scholarly journals Effect of music on pediatric endoscopic examinations: a randomized controlled trial

2021 ◽  
Vol 09 (04) ◽  
pp. E599-E605
Author(s):  
Constanza Bay ◽  
Romina Henriquez ◽  
Luis Villarroel ◽  
Juan Cristóbal Gana
Keyword(s):  
Randomized Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Family Satisfaction ◽  
Anxiety Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Study Results ◽  
Patient Reported ◽  
Experimental Group

Abstract Background and study aims The primary objective was to measure the effect of music as an adjunct to sedation in patient anxiety levels during pediatric endoscopic examinations. Patients and methods We performed a single-blind randomized controlled trial comparing music with no music in children aged 2 to 18 years. Anxiety was measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Anxiety Scale (VAS-anxiety). Patient perception of pain was evaluated with the Wong-Baker Faces Pain Rating Scale (WBFPRS). Patient experience, family satisfaction, and endoscopist perception of difficulty were evaluated. Sedative doses were recorded. Results A total of 51 children were randomized to the experimental group and 49 children to the control group. The mean ages were 10.5 years and 12.3 years, respectively. There were 63 % female subjects with no differences between groups. Overall, there were 85 upper endoscopies and 15 colonoscopies. In the recovery unit, the experimental group had lower average m-YPAS scores (mean score 27.7 vs 34.7; P < 0.001), a higher proportion of them had low m-YPAS scores (80 % vs 49 % P < 0.001), had lower VAS-anxiety scores [mean score 0.55 vs 1.57 (P = 0.003)], and had lower WBFPRS scores [mean score 2.7 vs 1.3 (P = 0.001)]. There were no statistically significant differences found in the amount of standard sedation given to the groups, nor in additional sedation administered. In the experimental group, the patient-reported experience was significantly better. Conclusions The study results show that music reduces anxiety and pain associated with endoscopic procedures in children. It also facilitates these procedures and improves patient satisfaction.

scholarly journals Intensive Motion Style Acupuncture Treatment (MSAT) Is Effective for Patients with Acute Whiplash Injury: A Randomized Controlled Trial

2020 ◽  
Vol 9 (7) ◽  
pp. 2079
Author(s):  
Doori Kim ◽  
Kyoung-Sun Park ◽  
Jin-Ho Lee ◽  
Won-Hyung Ryu ◽  
Heeyoung Moon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Whiplash Injury ◽  
Rating Scale ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Rank Test ◽  
Control Group ◽  
Korean Medicine ◽  
Randomized Controlled ◽  
Motion Style

In this single-center, parallel, randomized controlled trial, we aim to examine the effects and safety of motion style acupuncture treatment (MSAT; a combination of acupuncture and Doin therapy) on pain reduction and functional improvement in patients with whiplash-associated disorders (WADs). Ninety-seven patients with cervical pain admitted to the Bucheon Jaseng Hospital of Korean Medicine, South Korea, due to acute whiplash injury were treated with integrative Korean medicine (IKM) with (MSAT group, 48 patients) or without (control group, 49 patients) an additional 3-day MSAT during hospitalization (5–14 days) and followed-up for 90 days. The mean numeric rating scale (NRS) scores of the MSAT and control groups at baseline were 5.67 (95% confidence interval (CI), 5.33, 6.01) and 5.44 (95% CI, 5.06, 5.82), respectively, and on day 5, 3.55 (95% CI, 3.04, 4.06) and 4.59 (95% CI, 4.10–5.07), respectively. The NRS change difference between the groups was −1.07 (95% CI, −1.76, −0.37). The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test p = 0.0055). IKM treatment combined with MSAT may be effective in reducing the pain and improving the range of motion in patients with WADs.

scholarly journals A Non-Randomized Controlled Trial for the Effectiveness of the ‘Aibo’ Intervention Program for Distraction in Childhood Vaccination

2021 ◽  
Author(s):  
Kyoko Tanaka ◽  
Maoko Hayakawa ◽  
Chihiro Noda ◽  
Moemi Nakamura ◽  
Akio Nakamura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioral Observation ◽  
Childhood Vaccination ◽  
Control Group ◽  
Randomized Controlled ◽  
Study Results ◽  
Face Scale

Abstract Procedures and actions such as injections and immobilization cause pain and distress to children. In the pediatric field, there is a need for interventions and support to alleviate the pain and distress caused by such medical procedures. In recent years, the introduction of robots as a means of distraction has begun to be attempted. In this study, we conducted a non-randomized controlled trial to examine the effect of intervention using ‘aibo’, a dog-like robot which has artificial intelligence (AI), to promote distraction in children after vaccination. As a result, 57 children (32 in the intervention group) participated in the study. Results of a t-test with the control group showed that the intervention group using aibo had significantly less pain following the post-vaccination intervention than the control group using stuffed dog (Face Scale, t(55) = 2.582, p = .0125; Behavioral Observation Scale, t(55) = 2.772, p = .00759). The results support the hypothesis that the aibo intervention group will be less distressed and able to calm down more quickly after vaccination than the control group. Conclusion : AI-powered aibo interventions that allow for interactive interaction can be an effective distraction method during painful procedures such as vaccinations.

scholarly journals Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

Testing the Effectiveness of a Strengths-Based Intervention Targeting All 24 Strengths: Results From a Randomized Controlled Trial

2020 ◽  
pp. 003329412093744
Author(s):  
Lobna Chérif ◽  
Valerie M. Wood ◽  
Christian Watier
Keyword(s):  
Randomized Controlled Trial ◽  
Character Strengths ◽  
Controlled Trial ◽  
Control Group ◽  
Strength Development ◽  
Character Strength ◽  
Significant Group ◽  
Randomized Controlled ◽  
Time Interaction ◽  
Experimental Group

This study assessed the effectiveness of a strengths-based randomized controlled trial focused on fostering all 24 character strengths in a group of 75 participants from a University in Tunisia. Participants randomly assigned to the challenge condition (n = 40) received an email each day for 24 days, that highlighted a particular strength of the day including why the strength is valuable, how to implement the strength behaviourally, and a motto related to that strength. Those in the control condition (n = 35) simply received emails containing the motto for each strength daily for 24 days. We assessed all participants’ levels of happiness before the experiment (T0), the day following the experiment (T1), and one-month following the experiment (T2). Results from a 2 (group) X 3 (time) split plot ANOVA revealed a significant group-by-time interaction, such that at T2 the experimental group had greater happiness scores than the control group. These findings provide some evidence that even “minimalist” interventions (involving the receipt of emails encouraging character-strength development), might be effective for promoting gains in happiness even one month after the intervention.

scholarly journals Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

2020 ◽  
Vol 17 (7) ◽  
pp. 2465
Author(s):  
Alfonso Javier Ibáñez-Vera ◽  
Jerónimo Carmelo García-Romero ◽  
José Ramón Alvero-Cruz ◽  
Rafael Lomas-Vega
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sham Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Physical Factor ◽  
Control Group ◽  
Local Pain ◽  
Randomized Controlled ◽  
Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

scholarly journals Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Mastour Saeed Alshahrani ◽  
Jaya Shanker Tedla ◽  
Ravi Shankar Reddy ◽  
Faisal Asiri
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Disability ◽  
Sf 36 ◽  
Neck Disability ◽  
Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

scholarly journals Effects of an Interactive Computer Game Exercise Regimen on Balance Impairment in Frail Community-Dwelling Older Adults: A Randomized Controlled Trial

2011 ◽  
Vol 91 (10) ◽  
pp. 1449-1462 ◽  
Author(s):  
Tony Szturm ◽  
Aimee L. Betker ◽  
Zahra Moussavi ◽  
Ankur Desai ◽  
Valerie Goodman
Keyword(s):  
Randomized Controlled Trial ◽  
Video Game ◽  
Dynamic Balance ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Control Group ◽  
Day Hospital ◽  
Randomized Controlled ◽  
Balance Exercises ◽  
Experimental Group

Background Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. Objectives The purpose of this study was to examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Design This study was a randomized controlled trial. Setting The study was conducted in a geriatric day hospital. Participants Thirty community-dwelling and ambulatory older adults attending the day hospital for treatment of balance and mobility limitations participated in the study. Interventions Participants were randomly assigned to either a control group or an experimental group. The control group received the typical rehabilitation program consisting of strengthening and balance exercises provided at the day hospital. The experimental group received a program of dynamic balance exercises coupled with video game play, using a center-of-pressure position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface, with progression to a compliant sponge pad. Each group received 16 sessions, scheduled 2 per week, with each session lasting 45 minutes. Measurements Data for the following measures were obtained before and after treatment: Berg Balance Scale, Timed “Up & Go” Test, Activities-specific Balance Confidence Scale, modified Clinical Test of Sensory Interaction and Balance, and spatiotemporal gait variables assessed in an instrumented carpet system test. Results Findings demonstrated significant improvements in posttreatment balance performance scores for both groups, and change scores were significantly greater in the experimental group compared with the control group. No significant treatment effect was observed in either group for the Timed “Up & Go” Test or spatiotemporal gait variables. Limitations The sample size was small, and there were group differences at baseline in some performance measures. Conclusion Dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This coupling, in turn, resulted in a greater improvement in dynamic standing balance control compared with the typical exercise program. However, there was no transfer of effect to gait function.

scholarly journals A Randomized Controlled Trial of a Passive Accessory Joint Mobilization on Acute Ankle Inversion Sprains

2001 ◽  
Vol 81 (4) ◽  
pp. 984-994 ◽  
Author(s):  
Toni Green ◽  
Kathryn Refshauge ◽  
Jack Crosbie ◽  
Roger Adams
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Step Length ◽  
Control Group ◽  
Joint Mobilization ◽  
Randomized Controlled ◽  
Ankle Inversion ◽  
Before And After ◽  
Experimental Group ◽  
Support Time

Abstract Background and Purpose. Passive joint mobilization is commonly used by physical therapists as an intervention for acute ankle inversion sprains. A randomized controlled trial with blinded assessors was conducted to investigate the effect of a specific joint mobilization, the anteroposterior glide on the talus, on increasing pain-free dorsiflexion and 3 gait variables: stride speed (gait speed), step length, and single support time. Subjects. Forty-one subjects with acute ankle inversion sprains (&lt;72 hours) and no other injury to the lower limb entered the trial. Methods. Subjects were randomly assigned to 1 of 2 treatment groups. The control group received a protocol of rest, ice, compression, and elevation (RICE). The experimental group received the anteroposterior mobilization, using a force that avoided incurring any increase in pain, in addition to the RICE protocol. Subjects in both groups were treated every second day for a maximum of 2 weeks or until the discharge criteria were met, and all subjects were given a home program of continued RICE application. Outcomes were measured before and after each treatment. Results. The results showed that the experimental group required fewer treatment sessions than the control group to achieve full pain-free dorsiflexion. The experimental group had greater improvement in range of movement before and after each of the first 3 treatment sessions. The experimental group also had greater increases in stride speed during the first and third treatment sessions. Discussion and Conclusion. Addition of a talocrural mobilization to the RICE protocol in the management of ankle inversion injuries necessitated fewer treatments to achieve pain-free dorsiflexion and to improve stride speed more than RICE alone. Improvement in step length symmetry and single support time was similar in both groups.

Randomized Controlled Trial of a Cognitive Narrative Crisis Intervention for Bereavement in Primary Healthcare

2016 ◽  
Vol 45 (1) ◽  
pp. 85-90 ◽  
Author(s):  
Ana Sofia Andrade ◽  
Margarida Moreira ◽  
Mónica Sá ◽  
Duarte Pacheco ◽  
Vera Almeida ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Traumatic Stress ◽  
Controlled Trial ◽  
Cost Effective ◽  
Structured Interview ◽  
Control Group ◽  
Randomized Controlled ◽  
Demographic Questionnaire ◽  
The Impact ◽  
Experimental Group

Background and Aims: As there are known risks of retraumatization through bereavement crisis interventions, we tailored a new intervention lowering the degree of direct emotional activation. However, we need some evidence on the effects of depression and psychotraumatic symptoms between 1 and 6 months after a loss. Method: We conducted a randomized controlled trial with two groups: control group (n = 18) and experimental group (n = 11) in two assessments (1 and 6 months after loss); both included a semi-structured interview (Socio-Demographic Questionnaire, Beck Depression Inventory and the Impact of Events Scale-Revised–IES-R). The experimental group had a cognitive-narrative program with four sessions: recalling; cognitive and emotional subjectivization; metaphorization; and projecting sessions. Results: Participants in the experimental and control groups have lower levels of depression and traumatic stress 6 months after a loss. Statistically significant results in emotional numbing IES-R sub-scale are observed. Conclusions: A brief narrative-based cost-effective intervention has a positive effect on depression, controlling the traumatic stress and time after a loss.

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