• 제목/요약/키워드: Pilot trial

검색결과 163건 처리시간 0.024초

Comparison of Standardized Peristomal Skin Care and Crusting Technique in Prevention of Peristomal Skin Problems in Ostomy Patients

  • Park, Seung-Mi;Lee, Yun-Jin;Oh, Doo-Nam;Kim, Ji-Yun
    • 대한간호학회지
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    • 제41권6호
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    • pp.814-820
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    • 2011
  • Purpose: This study was performed to compare the effects of standardized peristomal skin care (SPSC) and crusting technique (CT) on the peristomal skin of ostomates. SPSC was developed by a consensus among the expert group based on a comprehensive review of the relevant literature and hospital protocols. Methods: A randomized controlled pilot trial with 2 parallel arms was used. A total of 81 ostomates, who were recruited from a tertiary hospital, completed the baseline, 1-month, 2-month, and 3-month follow-up (SPSC group, n=45; CT group, n=36). SPSC consisted of water cleansing and direct application of ostomy appliances. CT involved crusting hydrocolloid powder and patting with water sponge or protective barrier liquid film. The outcomes of the study were assessed by skin problems, such as discoloration, erosion and tissue overgrowth; the domains of the evaluation tool used in examining the peristomal skin. A generalized estimating equation model was used to examine the effects according to time and group. Results: In both SPSC and CT groups, the likelihood of occurrence of discoloration (OR, 1.99; 95% CI, 1.61-2.46), erosion (OR, 1.87; 95% CI, 1.55-2.25) and tissue enlargement (OR, 1.94; 95% CI, 1.36-2.77) increased with time. There was no significant difference in discoloration between the groups, whereas the probability of erosion (OR, 0.38; 95% CI, 0.16-0.89) and tissue overgrowth (OR, 0.09; 95% CI, 0.02-0.55) was lower in the SPSC group than in CT group. Conclusion: SPSC was sufficient in preventing peristomal skin problems of ostomates compared to the CT.

Topical anesthesia for stainless steel crown tooth preparation in primary molars: a pilot study

  • Padminee, Krishnan;Hemalatha, R;Shankar, P;Senthil, D;Trophimus, Gnanabagyan J
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권4호
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    • pp.241-250
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    • 2020
  • Background: Placement of full-coverage restorations such as stainless steel crowns (SSCs) for pulpectomy treated primary molars is essential for successful outcomes. The tooth preparation process for SSCs can cause discomfort to gingival tissues since the crown should be seated 1 mm subgingivally. The purpose of this prospective trial was to compare the effectiveness of subgingival and transmucosal application of topical anesthetics on dental pain during SSC tooth preparation among 6- to 8-year-old children. Methods: A consecutive sample of 27 children, aged 6-8 years, who required an SSC after pulp therapy in primary molars were randomly divided into three groups. Group A received infiltration anesthesia before tooth preparation for SSC placement, whereas in Group B and C, only topical anesthesia was applied subgingivally and transmucosally. Wong-Bakers Faces pain rating scale (WBFPS) scores were recorded after tooth preparation. Faces, Legs, Activity, Cry and Consolability (FLACC) scores were evaluated by two blinded and calibrated investigators through video recordings of the patient during tooth preparation. Data were tabulated, and inter-group comparisons were performed using the Kruskal-Wallis and analysis of variance tests. Results: Out of the 27 participants, 48% were boys and 52% were girls, with an overall mean age of 6.83 years. Group A showed the least pain scores according to both the scales, followed by Group B and Group C. The pain intensity was statistically significant on both the pain scales with P = 0.003 for FLACC and P < 0.001 for WBFPS. Conclusion: Subgingival application of topical anesthesia reduced pain to a certain extent but not as effectively as infiltration anesthesia during SSC tooth preparation in primary molars. Transmucosal application of topical anesthesia did not reduce discomfort when compared to the other two interventions.

카페인이 HRV에 미치는 영향과 내관 자침의 효과에 대한 예비연구 : 무작위 이중맹검시험 (Short Time Effect of Caffeine on Heart Rate Variability and the Effect of Acupuncture at Neiguan (PC6): A Randomized Double Blind Pilot Study)

  • 정현숙;양창섭;남지성;장인수;김락형;서의석
    • 대한한방내과학회지
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    • 제29권3호
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    • pp.778-786
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    • 2008
  • Objectives : This study was to investigate the short time effect of caffeine on heart rate variability(HRV) and the effect of Neiguan(PC6) acupuncture stimulation on HRV. Methods : 27 healthy adult volunteers were randomly allocated to two groups: Neiguan group (N=13) or placebo group (N=14). The study was carried out under a randomized double-blinded placebo-controlled trial method. Each group orally received the same tablets with 200 mg caffeine. After 1 hour, acupuncture was applied to the Neiguan(PC6) points for the Neiguan group, and for the placebo group was applied to a non-acupuncture point. Both groups were estimated with HRV 3 times, before and after caffeine ingestion, 20 minutes after acupuncture stimulation. Results : After taking caffeine, pulse rate, mean-HRV, and pNN50(the proportion derived by dividing NN50 by the total number of NN intervals) decreased, SDNN(standard deviation of all normal-to-normal (NN) intervals), RMSSD (the root square of successive differences), TP log, HF(high frequency), and HRV index was increased. There were significant changes to the autonomic nervous system after taking caffeine. There were no significant differences between the two groups after acupuncture at Neiguan. Conclusion : Caffeine could induce general activation of the autonomic nervous system. Neiguan acupuncture stimulation may not have significant influence on the autonomic nervous system.

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문화영향평가제도 개선 방안에 관한 연구 (Study on the Ways to Improve Cultural Impact Assessment System)

  • 권기창
    • 한국콘텐츠학회논문지
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    • 제16권1호
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    • pp.415-423
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    • 2016
  • 문화영향평가는 중앙정부나 지방자치 단체가 각종 정책이나 계획 또는 사업을 수행할 때 국민의 문화환경에 영향을 미치는 부정적인 요소는 최소화 시키고 긍정적 요소는 극대화 시켜 국민의 삶의 질을 향상시키기 위한 제도로 2013년 문화기본법에 의해 도입되었다. 따라서 문화체육관광부에서는 시행착오를 줄이고 성공적인 제도로 안착시키기 위해 문화영향평가 시범사업을 추진하고 있다. 본 논문에서는 문화영향평가 제도의 성공적 안착을 위하여 선행연구, 해외 사례조사, 기타 영향평가제도 분석 등을 통해 시사점을 도출하고 도출된 시사점을 중심으로 전문가 조사를 통해 평가대상, 평가지표, 평가절차, 평가기관에 대한 개선 방안을 제시하였다. 향후 완벽한 제도로 운영되기 위해서는 평가대상의 규모, 세부 평가지표의 설정, 평가 위원회 구성 및 운영방법, 문화영향평가사 제도 도입 등에 관한 추가적인 보완 연구가 필요하다.

Chemotherapy for Malignant Gliomas Based on Histoculture Drug Response Assay : A Pilot Study

  • Gwak, Ho-Shin;Park, Hyeon-Jin;Yoo, Heon;Youn, Sang-Min;Rhee, Chang-Hun;Lee, Seung-Hoon
    • Journal of Korean Neurosurgical Society
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    • 제50권5호
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    • pp.426-433
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    • 2011
  • Objective : The Histoculture Drug Response Assay (HDRA), which measures chemosensitivity using minced tumor tissue on drug-soaked gelfoam, has been expected to overcome the limitations of in vitro chemosensitivity test in part. We analyzed interim results of HDRA in malignant gliomas to see if the test can deserve further clinical trials. Methods : Thirty-three patients with malignant gliomas were operated and their tumor samples were examined for the chemosensitivity to 10 chosen drugs by HDRA. The most sensitive chemotherapy regimen among those pre-established was chosen based on the number of sensitive drugs or total inhibition rate (IR) of the regimen. The response was evaluated by 3 month magnetic resonance image. Results : Among 13 patients who underwent total resection of the tumor, 12 showed no evidence of disease and one patient revealed progression. The response rate in 20 patients with residual tumors was 55% (3 complete and 8 partial responses). HDRA sensitivity at the cut-off value of more than one sensitive drug in the applied regimen showed a sensitivity of 100%, specificity of 60% and predictability of 70%. Another cut-off value of >80% of total IR revealed a sensitivity of 100%, specificity of 69%, and predictability of 80%. For 12 newly diagnosed glioblastoma patients, median progression-free survival of the HDRA sensitive group was 21 months, while that of the non-sensitive group was 6 months ($p$=0.07). Conclusion : HDRA for malignant glioma was inferred as a feasible method to predict the chemotherapy response. We are encouraged to launch phase 2 clinical trial with chemosensitivity on HDRA.

마황복용이 정상성인의 체중 감소와 심박변이도에 미치는 영향에 관한 예비 연구: 무작위배정 이중맹검시험 (Effects of Ephedra on Weight Loss and Heart Rate Variability: A Double-Blind Randomized Controlled Pilot Study)

  • 양창섭;형례창;여진주;서의석;장인수
    • 대한한방내과학회지
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    • 제27권4호
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    • pp.836-844
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    • 2006
  • Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

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Effects of Catgut -Embedding Therapy in Patients with Carpal Tunnel Syndrome: a Retrospective Pilot Study

  • You, Kyung-Gon;Kwon, Young-Dal
    • 대한한의학회지
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    • 제36권2호
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    • pp.43-49
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    • 2015
  • Objectives: We evaluated the effect of the traditional Korean medical therapy of catgut-embedding therapy in patients with carpal tunnel syndrome (CTS). Methods: Thirteen patients(20 hands) with CTS underwent catgut-embedding therapy once per week for a total of 1-4 sessions. We measured the time to tingling in the fingers on performing Phalen's test. We also had patients use a visual analog scale (VAS) to indicate the severity of tingling. We also asked about the awakening time at night due to pain and tingling. We controlled the treatment as being limited to four sessions. Even if a patient had not been treated for four sessions, we ended the patient's treatment if symptoms resolved. Results: Patients who received catgut-embedding therapy showed significant improvements in the clinical symptoms of CTS. After treatment, in a total of 19 hands, the status of fourteen was changed from positive to negative in Phalen's test and the average of tingling occurrence time in that test was delayed. Among the 20 hands, the VAS in eight hands changed to zero and the average of VAS score decreased. Furthermore, in nine patients, four could sleep well without the use of a splint. Conclusions: Patients undergoing this traditional Korean medical therapy showed alleviation of finger tingling after even a single treatment. We thus concluded that this traditional Korean catgut-embedding therapy, may be effective for treating CTS. However, to confirm the effects of catgut-embedding therapy on CTS, further tests are required, including under the defined, strict conditions of a randomized controlled trial.

Efficacy of Roux-en-Y Reconstruction Using Two Circular Staplers after Subtotal Gastrectomy: Results from a Pilot Study Comparing with Billroth-I Reconstruction

  • Kim, Tae-Gyun;Hur, Hoon;Ahn, Chang-Wook;Xuan, Yi;Cho, Yong-Kwan;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • 제11권4호
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    • pp.219-224
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    • 2011
  • Purpose: The Roux en Y method has rarely been performed due to longer operation time and high risk of complication, despite several merits including prevention of bile reflux. We conducted a retrospective review of the result of Roux en Y reconstruction using two circular staplers after subtotal gastrectomy. Materials and Methods: From December 2008 to May 2009, a total of 26 patients underwent Roux en Y reconstruction using two circular staplers after subtotal gastrectomy, and seventy-two patients underwent Billroth-I reconstruction. Roux en Y anastomosis was performed using two circular staplers without hand sewing anastomosis. We compared clinicopathologic features and surgical outcomes between the two groups. All patients underwent gastrofiberscopy between six and twelve months after surgery to compare the bile reflux. Results: No significant differences in clinicopathologic findings were observed between the two groups, except for the rate of minimal invasive surgery (P=0.004) and cancer stage (P=0.002). No differences in the rate of morbidity (P=0.353) and admission duration (P=0.391) were observed between the two groups. Gastrofiberscopic findings showed a significant reduction of bile reflux in the remnant stomach in the Roux en Y group (P=0.019). Conclusions: When compared with Billroth-I reconstruction, Roux en Y reconstruction using the double stapler technique was found to reduce bile reflux in the remnant stomach without increasing postoperative morbidity. Based on these results, we planned to begin a randomized controlled clinical trial for comparison of Roux en Y reconstruction using this method with Billroth-I anastomosis.

소맥글루텐과 스팀 처리가 새우 사료의 수중 안정성에 미치는 효과 (Effects of Wheat gluten and Steaming Treatment on Water Stability of Extruded Shrimp Feed)

  • 김재식
    • 한국양식학회지
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    • 제17권4호
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    • pp.282-288
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    • 2004
  • 본 연구는 새우사료의 수중 안정성을 증대시키기 위하여 실시되었다. 스팀처리도 하지 않고 글루텐도 함유하지 않은 비교시험 사료와 스팀 처리만 한 사료 그리고 소맥글루텐을 첨가하고 압출 성형한 후 스팀 처리한 사료, 세 가지 종류의 새우 사료를 제조하였다. 소맥글루텐을 새우사료에 4% (w/w) 가량 첨가하고 압출 성형한 다음 5분간 스팀 처리를 한 사료는 48시간이 지난 수중 안정성이 1로서, 소맥글루텐을 첨가하지 않고 스팀 처리도 하지 않은 비교 시험 사료의 4에 비해 수중 안정성이 크게 증가하였다. 또한 대하 사육 시험에서도 체중 증가율과 사료 효율이 각각 237%, 16.7%로서 비교 시험 사료의 151%, 12.8%보다 그 수치가 크게 증가하였다. 소맥글루텐의 첨가량과 스팀 처리 시간을 변화시켜 본 결과 소맥글루텐 첨가량을 4∼8%(w/w), 스팀 처리시간은 5∼10분으로 하는 것이 새우사료의 수중 안정성 개선에 적당한 것으로 나타났다.

Eye Movement Program Consisting of Saccadic Eye Movement and Pursuit Eye Movement Improved Visual Memory in Institutionalized Elderly Person: Randomized controlled pilot study

  • Park, Yongnam;Bae, Youngsook
    • 국제물리치료학회지
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    • 제10권2호
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    • pp.1768-1773
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    • 2019
  • Background: Aging reduces cognitive abilities, including visual memory (VM) and visual discrimination (VD). Since common cortical networks subserve eye movement and attention, voluntary eye movement may improve visual attention. Visual selective attention was major role for memory, and visual memory and visual attention are intimately related. Objective: To identify the improvement in VD and VM, after implementing the eye movement program consisting of saccadic eye movement (SEM) and pursuit eye movement (PEM) in the institutionalized healthy elderly. Design: Randomized controlled trial. Methods: The study involved a sample of 36 participants, and the mean age was 79.03 years (range 76~84 years). They were randomly allocated to the experimental group (n=16) and control group (n=20). Participants in the experimental group performed SEM 5 times per week for 4 weeks: twice daily at the same time in the morning and afternoon. The program was carried out for 3 minutes, and it consisted of SEM and PEM. The target's moving frequency was set at 0.5 Hz. VM and VD at the baseline and post-intervention were measured using Motor-Free Visual Perception test-4 (MFVPT-4). Results: VM significantly improved in the experimental group (p < .01), and significant differences were observed compared to the control group (p < .01). There was no significant change in VD. Conclusion: The eye movement program consisting of SEM and PEM increased VM more than VD. Therefore, eye movement program was feasible interventions for improving VM in institutionalized elderly persons.