Active clinical trials for "Pain, Procedural"

A. Specific Aims Premature infants admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) known to cause pain [1]. Through funding from NINR, the investigators found that TDPs not only caused pain but also increased markers of ATP degradation and oxidative stress[2[. The TDP was tape removal, a commonly performed procedure in the NICU2. Based on this finding, the investigators sought to determine if interventions that relieve pain also reduce biochemical markers of ATP degradation and oxidative stress. The investigators first examined the effect of oral sucrose, a commonly used intervention, when given before a heel lance. The investigators chose heel lance because it is the most predominant painful procedure in the NICU, as shown in 29 different clinical trials[3]. The investigators hypothesized that since oral sucrose is documented to significantly reduce pain scores, then administration of this analgesic will also decrease markers of ATP degradation and oxidative stress. However,the investigators observed the opposite effect. Although a single dose of oral sucrose reduced behavioral markers of pain, it significantly increased biochemical markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) over time[4]. More importantly, the effect of oral sucrose on breakdown markers of ATP were enhanced and were significantly higher in neonates that were intubated or were receiving more than 30% FiO25. These findings lead to the question: If oral sucrose does not effectively reduce the biochemical effects of procedural pain, what intervention or groups of intervention will decrease both behavioral markers of procedural pain and reduce ATP utilization and oxidative stress in premature neonates? For this RO1 renewal, the investigators propose to test the individual and additive effects of two commonly used interventions for procedural pain. These interventions are (a) administration of 30% oral glucose and non-nutritive sucking (NNS) (b) facilitated tucking and NNS c) administration of 30% oral glucose, facilitated tucking and NNS. Administration of 30% oral glucose was documented to decreased procedural pain scores[6-9] without the potential adverse effects of fructose, a key ingredient of sucrose[10-11]. Facilitated tucking is the gentle positioning of preterm infants with arms and legs in a flexed, midline position close to the body, while either in a side-lying or prone position[12]. Because tachycardia often accompanies pain, a documented benefit of facilitated tucking is stabilization of heart rate and reduction of motor activity (flailing)[12-13]. Non-nutritive sucking refers to the provision of a weight-appropriate pacifier[14]. The painful procedure will be a clinically required heel lance, which refers to the puncture of a newborn's heel for blood glucose using a specially designed lancet. Our general hypothesis is that commonly used clinical interventions known to reduce procedural pain alter biochemical markers of ATP degradation, oxidative stress and cell injury. Specific Aim 1 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease procedural pain. • Pain will be quantified using a validated pain scoring tool, the Premature Infant Pain Profile (PIPP). Individual and additive effect of interventions will be determined. Specific Aim 2 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease biochemical markers of ATP degradation, oxidative stress and oxidative cell injury. Products of ATP breakdown in plasma-hypoxanthine (Hx), xanthine (Xa), and uric acid (UA)-will be measured using high performance liquid chromatography. Oxidative stress will be quantified by measuring plasma levels of allantoin using mass spectrometry. Cell injury will be quantified by measuring plasma levels of F2 isoprostane using liquid-chromatography/mass spectrometry.

This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Ethics committee approval, permissions from institutions and informed voluntary consent of the children were obtained in order to conduct the study. The data of the study were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. A p value of <0.05 was considered statistically significant in data analysis.

This study explored the feasibility, acceptability and perceived the effectiveness of an Immersive Virtual Reality (IVR) 'game' in the rehabilitation of children with upper limb injuries. The objectives of the clinical trial were: To qualitatively assess the perceptions of child and parent regarding the acceptability of the game and equipment, and their perceptions of its effectiveness in reducing pain and discomfort and facilitating movement, compared to usual physical therapy experiences. To qualitatively assess physical therapy practitioners' perceptions of the effectiveness, usability, feasibility, and acceptability of VR in their clinical setting with this client group. Hypothesis: IVR rehabilitation game as an intervention will be acceptable to child patients and their parents. IVR rehabilitation game experience will show less procedural pain, discomfort, and difficulties to movement, compared to usual physical therapy experiences. IVR rehabilitation game will demonstrate any perceived disadvantages as a therapeutic intervention, compared with usual rehabilitation care. IVR rehabilitation game will demonstrate usability in the clinical setting during the rehabilitation of a small sample of children with varying ULIs.

Infants admitted to Neonatal Intensive Care Unit (NICU) may experience a negative impact due to multiple painful and stressful procedures during their hospitalization. The American Academy of Pediatrics recommends that healthcare facilities taking care of newborns should implement pain prevention and management programs. There are some non-pharmacological techniques that have been developed to reduce newborn's pain perception, including swaddling, holding, non-nutritive sucking in infants with Post-menstrual age (PMA) below 32 weeks, nutritional sucking with the administration of breast milk or sweeteners above 32 weeks PMA and exposure to maternal voice. Even for parents, the experience of NICU hospitalization of their child is a particularly stressful event, mainly characterized by feelings of exclusion due to lack of interactions with their own baby due to their clinical conditions. Hence, it is very important to intervene as soon as possible on parental stress that can affect the physical and psychological quality of life of the family. This is possible through the application of nursing care plans that involve the parents in daily care and support them in the long process of development and acquisition of autonomy and skills. The nurse is a healthcare provider who has the most frequent contact with newborns hospitalized in NICU and has a key role in preventing, recognizing, and managing newborn's pain. However, there is a considerable discrepancy between the theory and practice: many nurses and doctors are aware that most of the procedures carried out in NICU cause pain. Therefore, nurses also can develop high levels of physical and psychological stress, particularly when they manage a newborn who feels pain. The purpose of this study is to evaluate if maternal involvement in the pain management of newborn admitted to NICU may reduce the level of pain perceived by infant during the heel stick procedure using the Premature Infant Pain Profile (PIPP) pain scoring tool. In addition, the study's secondary goal will be to investigate if maternal involvement in pain management of newborn may produce positive effects on the mother in reducing stress, depression and anxiety and in reducing nurses' physical and psychological stress.

The study aims to determine the effects of inhalation aromatherapy on pain and anxiety during the SWL protocol. This study included 120 patients who were scheduled to undergo SWL. Patients were randomly assigned a control placebo group 1 (n=40), the lavender group 2 (n=40), and the frankincense group 3 (n=40). The nebulizer (a rate of 2%) was prepared and operated on in the SWL room before the procedure. Data were collected using the visual analog scale (VAS) and the State Anxiety Inventory (STAI-I).

Adenotonsillectomy (AT) is one of the most common pediatric surgical procedures. The management of postoperative pain and agitation after AT is still a controversial issue. Safety considerations limit the use of opioids and non-steroidal anti-inflammatory drugs, leading to inadequate control of the high levels of postoperative pain experienced by AT patients. Along with pain killers, non-pharmacological strategies have remarkable impact on pain management in children. A systematic review and meta-analysis published in The Lancet in 2015 on adult patients suggest that auditory stimulation with music in the perioperative setting, and even when patients are under general anaesthesia, can reduce postoperative pain, anxiety, and analgesia needs. The authors concluded that there is sufficient evidence to implement auditory stimulation in the treatment of all adult surgical patients, regardless of the mode of administration. Up to now, no research has investigated the effects of intraoperative auditory stimulation on pain and agitation upon awakening after AT in the pediatric population. Objective of this study is to determine the effects of intraoperative auditory stimulation on pain and agitation upon awakening after pediatric AT.

The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.

The aim was to determine the effects of digital game play on children's pain, fear and anxiety levels during suturing. Data was obtained from 84 children between the ages of 8-17 at the Pediatric Emergency Department between 16 January and 19 March 2020, using the Socio-Demographic and Clinical Characteristics Form, the Wong-Baker Faces Pain Rating Scale (WBFPS), the Visual Analogue Scale (VAS), the Fear of Medical Procedure Scale (FMPS), and the State-Trait Anxiety Inventory for Children (STAI-CH). While the study group (n=42) played digital games during the suturing procedure, the control group (n=42) did not play digital games.

Purpose: The study was carried out to determine the effect of virtual reality applied during blood collection upon pain and anxiety in children aged 5-12. Design and Methods: In this randomized controlled study, children included in the sample group were assigned to the control group (n=43) and Aquarium VR group (n=45) using block randomization. "Child State Anxiety Scale " and "Wong-Baker Faces Pain Scale" were used to collect the data of the study. Children in the Aquarium VR group watched the "Aquarium VR" application through virtual reality glasses during the procedure. The children in the control group benefited from routine nursing services. The pain scores after blood collection and anxiety scores before and during blood collection in children in both groups were interpreted.

Venipuncture is the most frequent invasive procedure in hospitals and clinics. In the pediatric population this is very often associated with fear, anxiety, distress and enhanced perception of pain. Local anesthetic creams (like EMLA) are used to reduce pain and distress but they need 30-60 minutes of waiting between the application and the puncture, which is too much time for most of everyday life clinical contests. Many distraction techniques have been studied, both active (ie video games, virtual reality) and passive (ie listening to music, visual stimulation). Active production of music is one of the most complex activities for our central nervous system. It requires a precise timing of a lot of well-coordinated actions, like recognition and conservation of a rhythmic structure, precise execution of quick and complex fine movements, and with an important involvement of intense emotional experience. It stimulates bilaterally primary and secondary auditory cerebral areas, but also motor and premotor areas, language areas and their contralateral, cognitive areas. At the same time, it activates reward and gratification circuits with stimulation of the limbic system and endorphin release and also neurovegetative system. Music is probably the most immediate and spontaneous communication tool that can also act at subcortical level without the person being aware of what they are receiving and transmitting. Music activates the dopaminergic mesolimbic system, which regulates memory, attention, executive functions, motivation and also mood and pleasure through the nucleus accumbens. It also produces measurable cardiovascular and endocrine responses indicated by reduced serum cortisol levels and inhibition of cardiovascular stress reactions. The Leap Motion Controller is an infrared device that digitalizes the movements of the hand above it in real-time: this is connected with a software that converts this signal into a musical tone specifically set. The melody is created very easily just by moving the hand above it. With this device, children will be able to produce music without anything interposing between them and the sound production. This will allow the patient to focus only on the melodies, without technical difficulties that could derive for instance from a visual interface or an instrument you have to hold.