Clinical Research Directory

Effects of Cartoons and Mobile Games on Preoperative Anxiety and Fear in Children With Appendicitis: An RCT

his study aims to evaluate the effects of cartoon viewing and mobile game playing on preoperative anxiety and fear levels in children aged 7-12 years who are hospitalized for appendicitis surgery. The study is designed as a randomized controlled trial with three groups: a cartoon group, a mobile game group, and a control group receiving routine care. Children in the intervention groups will watch a cartoon or play a mobile game for 10 minutes before surgery. Anxiety and fear levels will be measured using validated scales before and after the intervention. The findings of this study are expected to contribute to atraumatic care practices by providing simple and effective non-pharmacological methods to reduce preoperative anxiety and fear in children.

Music and VR Effects on Pain, Anxiety, and Fear During Oral Mucositis Care in Leukaemic Children

Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. The pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. Since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. In this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. Block randomisation (gender (F/M) and age groups (6-9/10-12) will be used to identify participants. Five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the Child Anxiety Scale-Disposition (CAS-D), Child Fear Scale and Visual Analogue Scale (VAS). The study will be conducted in three groups as control group, VR group and music group. Descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. In examining the relationship between dependent and independent variables, Mann Whitney-Kruskal Wallis or Student t-Anova analyses will be performed according to the result of the analysis of conformity to normal distribution. Bonferroni analysis will be used for pairwise comparisons and Covariance analysis will be used to investigate the effect of variables with children.

Comfort Intervention in PICU Children

This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.

The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Burn dressing is often a distressing and painful procedure for pediatric patients, which may lead to increased anxiety, physiological instability, and negative treatment experiences. In this study, child-friendly cartoon-printed adhesive bands are used as a non-pharmacological intervention to provide distraction and emotional comfort during burn dressing. By incorporating familiar and visually engaging designs, the intervention seeks to reduce children's perception of pain, alleviate stress, and improve physiological stability (heart rate, oxygen saturation, and respiratory rate) during the procedure. Participants will include children aged 7-11 years receiving burn care in a pediatric burn unit. They will be randomly assigned to either the intervention group (cartoon-printed band use) or the control group (standard plain band use). Fear, pain, and stress will be assessed using validated scales before, during, and after the dressing procedure. Physiological parameters will be measured using a pulse oximeter. The study is expected to contribute to the development of child-centered, non-pharmacological methods that make medical procedures less stressful and more tolerable for pediatric patients. Results may guide the design of more comforting and engaging treatment environments in pediatric burn care.

Child's Interaction With a Social Robot During Dressing

The aim of this randomized controlled trial, consisting of 30 experimental and 30 control groups, was to examine the effect of a child's interaction with a social robot during wound dressing on their fear and pain.

HBM-Based Solution-Focused Birth Program on Fear of Childbirth in Primigravidas

Pregnancy is a period characterized by significant physiological and psychosocial changes, during which women adapt to new roles. While some women experience this period with excitement and hope, others may experience anxiety, uncertainty, and fear. Fear of childbirth (tokophobia) is a common condition that can negatively affect women's quality of life, birth preferences, and childbirth experiences. High levels of fear of childbirth have been associated with increased cesarean section rates, negative birth perceptions, and postpartum psychological problems. This randomized controlled trial aims to evaluate the effect of a solution-focused childbirth preparation education program based on the Health Belief Model on fear of childbirth and belief in normal birth among primigravida women. Secondary outcomes include pregnancy-related stress and mode of delivery. Participants will be randomly assigned to either an intervention group receiving structured education or a control group receiving routine prenatal care. Data will be collected before and after the intervention using validated measurement tools, and delivery outcomes will be recorded after birth. The findings are expected to contribute to improving maternal psychological well-being and promoting positive childbirth experiences.

Effect of MBSR Training on Childbirth Fear, Bonding and Breastfeeding in Adolescent Pregnant Women

This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.

Empathy and Virtual Reality (VR)

This study will characterize the subjective and physiological changes associated with empathy following a fear-inducing virtual reality (VR) experience.

The Effect of Progressive Relaxation Exercises With Therapeutic Clown

This study was conducted to investigate the effects of progressive relaxation exercises, performed with the assistance of a therapeutic clown during the pre-operative period, on fear, anxiety and physiological parameters in children. This randomised controlled trial included children aged 6-10 years undergoing circumcision surgery. The children were randomised into three groups: a progressive relaxation exercise group led by a therapeutic clown, a progressive relaxation group led by a nurse, and a control group. Fear, anxiety and physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation) were assessed before and after the procedure.

The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery on Anxiety, Surgical Fear, and Hemodynamic Parameters

This study was designed as a randomized controlled trial to determine the effect of a stress ball applied before retrograde intrarenal surgery on patients' anxiety levels, surgical fear, and hemodynamic parameters.

AI Avatar Video vs. Tell-Show-Do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia

This randomized clinical trial aims to compare two behavior guidance techniques used to reduce anxiety in children during local anesthesia injections in dental treatment. The study evaluates the traditional Tell-Show-Do (TSD) technique versus an artificial intelligence (AI)-driven, avatar-based video method called the "Mini Dentist." Children aged 5 to 7 years who require local anesthesia for routine dental treatment will be randomly assigned to one of two groups. The control group will receive the conventional Tell-Show-Do explanation from the pediatric dentist. The experimental group will watch a short animated video featuring an AI-generated avatar that explains and demonstrates the procedure in a child-friendly manner before the injection. Anxiety and behavior will be assessed using heart rate monitoring, behavioral observation (FLACC scale), and a self-reported pain scale (Wong-Baker FACES). The goal is to determine whether the AI-based method improves cooperation and reduces anxiety compared to the traditional approach. Participation is voluntary, and all procedures follow ethical research standards.

Social Support and Enhanced Fear Extinction

University of California, Los Angeles researchers will recruit healthy participants and anxious participants (those diagnosed with social anxiety disorder) age 18-55 years old to participate in a study examining whether the ability of social support figure reminders to enhance the extinction of fear in healthy participants extends to those with anxiety disorders. After being recruited from the UCLA community (healthy participants, n = 50) or referred by treatment providers at the Anxiety and Depression Research Center at UCLA (anxious participants, n = 50) and undergoing a telephone screening and in-person screening, 100 participants will be enrolled in the study, with an expected recruited 150 to reach this number. During the experiment, all participants will undergo the same procedures: undergoing a fear extinction procedure in which threatening cues--cues that predict electric shock--will be paired with either an image of a social support figure (provided by participants) or an image of a smiling stranger. These pairings will be presented repeatedly in the absence of shock in order for fear extinction to occur. Participants will return for a follow-up test to determine if fear extinction was successful.

Social Support and Reduced Fear Acquisition

University of California, Los Angeles researchers will recruit healthy participants and anxious participants (those diagnosed with social anxiety disorder) age 18-55 years old to participate in a study examining whether the ability of social support figure reminders to prevent the acquisition of fear in healthy participants extends to those with anxiety disorders. After being recruited from the UCLA community (healthy participants, n = 50) or referred by treatment providers at the Anxiety and Depression Research Center at UCLA (anxious participants, n =50) and undergoing a telephone screening and in-person screening, 100 participants will be enrolled in the study. During the experiment, all participants will undergo the same procedures: undergoing fear acquisition procedures--the repeated pairing of a neutral image with a mild electric shock that ultimately leads to the association of threat of shock with the image--in the presence of an image of a social support figure (provided by participants) and an image of a smiling stranger.

Effect of Helfer Skin Tap and Vibration on Pain and Fear in Children During Intramuscular Injection

Intramuscular injection is one of the most common invasive procedures in childhood and is frequently associated with pain and fear. These negative experiences may affect children's attitudes toward healthcare and complicate nursing care. Therefore, using non-pharmacological methods is essential for promoting child-friendly services. This study aims to evaluate the effects of the Helfer Skin Tap and vibration techniques on pain and fear levels in children aged 5-10 years during intramuscular injections. The study is designed as a parallel, three-arm randomized controlled trial conducted in the Pediatric Emergency Clinic of Ege University Hospital. Participants will be allocated by simple randomization to Helfer Skin Tap, vibration, or standard care. Sample size was calculated with G\*Power 3.1 using a repeated-measures within-between interaction model with two time points (T0-T1), α=0.05, and power=0.80. Assuming a medium effect size (f=0.25) based on previous studies, at least 159 children are required. Allowing for 15% attrition, the final sample will include 186 participants (62 per group). Data will be collected using a Child Information Form including sociodemographic characteristics and prior injection experiences. A Procedure Record Form will document randomization, assigned group, medication, dose, injection site, duration, child's position, and parental presence. Pain and fear will be assessed immediately before (T0) and after (T1) the injection. Pain will be measured with the Wong-Baker FACES Pain Rating Scale (0-10) and fear with the Children's Fear Scale (0-4). Ratings will be obtained independently from the child, parent, and observing nurse. The procedure will be video-recorded to enable objective evaluation of behavioral responses. Recordings will be scored by an independent blinded expert using standardized criteria. Videos will be used only for research purposes, with identifying features concealed, stored in coded format, and destroyed after study completion.

Stress Ball Use During Cataract Surgery: Effects on Pain, Fear and Satisfaction

The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.

Effects of Cold Spray and Buzzy Device an Pain and Fear During Penicillin Injection

This study investigates the effect of cold spray and Buzzy devices on pain and fear experienced during penicillin injections. There are three groups: a cold spray and Buzzy device, and a control group. Penicillin injections are commonly used in clinical practice and can cause discomfort, pain, and fear, particularly in patients receiving intramuscular injections. Cold spray and Buzzy devices are non-pharmacological methods that can help reduce pain and fear by providing a cooling effect and vibration at the injection site. Participants will be randomly assigned to one of the study groups, and their pain and fear levels during injection will be assessed using standardized measurement tools. The results of this study are expected to contribute to improving patient comfort and supporting the use of simple, non-invasive methods to reduce pain and fear during injections.

The Effect of a Drama-Based Coloring Storybook on Children's Fear, Anxiety, and Pain Management in the Perioperative Process: "Alican's Brave Journey"

This randomized controlled study aims to evaluate the effect of a drama-based coloring storybook on children's fear, anxiety, and pain management during the perioperative process. The study will be conducted with children aged 6-9 years who are scheduled for elective surgery. Participants will be randomly assigned to either an intervention group receiving the drama-based coloring storybook or a control group receiving routine preoperative care. Levels of fear, anxiety, and pain will be assessed using validated measurement tools at predefined perioperative time points. The findings are expected to contribute to evidence-based, child-centered perioperative care practices.

Nonpharmacological Management of Pain and Fear During Hormone Injection in Breast Cancer Patients

This randomized controlled study will compare the effects of the ShotBlocker device and the Helfer Skin Tap Technique on pain and fear during intramuscular hormone injections in premenopausal and postmenopausal breast cancer patients. Ninety-nine participants will be randomly assigned to three groups (ShotBlocker, Helfer, control). All injections will be administered by the same nurse using standardized procedures. Pain will be assessed with the Visual Analog Scale, and fear with the Injection Fear Scale. The study aims to identify effective nonpharmacological methods to enhance patient comfort, support treatment adherence, and improve nursing care quality.

Walkway Used in Postoperative Mobilization

Introduction Surgical operations are increasing globally, with abdominal surgeries accounting for approximately 70% of these procedures. Despite the prevalence, postoperative complications occur in 30-60% of cases, leading to prolonged hospital stays, increased mortality, and higher healthcare costs. Early mobilization is a critical component of Enhanced Recovery After Surgery (ERAS) protocols, known to reduce surgical stress, muscle atrophy, and pulmonary complications. However, implementation in pediatric care is often limited, as children may perceive mobilization as a "task" rather than a part of healing. Purpose The primary aim of this study is to investigate the effects of a low-cost, distraction-based Walkway (Mat Carpet) on pain levels, fear, and the time to initiate mobilization in children aged 4-10 who have undergone abdominal surgery.

The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

Mindfulness-Based Emotion Regulation Training for Hospitalized Children

Hospitalization and medical procedures are a significant source of stress and anxiety for school-age children aged 7-11, who, due to their cognitive development, can perceive events but lack the capacity to cope effectively. The main objective of this project is to examine the effect of Mindfulness-Based Emotion Regulation Training, which will be applied to children aged 7-11 hospitalized in the pediatric clinic, on developing children's emotion regulation skills and reducing their fear levels related to the hospital. The research is a randomized controlled trial to be conducted between April 2026 and April 2027. Data will be collected using the "Child and Parent Introduction Form," the "Emotion Regulation Scale for Children and Adolescents," and the "Medical Procedure Fear Scale." While distraction techniques frequently used in the literature offer a quick and effective solution at the time of the procedure, this project differs in that it aims to provide children with sustainable emotion regulation skills that they can use not only at that moment but also in later stages of the illness and in future life events. As a result of the project, it is expected that the implemented training will increase adaptive emotion regulation strategies in children, significantly reduce medical fear and anxiety, and provide an evidence-based nursing intervention that will facilitate children's compliance with treatment.

The Effect of Therapeutic Play Applied Before Intramuscular Injection

This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures. Children, especially at an early age, show great sensitivity towards medical procedures, and these processes can often cause pain, anxiety and fear. This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures. Children, especially at an early age, show great sensitivity to medical procedures, and these processes can often cause pain, anxiety, and fear. This research aims to discover methods of managing and improving children's responses to medical procedures through therapeutic games. This study, to be conducted at the Emergency Department of Atatürk University Research Hospital in Erzurum, will be carried out using a randomised controlled design. Participants will be randomly assigned to intervention and control groups. Children in the intervention group will prepare using the therapeutic toy doll, while children in the control group will receive an intramuscular injection at the clinic using routine application methods. Data collection tools will include the Socio-demographic Information Form, the Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-D), and the Wong-Baker Facial Expression Rating Scale.

Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study

The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely.

The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety

This research will be conducted as a pre-test-post-test parallel group randomized controlled experimental study to determine the effects of two different types of hourglasses (liquid gel-based hourglass and sand-based hourglass) used for distraction during blood collection in children aged 5-10 years on pain, fear, and anxiety and the comparative effectiveness of these methods. Research Hypotheses H1: The mean pain, fear, and anxiety scores of children who used a liquid gel-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H2: The mean pain, fear, and anxiety scores of children who used a sand-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H3: The use of a liquid gel-based hourglass and a sand-based hourglass during blood collection had different effects on the mean pain, fear, and anxiety scores of children.