global function. The CGI-Severity Scale employs a seven point (1 = Normal, not at all ill to 7 = among the most extremely ill patients) to determine the participant's initial level of severity of impairment.

The SCARED is a 41-item measure of anxiety symptoms, with both child and parent versions. The Child version will be used as an exploratory outcome measure. The minimum overall score is 0 while the maximum overall score is 82. A score greater than or equal to 25 may indicate the presence of an Anxiety Disorder. Higher scores indicate a higher instance of anxiety symptoms while a lower score indicates a lower instance of anxiety symptoms.

The CGI-I is a clinician reported scale which will be used to examine the effect of sertraline vs. placebo on measures of global anxiety. The CGI-Improvement Scale employs a seven point (1 = very much improved to 7 = very much worse) to determine the participant's improvement in response to treatment.

The Parent Chief Complaint will be used to examine the effect of sertraline vs. placebo on individualized target symptoms. The objective of this measure is to have the parent describe the frequency and severity of one or two primary concerns of their child's behavior at the baseline visit and again at the end of treatment. Frequency is rated as Very Often (3), Often (2), Sometimes (1), or Rarely (0), and Severity is rated as Mild (1; behaviour occurs and is a mild problem), Moderate (2; behaviour occurs and is a moderate problem), and Severe (3; behaviour occurs and is a severe problem).

The PRAS-ASD will be used to examine the effect of sertraline vs. placebo on measures of anxiety in ASD. It is completed by the parents and includes 25 questions rated on a scale for 0-3 (none-severe problem).

The ADAMS is designed to assess anxiety and depression in children with and without intellectual disability. The ADAMS is a 28 item questionnaire which is rated by the parent. Each item is rated from 0 (behaviour has not occurred, or is not a problem) to 3 (behaviour occurs a lot, or is a severe problem).

The SCARED is a 41-item measure of anxiety symptoms, with both child and parent versions. The parent version will be used as a primary outcome measure. The minimum overall score is 0 while the maximum overall score is 82. A score greater than or equal to 25 may indicate the presence of an Anxiety Disorder. Higher scores indicate a higher instance of anxiety symptoms while a lower score indicates a lower instance of anxiety symptoms.

The CGI-I is a clinician reported scale which will be used to examine the effect of sertraline vs. placebo on measures of global function. The CGI-Improvement Scale employs a seven point (1 = very much improved to 7 = very much worse) to determine the participant's improvement in response to treatment.

The SMURF will be administered by the clinician at each visit to examine the safety and tolerability of sertraline. This rating covers a range of behavioural and physical AEs that are relevant to SSRIs.

The PedsQL will be used to examine the effect of sertraline vs. placebo on measures of quality of life. The PedsQL is measuring health-related quality of life (HRQOL) in 2- to 18-year-olds. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent-proxy report scales that have been used extensively as an outcome measure, including in ASD. We will use the parent-proxy report scale, and optionally, age-appropriate child self-report scale. Each item is is rated between a 0 (Never a problem) to 4 (Almost always a problem).

The HUI-3 will be used to examine the effect of sertraline vs. placebo on measures of general health status and health-related quality of life. The study is using the parent-proxy version of the HUI-3. The HUI-3 is a 15-item questionnaire to classify a subject's health status.

A whole blood serotonin assessment will be completed to examine the effect of sertraline vs. placebo on biomarkers of serotonin. 3mL of blood will be drawn at screening and week 16 visits for the purpose of this assessment. High performance liquid chromatography will be performed using fluorometric detection of 5-HT, tryptophan (TRP), and 5-hydroxyindole acetic acid (5-HIAA), using N-methylserotonin as an internal standard. Using this method, 5-HT intra- and inter- assay coefficients of variation are reliably less than 5% and 10%, respectively.

Azrieli Foundation

Canadian Institutes of Health Research (CIHR)

Ontario Brain Institute

Holland Bloorview Kids Rehabilitation Hospital

McMaster University

Western University

Queen's University

University of Alberta

Alberta Health services

St. Justine's Hospital

Dalhousie University

Unity Health Toronto

University of Toronto

The Hospital for Sick Children

Anagnostou, Evdokia, M.D.

Stress, Psychological

Mindfulness-based breathing and music therapy

60 patients in the mindfulness-based breathing and music therapy group were divided into subgroups of 5 participants each. Each 6-person group started by having participants complete the pretest State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale via Survey Monkey. Mindfulness-based breathing and music therapy was applied to each patient group in approximately 45-minute sessions per day. At the end of the session, participants re-filled the posttest State Anxiety Inventory, Work-Related Tension Scale, and Psychological Well-Being Scale. A total of 3 sessions were completed with an interval of two days.

Mindfulness

Dilek YILDIRIM, Ph.D

Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.

Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.

Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or practice (intervention?) on anxiety, tension, depression symptoms and coping with stress were included in the study. Participitants randomised intervention and controlled groups.

Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.

Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.

Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or intervention on anxiety, tension, depression symptoms and coping with stress were included in the study.

Sample size and randomization The sample number was calculated using the GPower 3.1.9 version program. At an effect size of 0.5 and an error level of 0.05 \[alpha\], the required sample size was determined to be at least 54 individuals for each group. A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature (Lee et al., 2020). The power of the analysis made with this sample size was determined as 93.1%. Considering the losses during the study, the sample number for each group was determined as 60 people.

The groups of participants who agreed to participate in the study were determined by the program with the randomization URL http://www.randomization.com/. In order to distribute the numbers to the groups, the numbers from 1 to 120 were randomly assigned to the two groups, assuming that set 1 would represent the intervention group and set 2 would represent the control group. In line with the program, the order of the patients forming the sample group was determined by randomization. A total of 130 patients, 65 in the intervention group and 65 in the control group, were included in the study. 5 participants in the intervention group who did not want to participate and died during the study, and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation. In the study, the results of a total of 120 patients, 60 in the intervention group and 60 in the control group, were analyzed.

Measures/Instruments Participant Information Form, State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale were used to collect research data. Survey Monkey was used as the data collection method. The Survey Monkey survey was created, which provides self-access and makes it easier to collect and track data by preventing multiple data entries from the same person. Confidentiality was ensured by completely disabling electronic and IP address registrations to receive anonymous responses.

The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients

The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients: Single Blinded Randomized Controlled Study

This form was developed by the researchers to include the age, gender, marital status, educational status, and treatment method of the participants.

The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).

The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.

Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.

Istanbul Aydın University

Assistant professor Dr.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center	NCT03576482	Anxiety Disorde... Depression	Transport on fo...	18 Years - 70 Years	Barretos Cancer Hospital
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders	NCT06081348	Neurodevelopmen... Autism Autism Spectrum... Fragile X Syndr... Tuberous Sclero... 22Q11 Deletion ... 22Q11 Deletion ADHD Tic Disorders Tourette Syndro... Tourette Syndro... Tourette Syndro... ADHD - Combined... ADHD Predominan... ADHD, Predomina... Provisional Tic... Anxiety Anxiety Disorde... Agoraphobia Generalized Anx... Generalized Anx... Social Anxiety Social Anxiety ... Unspecified Anx... Other Specified... Separation Anxi...	Sertraline Placebo	8 Years - 17 Years	Anagnostou, Evdokia, M.D.
The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients	NCT05187130	Neoplasms Cancer	Mindfulness	18 Years -	Istanbul Aydın University

Spots Global Cancer Trial Database for anxiety disorders