Clinical Research Directory

Reiki After Bariatric Surgery

The aim of this clinical trial was to determine whether Reiki administered to patients after bariatric surgery reduced abdominal distension, nausea and vomiting, and pain severity, and improved their comfort levels. The primary research questions were as follows: Does Reiki reduce abdominal distension, nausea and vomiting, and pain severity? Does Reiki improve patient comfort? The researchers compared Reiki with sham Reiki (a procedure designed to resemble Reiki) and routine care. Seventy-five patients were assigned to one of the three groups using stratified randomization according to age and sex. Participants: For three days after bariatric surgery, participants received one session of Reiki, one session of sham Reiki, or routine care and completed questionnaires assessing abdominal distension, nausea and vomiting, pain, and comfort.

The Effect of Nursing Care Based on Kolcaba Comfort Theory in the Delivery Room

Newborns may experience pain, stress, and physiological changes during and after birth. Appropriate nursing care during this period can reduce negative effects by increasing the baby's comfort. Kolbaba's Comfort Theory aims to provide holistic care by supporting physical, psychological, environmental, and sociocultural comfort. This study aims to investigate the effects of nursing interventions based on Kolcaba's theory on pain, comfort, crying duration, and physiological parameters (heart rate, respiratory rate, SpO₂, body temperature, etc.) in noenates delivered vaginally. The findings aim to reveal the contribution of comfort-focused approaches in noenates care to clinical outcomes.

Reiki Before Colonoscopy

The goal of this clinical trial was to learn whether Reiki given before colonoscopy affects patients' anxiety and comfort. The main questions were: Does Reiki reduce anxiety? Does Reiki improve comfort? Researchers compared Reiki with sham Reiki (a procedure designed to resemble Reiki) and routine care. Seventy-six patients were randomly assigned to one of the three groups. Participants: Received one Reiki session, one sham Reiki session, or routine care before colonoscopy Completed questionnaires about anxiety and comfort

Using Wet Towel During Labor

The goal of this clinical trial is to learn whether the wet towel method applied during the first stage of labor can reduce labor pain and anxiety and improve childbirth comfort in first-time mothers. The main questions it aims to answer are: Does the wet towel method reduce labor pain? Does the wet towel method improve childbirth comfort? Does the wet towel method reduce anxiety during labor? Researchers will compare women who receive the wet towel method in addition to routine intrapartum care with women who receive routine intrapartum care alone to determine whether the intervention improves maternal outcomes during labor. Participants will: Be randomly assigned to either the wet towel intervention group or the routine care control group. Receive the wet towel application for at least 10 minutes during the active phase of the first stage of labor or receive routine intrapartum care only. Complete assessments of labor pain, childbirth comfort, and anxiety before and after the intervention using validated measurement tools

Feasibility of a Modified Dental Comfort Position for Pediatric Patients Receiving Dental Exams

The goal of this study is to learn if a modified bottom-to-bottom comfort position is a feasible alternative to the traditional knee-to-knee position during dental hygiene examinations for patients aged 12 months to 5 years. In the modified position, the patient sits in their caregiver's lap and reclines their head on the dental chair, allowing for both parental contact and dental provider access to the patient's mouth. This study will also examine the modified position's impact on the patient's distress and cooperation during the exam, parental satisfaction, and provider perception. The main questions are: Is the modified comfort position a safe and feasible alternative for young children undergoing dental hygiene exams? How does the modified comfort position impact patient completion rate and dental exam duration? How does the modified comfort position impact patient distress and cooperation, parental satisfaction, and provider acceptability? Participants will: Utilize the modified comfort position with the guidance of a Certified Child Life Specialist. Undergo a routine dental hygiene exam. Answer survey questions about parental satisfaction and patient psychological and developmental diagnoses. Dental providers will answer survey questions about acceptability and feasibility.

Effects of Hot Sacral Massage and Shower Application With Partner Support on Labor

This study was designed to determine the effect of warm sacral massage with cherry pits and showering with partner support on perceived labor pain, birth experience, and birth comfort. A total of 150 pregnant women, 50 in each group, were planned to be included in the study. Volunteers who agreed to participate in the study were expected to have spontaneous vaginal delivery, with an ultrasound-estimated fetal weight between 2500-4000 grams, a single fetus in cephalic presentation, at term (between 37-42 weeks of gestation), in the active phase of labor (4 cm cervical dilation), primiparous women who did not receive analgesia or anesthesia during the first stage of labor and who did not have any skin disease or open wound that would prevent massage or showering. Pregnant women participating in the study will be randomly divided into three groups. The massage group will receive massage twice during the first stage of labor for at least 20 minutes, either standing or sitting, using a bag filled with cherry pits on the sacral region (the lumbar region including your tailbone). Pregnant women in the shower group will receive a shower with water at a temperature between 32-37°C for at least 20 minutes twice during the first stage of labor, either standing or sitting with partner support, according to their preference. Pregnant women in the control group will not receive any intervention other than the routine hospital protocol (midwifery care). After providing information about the study to the pregnant women, written informed consent will be obtained. The pain scale (VAS) and The Birth Comfort Scale (BCS) will be administered to women in the shower group, massage group, and control group by a midwife working in the delivery room who is not involved in the study. The VAS will be administered four times during labor to pregnant women in the massage group and shower group, and four times to pregnant women in the control group.The Birth Comfort Scale (BCS)will be administered three times during labor to pregnant women in the massage group, the shower group, and the control group. Before transfer to the ward after delivery, all participants in the groups will be administered the "Birth Experience Scale (BES)" by a midwife who is not involved in the study and is working in the delivery room that day.

Maternal Voice Versus White Noise in Pediatric Surgery

This randomized controlled study will evaluate the effects of maternal voice and white noise on postoperative pain, comfort, and physiological parameters in children aged 1 month to 3 years during the early postoperative period. The study will also compare the effectiveness of maternal voice and white noise in improving these outcomes.

Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Extracorporeal Shock Wave Lithotripsy

Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL

Virtual Reality Intervention in Children After Hypospadias Surgery

The aim of this study is to examine the effect of virtual reality glasses use on pain, comfort, and psychosocial symptoms in children after hypospadias surgery.

The Effect of Kangaroo Care Education on Mother-Infant Bonding, Maternal and Neonatal Comfort

Kangaroo care encompasses early and continuous skin-to-skin contact, frequent and regular breastfeeding, early discharge from the hospital, and other supportive care practices necessary for the infant . Through kangaroo care, the transition of newborns from intrauterine to extrauterine life is facilitated, and a strong and secure bond between the mother and the newborn is established. Kangaroo care, which does not require any additional equipment or special preparation, is a safe method that can be easily and frequently implemented due to its numerous benefits. Since maternal and neonatal health affects not only the family but also public health, maternal and neonatal comfort is considered to be of great importance. Kangaroo care is believed to contribute positively to the enhancement of this comfort and the strengthening of the mother-infant bond. Despite the well-documented benefits of kangaroo care in the literature, its implementation in our country has not reached the desired level. This study is planned to determine the effect of kangaroo care education provided to pregnant women in the third trimester on mother-infant bonding and maternal and neonatal comfort.

Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults

Occlusal splints are commonly used to manage sleep bruxism, temporomandibular disorders, and tooth wear. Traditionally, a wax bite registration is used during the fabrication of CAD/CAM occlusal splints to determine the vertical dimension and occlusal relationship. New digital techniques allow the splint to be designed without a wax bite registration by virtually increasing the vertical dimension based on maximal intercuspation. This randomized crossover study compares these two fabrication workflows in healthy volunteers. Participants will wear both splints in random order. The study will evaluate patient-reported comfort and clinical performance, including occlusal contacts, force distribution, splint stability, and the occlusal adjustments required during insertion

Effect of Postoperative Oral Rinsing on Dehydration-Related Discomfort, Comfort, and Bowel Sounds

The aim of this study is to evaluate the effects of oral rinsing with water in the postoperative period on thirst, comfort level, and bowel motility in patients undergoing abdominal surgery under general anesthesia. This study was conducted as a randomized controlled trial with pretest-posttest design, including intervention and control groups. It was carried out between June 2024 and December 2024 with patients undergoing elective abdominal surgery. Sample size was calculated using G\*Power 3.1.9.7 software, with an effect size of 0.50, α=0.05, and power=0.85. A total of 82 participants (41 per group) were initially planned, and considering a 10% data loss, the study was completed with 98 participants (49 in each group). Patients were stratified according to their diagnoses and randomized in a 1:1 ratio using block randomization with a random number table. Three data collection forms were used. SPSS 22.00 package program was used to analyze the data. Skewnes-Kurtosis analyses were performed to determine the conformity of the data to a normal distribution. Frequency (n) and percentage (%) distributions were calculated to determine the sociodemographic and clinical characteristics of the participants. A t-test for independent samples was used to determine the mean differences between two independent groups, a t-test for dependent samples was used to compare pre- and post-intervention measurements, and a single-factor analysis of variance (ANOVA) was used for repeated measures. Cohen's d effect size was calculated to assess the significance of the difference between the groups in terms of the intervention. Statistical significance was accepted as p\<0.05.

VR Effects After Hip Replacement Surgery Pain

Total Hip Arthroplasty (THA), a procedure performed to enhance the quality of life, is accompanied by postoperative challenges such as pain and anxiety that adversely affect patient comfort. Inadequate management of these complications can prolong the length of hospital stay, delay recovery, lead to functional impairments, and elevate the risk of chronic pain development. Conventional pharmacological interventions employed for management are limited due to their potential for adverse effects and dependency. Virtual reality (VR) is a non-pharmacological distraction technique utilized in the healthcare sector, leveraging advanced technology to maximize patient comfort by alleviating pain and minimizing anxiety. A review of the literature reveals that while the use of VR has positive effects on pain and anxiety, there is a notable scarcity of high-quality randomized controlled trials concurrently evaluating its impact on pain, anxiety, and comfort levels in postoperative orthopedic procedures such as THA. In this randomized controlled trial, participants in the control group will receive standard care, whereas those in the experimental group will receive a 30-minute VR intervention-offering three distinct options-in addition to standard care during the acute phase of the first 48 hours. Postoperative assessments will be conducted using the Visual Analogue Scale (VAS) for pain intensity, the State Anxiety Inventory for anxiety levels, and the Perianesthesia Comfort Scale for comfort levels. By evaluating the potential of VR as a non-pharmacological adjuvant in post-THA care, the findings of this study will provide significant contributions to evidence-based nursing practices aimed at developing multimodal pain management strategies, reducing opioid consumption, and enhancing patient satisfaction.

The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing

Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of nonreactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important.

The Impact of Enhanced Music & Natural Visuals on Emotional Health

The investigators are conducting research on factors related to the self-regulation of mood and arousal states across a range of everyday activities as well as different levels of stress. Behavioral interventions-such as meditation, listening to music, or visualizing art or nature-offer important alternatives and/or adjunctive strategies to pharmaceutical tools or other mechanisms supporting physical and emotional well-being. This research will expand on the knowledge base regarding the impact of biophysical stimulation and/or frame of mind on an individual's self-directed management of physical and emotional health. Motivation, confidence, and composure are critical aspects of self-efficacy, framing a person's mindset to make healthy choices across daily activities. The research in this protocol is carried out across multiple sites and studies by means of digital tools and a consistent participant experience workflow. Together, these resources are intended to support individuals across multiple self-directed experiences utilized in the maintenance of their basic health. Before, during, and after session experiences, the participant provides objective (physiological) responses and/or subjective (self-report) responses and reflections; some studies also include interviews or focus groups. The combined set of responses can be summarized, connected to other measures, and input to machine learning models to improve personalization of stimuli. By studying the effects of soundBrilliance experiences across a variety of contexts and participant samples, the investigators can better refine each element of the stimulus to improve satisfaction, tolerance, and targeted outcomes.

The Effect of Video Streaming With Virtual Reality Before Coronary Angiography

This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography. Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form.

THE EFFECT OF REIKI APPLIED DURING THE POSTPARTUM PERIOD ON THE QUALITY OF POSTPARTUM RECOVERY, COMFORT AND MOOD.

The postpartum period, also defined as the fourth trimester of pregnancy, encompasses the approximately 6-8 week period following childbirth, during which the organs that underwent changes during pregnancy return to their previous state. This period is of great importance in terms of protecting the health of both mother and baby, meeting their care needs, and increasing their comfort. During the postpartum period, women experience physiological, psychological, and social changes; hormonal changes, assuming parental roles, changes in family dynamics, and increased responsibilities related to infant care can lead to adjustment difficulties. This can cause problems for the mother in both her own care and infant care. In the postpartum period, mothers may experience various health problems such as pain, fatigue, sleep disturbances, infections, breastfeeding problems, hemorrhoids, constipation, urinary incontinence, depressive symptoms, and mood swings. Pain, in particular, arises due to uterine contractions, breast engorgement, nipple tenderness, and other complications, negatively affecting the mother's mobility, sleep patterns, social interaction, and quality of life. Furthermore, stress and adjustment problems experienced during the postpartum period can lead to serious psychological problems such as delayed maternal bonding, postpartum blues, postpartum depression, psychosis, and communication problems between couples. Pharmacological and non-pharmacological methods are used in the management of these problems. However, due to the negative effects that pharmacological methods may have during breastfeeding, interest in complementary and alternative medicine practices has increased. Reflexology, aromatherapy, music therapy, acupressure, and Reiki are among these methods. Reiki is an energy therapy method that aims to balance an individual's life energy and support the natural healing process, applied through touch or the placement of hands on specific points. Reiki application is reported to have positive effects on pain, stress, anxiety, sleep quality, and coping skills. Although it is one of the preferred methods for adapting to changes and reducing problems experienced in the postpartum period, studies directly examining the effects of Reiki application on postpartum recovery quality, comfort, and mood are quite limited. Due to its low cost, ease of application, and lack of side effects, Reiki is considered an important complementary care approach that can be used in the postpartum period. The aim of this study is to determine the effect of face-to-face Reiki treatment on the quality of postpartum healing, comfort level, and mood in women who have had cesarean deliveries, on days 1, 2, and 7 of the postpartum period.

Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart

Introduction: The aging of the population is a global phenomenon, with projections indicating a significant increase in the proportion of individuals aged 60 years and older by 2050. This demographic shift requires adapting emergency department (ED) services to meet the specific demands of older patients, who often present with multiple comorbidities and face challenges such as sensory and cognitive difficulties. EDs, traditionally designed for acute illness and injury management, may not be adequately equipped to meet the unique needs of this vulnerable population. This can result in suboptimal patient experiences, prolonged ED stays, increased hospitalizations, and poorer outcomes. Methods: This study protocol outlines a before-and-after study to evaluate the impact of implementing a comfort menu and cart on the experience and outcomes of older patients treated in the ED. The study will be conducted in the ED of Hospital Sírio-Libanês (HSL), a tertiary private hospital in São Paulo, Brazil. Patients aged 60 and older who presented to the ED will be eligible for inclusion. Participants will be recruited in two phases: pre-intervention and post-implementation of the comfort menu and cart. Data will be collected through patient and staff interviews, chart reviews, and a 30-day follow-up interview. Patient experience, staff experience, length of hospital stays, hospital costs, ED readmissions, falls, delirium incidence, quality of life, functional status, cognitive performance, and mortality will be assessed. Ethics and dissemination: Ethical approval for this study has been granted by the Institutional Review Board of HSL. All participants, or their legal representatives for those with cognitive impairment, will provide written informed consent before any study procedures are initiated. The consent process has been designed keeping the study hypothesis blind by not revealing the outcomes that will be measured after the comfort cart intervention. The results will be shared with the academic community through peer-reviewed publications and presentations at relevant conferences to inform future clinical practice and research. Expected Results: A positive impact of implementing the comfort menu and cart in the ED is expected on patient-centered outcomes. Improvements in the experience of older patients and medical and multidisciplinary staff are anticipated, and improvements in other exploratory outcomes, such as length of hospital stay, hospital costs, readmissions, falls, delirium incidence, quality of life, functionality, and cognitive performance, will be explored.

Effect of Yoga and Values Clarification on Stress, Comfort, and Emotional Regulation in Parents of Children With Special Needs

Parents of children with special needs often experience high levels of stress and difficulties in emotional regulation, which may negatively affect both their well-being and parent-child interactions. This study aims to evaluate the effect of a Comfort Theory-based yoga and values clarification intervention on emotional regulation, comfort, and perceived stress levels in these parents. This randomized controlled study will include three groups: a yoga intervention group, a values clarification group, and a control group. Participants will be randomly assigned to groups. Data will be collected using the Emotion Regulation Scale, Perceived Stress Scale, and General Comfort Questionnaire. The intervention is expected to improve emotional regulation and comfort levels while reducing perceived stress among parents of children with special needs. The findings may contribute to the development of effective nursing interventions to support caregiver well-being.

Mandala Painting During Chemotherapy

In addition to managing drug side effects that arise during cancer treatment, maintaining the patient's psychosocial well-being is also very important. Therefore, the aim of this project is to examine the effect of mandala painting during chemotherapy on anxiety, nausea, and comfort levels. This project aims to reduce the negative effects of chemotherapy, such as nausea, anxiety, and decreased comfort, by distracting the patient's attention through the non-invasive and non-pharmacological practice of mandala coloring in patients undergoing chemotherapy. Mandala painting is a distraction and positive focus practice. A limited number of studies conducted on cancer patients have shown that it reduces distress and improves psychological well-being. However, no study in the literature has comprehensively addressed the symptoms experienced by patients during chemotherapy, such as anxiety, nausea, intense stress, and impaired comfort. The research will be conducted on patients undergoing chemotherapy for the first time, and patients in the experimental group will engage in mandala coloring for at least 30 minutes. Data obtained from assessments conducted before and after chemotherapy will be compared with control group data. This project will provide a more comprehensive assessment of the effect of mandala painting, a non-pharmacological intervention, on the negative symptoms of patients undergoing chemotherapy for the first time. In addition to its scientific contribution, it is believed that effective symptom management can contribute to patients' well-being. Furthermore, if nausea can be controlled, the need for antiemetics during treatment can be reduced. This will also contribute to reducing unwanted drug effects and lowering costs.

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 Kegel Pelvic Floor Muscle Exercises on Urinary Retention, Pain, and Comfort Levels in Patients After Lumbar Disc Herniation Surgery: A Randomized Controlled Clinical Trial

This study was planned as a randomized controlled trial to investigate the effects of Kegel pelvic floor muscle exercises on urinary retention and comfort levels of patients after lumbar disc herniation surgery.

Virtual Reality (VR) Based Relaxation for Nausea and Comfort in Pregnancy

This study aims to evaluate the effect of a virtual reality (VR)-based visual relaxation intervention on nausea and vomiting severity, sleep quality, and comfort in pregnant women. Nausea and vomiting are common symptoms during pregnancy and may negatively affect women's quality of life and overall well-being. Non-pharmacological interventions such as VR-based relaxation may provide a safe and effective alternative to improve these symptoms. In this randomized controlled study, pregnant women will be assigned to either an intervention group receiving VR-based relaxation or a control group receiving standard care. The outcomes will be assessed using validated measurement tools for nausea and vomiting severity, sleep quality, and comfort. The findings of this study are expected to contribute to improving maternal comfort and supporting non-invasive care approaches during pregnancy.

Comfort Care Bundle

Intensive care units (ICUs) are specialized units where numerous complex treatment and care procedures are applied. In these units, critically ill patients are exposed to stressful conditions and experience significant pain and other discomforts stemming from multiple internal and external factors that can alter their quality of life and trigger symptoms of post-traumatic stress disorder (PTSD). These discomforts can have various short-term or long-term consequences for patients after discharge from the ICU, such as anxiety and/or depression or PTSD, which can affect their quality of life. Therefore, knowing the negative factors affecting patient comfort in the ICU, as well as measuring patient comfort and eliminating or reducing these factors through comfort care, is crucial in reducing morbidity and mortality rates in patients. It is noteworthy that there is no specific care package in the literature aimed at improving ICU-specific comfort. Accordingly, this study aims to develop a "Comfort Care Package" to improve the comfort level of ICU patients. The research population will consist of all patients aged 18-65 years admitted to the intensive care units of Bursa City Hospital. This study will test the effect of the developed "Comfort Care Package" on the comfort level and physiological parameters of 88 ICU patients (control group=44 and study group=44) who meet the inclusion criteria and whose data were calculated using the G\*Power 3.1 program. The study will begin with the collection of data from the control group. This group will receive routine ICU care. The study group will receive the Comfort Care Package. It is anticipated that the ICU-specific comfort care package developed within the scope of this study will make significant contributions to the creation of nursing care plans aimed at increasing the comfort levels of critically ill individuals. Therefore, in patients with improved comfort, targeted recovery outcomes may increase, mortality rates may decrease, and thus public health may be sustained.