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"Physical Stimulation"
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Automated tactile stimulation in response to cardiorespiratory events in preterm infants: a feasibility study
ObjectiveAssess the feasibility and safety of a purpose-built automated tactile stimulation device (ATSD) responding to cardiorespiratory events in preterm infants.DesignRandomised cross-over study.SettingLevel-III neonatal intensive care unit in the Netherlands.PatientsInfants born between 24 and 30 weeks gestational age, receiving non-invasive respiratory support and experiencing apnoea, bradycardia and/or hypoxia for>10 s.InterventionsInfants underwent two study periods of 24 hours. In the control period, the ATSD was attached but inactive. In the intervention period, ATSD was activated and used in addition to standard care, providing direct vibratory stimulation in response to clinical alarms.Main outcome measureFeasibility of using ATSD, expressed by the number of infants completing the study, the ability to provide stimulation on the skin and the perceived feasibility by the nurses.Results16 infants were included, of which 14 (88%) completed both study periods. Two infants were withdrawn from the study prematurely: one infant required intubation for cyanotic spells and the other developed local non-blanching erythema consistent with a mild pressure ulcer, on which the device was removed. During the intervention period, ATSD correctly detected 84% of the cardiorespiratory events, with automatic stimulation following 100% of the events. Nurses found the ATSD easy to use and rated the clinical utility neutral to positive.ConclusionApplying automated tactile stimulation in preterm infants using a purpose-built device is feasible, was well tolerated by infants and nurses considered our device useful and easy to use.Trial registration detailsDutch national trial register, NL9606.
Journal Article
A Randomized, Crossover Trial of a Novel Sound-to-Sleep Mattress Technology in Children with Autism and Sleep Difficulties
Study Objectives:
This preliminary study investigated the tolerability and efficacy of a novel mattress technology—the Sound-To-Sleep (STS) system—in the treatment of sleep problems in children with autism.
Methods:
After screening, 45 children, ages 2.5 to 12.9 years, were randomized to order of mattress technology use (On-Off vs. Off-On). Treatment conditions (On vs. Off) lasted two weeks with immediate crossover. Tolerability, including study discontinuation and parent-report of mattress tolerance and ease of use, was tracked throughout the study. Efficacy assessments were obtained at baseline, prior to crossover, and end of study and included measures of autism traits, other psychopathology symptoms, sensory abnormalities, communication difficulties, quality of life, sleep diary parameters, and single-blinded actigraphy-derived sleep parameters. Statistical analyses evaluated differences in tolerability and efficacy when the STS system was on versus off.
Results:
STS system use was well tolerated (n = 2, 4.4% dropout) and resulted in parent-reported sleep quality improvements (STS off mean = 4.3, 95% CI = 4.05–4.54 vs. on mean = 4.9, 95%CI = 4.67–5.14). The technology was described by parents as very easy to use and child tolerance was rated as good. Parent-diary outcomes indicated improvements in falling asleep and reduced daytime challenging behavior. Actigraphy-derived sleep parameters indicated improved sleep duration and sleep efficiency. Improvements in child and family quality of life were identified on parent questionnaires.
Conclusions:
A future large sample phase 2 trial of the STS system is warranted and would benefit from extended study duration, an objective primary efficacy outcome, and careful attention to methodological issues that promote compliance with the intervention and study procedures.
Citation:
Frazier TW, Krishna J, Klingemier E, Beukemann M, Nawabit R, Ibrahim S. A randomized, crossover trial of a novel sound-to-sleep mattress technology in children with autism and sleep difficulties.
J Clin Sleep Med
. 2017;13(1):95–104.
Journal Article
Comparison of three methods of penile vibratory stimulation for semen retrieval in men with spinal cord injury
Study design:
Prospective, three-way crossover design.
Objective:
Penile vibratory stimulation (PVS) is recommended as the first line of treatment for semen retrieval in anejaculatory men with spinal cord injury (SCI). This study compared ejaculatory success rates and patient preference for three methods of PVS within the same group of men with SCI.
Setting:
Major medical university.
Methods:
Fifteen men with SCI each received three methods of PVS. Method 1 (M1): applying one FertiCare Personal device to the dorsum or frenulum of the glans penis; Method 2 (M2): ‘sandwiching’ the glans penis between two FertiCare devices; Method 3 (M3): sandwiching the glans penis between the two vibrating surfaces of the Viberect-X3 device. The order of M1, M2 and M3 was varied to control for sequencing effects. Following each PVS trial, subjects rated their experience on a questionnaire with scaled responses.
Results:
Ejaculation success rates were high for each method; however, ejaculation latency was significantly longer with M3 compared with M1 or M2. In survey questions about patient preference, there were no significant differences between M1 and M2. In contrast, M3 was rated lower than M1 and M2 in patient preference. Semen collection may be more difficult with the Viberect device.
Conclusions:
On the basis of these findings, we recommend attempting PVS with one FertiCare device. If that fails, use two FertiCare devices. Although the Viberect-X3 was preferred less by patients, it had similar efficacy as the Ferticare vibrator(s) and may be suitable for home use by some patients.
Journal Article
Faster clean catch urine collection (Quick-Wee method) from infants: randomised controlled trial
Objective To determine if a simple stimulation method increases the rate of infant voiding for clean catch urine within five minutes.Design Randomised controlled trial.Setting Emergency department of a tertiary paediatric hospital, Australia.Participants 354 infants (aged 1-12 months) requiring urine sample collection as determined by the treating clinician. 10 infants were subsequently excluded.Interventions Infants were randomised to either gentle suprapubic cutaneous stimulation (n=174) using gauze soaked in cold fluid (the Quick-Wee method) or standard clean catch urine with no additional stimulation (n=170), for five minutes.Main outcome measures The primary outcome was voiding of urine within five minutes. Secondary outcomes were successful collection of a urine sample, contamination rate, and parental and clinician satisfaction with the method.Results The Quick-Wee method resulted in a significantly higher rate of voiding within five minutes compared with standard clean catch urine (31% v 12%, P<0.001), difference in proportions 19% favouring Quick-Wee (95% confidence interval for difference 11% to 28%). Quick-Wee had a higher rate of successful urine sample collection (30% v 9%, P<0.001) and greater parental and clinician satisfaction (median 2 v 3 on a 5 point Likert scale, P<0.001). The difference in contamination between Quick-Wee and standard clean catch urine was not significant (27% v 45%, P=0.29). The number needed to treat was 4.7 (95% confidence interval 3.4 to 7.7) to successfully collect one additional urine sample within five minutes using Quick-Wee compared with standard clean catch urine.Conclusions Quick-Wee is a simple cutaneous stimulation method that significantly increases the five minute voiding and success rate of clean catch urine collection.Trial registration Australian New Zealand Clinical Trials Registry ACTRN12615000754549.
Journal Article
Acute tryptophan depletion alters affective touch perception
RationaleAffiliative tactile interactions help regulate physiological arousal and confer resilience to acute and chronic stress. C-tactile afferents (CTs) are a population of unmyelinated, low threshold mechanosensitive cutaneous nerve fibres which respond optimally to a low force stimulus, moving at between 1 and 10 cm/s. As CT firing frequencies correlate positively with subjective ratings of touch pleasantness, they are hypothesised to form the first stage of encoding affiliative tactile interactions. Serotonin is a key modulator of social responses with known effects on bonding.ObjectivesThe aim of the present study was to determine the effect of acutely lowering central serotonin levels on perceptions of CT-targeted affective touch.MethodsIn a double blind, placebo-controlled design, the effect of acute tryptophan depletion (ATD) on 25 female participants’ ratings of directly and vicariously experienced touch was investigated. Psychophysical techniques were used to deliver dynamic tactile stimuli; some velocities were targeted to optimally activate CTs (1–10 cm/s), whereas other, faster and slower strokes fell outside the CT optimal range. Discriminative tactile function, cold pain threshold and tolerance were also measured.ResultsATD significantly increased pleasantness ratings of both directly and vicariously experienced affective touch, increasing discrimination of the specific hedonic value of CT targeted velocities. While ATD had no effect on either tactile or cold pain thresholds, there was a trend for reduced tolerance to cold pain.ConclusionsThese findings are consistent with previous reports that depletion of central serotonin levels modulates neural and behavioural responsiveness to appetitive sensory signals.
Journal Article
Using Buzzy, Shotblocker, and Bubble Blowing in a Pediatric Emergency Department to Reduce the Pain and Fear Caused by Intramuscular Injection: A Randomized Controlled Trial
Procedural pain in general, and intramuscular (IM) injection pain in particular, is one of the most distressing and painful health care experiences for children. Pharmacologic and nonpharmacologic methods are used as forms of pain control for children undergoing acute painful interventions in emergency departments.
This study was a prospective, randomized controlled trial. The sample consisted of children aged 5 to 10 years old who required IM injections. Children were placed in 4 subgroups through randomization, using a computer program: the Buzzy (MMJ Labs. Atlanta, GA) group (n = 40), the ShotBlocker (Bionix Development Corporation, Toledo, OH) group (n = 40), the bubble-blowing group (n = 40), and the control group (n = 40). Immediately before and after the injection, the children, their parents, and an observer were asked to evaluate the child’s level of fear. The Oucher scale was also employed by the observers, children, and parents immediately after the procedure to assess the level of pain in the children in each group.
No statistically significant difference was determined between the control and intervention groups in terms gender, age, previous pain experienced with injection, the parent who was with the child, the parent’s age. A significant difference was found between the intervention and control groups in terms of levels of pain and fear during IM injection. Pain and fear were notably less in the group of children receiving the Buzzy intervention.
The Buzzy intervention should be used when children are undergoing IM injections to reduce their levels of pain and fear.
Journal Article
Effect of an oral stimulation protocol on breastfeeding among preterm infants: a randomised controlled trial
ObjectivesThe objectives are to assess the effectiveness of a modified and adapted oral sensorimotor intervention (MA-OSMI) protocol for infants in India on the rate and performance of breastfeeding among preterm (PT) infants at discharge.DesignSingle-centre randomised control trial.SettingLevel III B neonatal intensive care unit in a quaternary care hospital in South India.PatientsA total of 76 PT infants born between 26 and 33+6 weeks of gestational age, stratified into <30 weeks and 30–33+6 weeks, were randomised to intervention group (MA-OSMI) or standard care (SC).InterventionsMA-OSMI in addition to SC versus SC alone. The stimulation included 12 techniques administered by the principal investigator. SC included kangaroo mother care and non-nutritive sucking.Outcome measuresExclusive breastfeeding (EBF) rate and breastfeeding performance at the time of discharge, assessed using standardised tools by clinician and mothers.ResultsInfants in MA-OSMI group (66%) had significantly higher EBF rate compared with the SC group (16%) (OR: 10.25; 95% CI: 3.41 to 30.80). Improved breastfeeding performance was noted as per the clinician’s observation. Significantly lower scores for MA-OSMI groups (63.42±36.43) than SC groups (126.61±60.94) on mothers’ ratings suggested better feeding skills.ConclusionPrefeeding oral stimulation contributed significantly to the achievement of EBF among PT infants at discharge. The present findings may benefit speech–language pathologists, paediatricians/neonatologists and nurses in the intervention of oral feeding among neonates.
Journal Article
The influence of vibration type, frequency, body position and additional load on the neuromuscular activity during whole body vibration
This study aimed to assess the influence of different whole body vibration (WBV) determinants on the electromyographic (EMG) activity during WBV in order to identify those training conditions that cause highest neuromuscular responses and therefore provide optimal training conditions. In a randomized cross-over study, the EMG activity of six leg muscles was analyzed in 18 subjects with respect to the following determinants: (1) vibration type (side-alternating vibration (SV) vs. synchronous vibration (SyV), (2) frequency (5–10–15–20–25–30 Hz), (3) knee flexion angle (10°–30°–60°), (4) stance condition (forefoot vs. normal stance) and (5) load variation (no extra load vs. additional load equal to one-third of the body weight). The results are: (1) neuromuscular activity during SV was enhanced compared to SyV (
P
< 0.05); (2) a progressive increase in frequency caused a progressive increase in EMG activity (
P
< 0.05); (3) the EMG activity was highest for the knee extensors when the knee joint was 60° flexed (
P
< 0.05); (4) for the plantar flexors in the forefoot stance condition (
P
< 0.05); and (5) additional load caused an increase in neuromuscular activation (
P
< 0.05). In conclusion, large variations of the EMG activation could be observed across conditions. However, with an appropriate adjustment of specific WBV determinants, high EMG activations and therefore high activation intensities could be achieved in the selected muscles. The combination of high vibration frequencies with additional load on an SV platform led to highest EMG activities. Regarding the body position, a knee flexion of 60° and forefoot stance appear to be beneficial for the knee extensors and the plantar flexors, respectively.
Journal Article
Improved Anatomical Specificity of Non-invasive Neuro-stimulation by High Frequency (5 MHz) Ultrasound
Low frequency ultrasound (<1 MHz) has been demonstrated to be a promising approach for non-invasive neuro-stimulation. However, the focal width is limited to be half centimeter scale. Minimizing the stimulation region with higher frequency ultrasound will provide a great opportunity to expand its application. This study first time examines the feasibility of using high frequency (5 MHz) ultrasound to achieve neuro-stimulation in brain and verifies the anatomical specificity of neuro-stimulation
in vivo
. 1 MHz and 5 MHz ultrasound stimulation were evaluated in the same group of mice. Electromyography (EMG) collected from tail muscles together with the motion response videos were analyzed for evaluating the stimulation effects. Our results indicate that 5 MHz ultrasound can successfully achieve neuro-stimulation. The equivalent diameter (ED) of the stimulation region with 5 MHz ultrasound (0.29 ± 0.08 mm) is significantly smaller than that with 1 MHz (0.83 ± 0.11 mm). The response latency of 5 MHz ultrasound (45 ± 31 ms) is also shorter than that of 1 MHz ultrasound (208 ± 111 ms). Consequently, high frequency (5 MHz) ultrasound can successfully activate the brain circuits in mice. It provides a smaller stimulation region, which offers improved anatomical specificity for neuro-stimulation in a non-invasive manner.
Journal Article