• Title/Summary/Keyword: non-randomized controlled trial

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A comparative study of immediate wound healing complications following cleft lip repair using either absorbable or non-absorbable skin sutures

  • Alawode, Akeem O.;Adeyemi, Michael O.;James, Olutayo;Ogunlewe, Mobolanle O.;Butali, Azeez;Adeyemo, Wasiu L.
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.44 no.4
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    • pp.159-166
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    • 2018
  • Objectives: The aim of the study was to compare wound healing complications following the use of either absorbable or non-absorbable sutures for skin closure in cleft lip repair. Materials and Methods: This was a randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Lagos University Teaching Hospital, Idi Araba, Lagos State, Nigeria. Sixty subjects who required either primary or secondary cleft lip repair and satisfied all the inclusion criteria were recruited and randomized into two groups (Vicryl group or Nylon group). The surgical wounds in all subjects were examined on 3rd, 7th, and 14th postoperative days (POD) for presence or absence of tissue reactivity, wound dehiscence, and local wound infection. Results: Hemorrhage, tissue reactivity, wound dehiscence, and local wound infection were identified as wound healing complications following cleft lip repair. The incidence of postoperative wound healing complications on POD3 was 33.3%. Tissue reactivity was more common throughout the evaluation period with the use of an absorbable (Vicryl) suture compared to a non-absorbable (Nylon) suture, although the difference was statistically significant only on POD7 (P=0.002). There were no significant differences in the incidences of wound dehiscence and infection between the two groups throughout the observation period. Conclusion: There were no statistically significant differences in the incidences of wound dehiscence and surgical site wound infection following the use of either Vicryl or Nylon for skin closure during cleft lip repair. However, more cases of tissue reactivity were recorded in the Vicryl group than in the Nylon group on POD7. Particular attention must be paid to detect the occurrence of wound healing complications, most especially tissue reactivity, whenever a Vicryl suture is used for skin closure in cleft lip repair.

Applying Clinical Judgment Rubric for Evaluation of Simulation Practice for Nursing Students : A Non-Randomized Controlled Trial

  • Kim, Hyun-Ju
    • International Journal of Contents
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    • v.14 no.2
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    • pp.35-40
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    • 2018
  • The purpose of this study is to investigate the effects of debriefing using Lasater's Clinical Judgment Rubric to study nursing students' academic self-efficacy, clinical performance, and clinical judgment. The experiment group was subjected to debriefing by applying the Clinical Judgment Rubric, while general debriefing was applied to the control group. The results of the study are as follows: Clinical judgment scores were improved after debriefing for both groups, significantly higher for students in the experimental group compared to the control group. However, there was no significant difference between the two groups in academic self-efficacy or clinical performance. In conclusion, the debriefing based on the Clinical Judgment Rubric used in this study proved to be effective in improving the clinical judgment of nursing students.

Effects of Wearable Near-Infrared Rays on Knee Pain in Korean Elderly Adults

  • Lee, Jin-Min;Kim, Kye-Ha
    • Journal of Integrative Natural Science
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    • v.13 no.4
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    • pp.121-127
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    • 2020
  • To investigate the effects of wearable near-infrared ray-emitting knee pads on knee pain among elderly adults in Korea. Randomized controlled trial evaluating the effects of near-infrared rays (NIR) on knee pain in Korean elderly adults. Five community-based research facilities (two welfare centers, a senior citizen center, and two churches). Forty-seven participants aged 65 years and older who had experienced knee pain. The experimental group (n = 25) wore NIR-emitting knee pads for one month at nighttime while sleeping. The control group (n = 22) wore knee pads without NIR. Demographic characteristics, intensity and duration of knee pain, amount of analgesic medication used, range of motion, gait speed, and health-related quality of life were collected using questionnaires. The experimental group showed decreased intensity (t = -6.17, p < 0.001) and duration (t = -3.34, p = 0.002) of knee pain and reduced analgesic use (t = -2.30, p = 0.026) compared to the control group. NIR may be an effective non-pharmacological option for relieving knee pain in elderly adults.

Effects of Laughter Therapy on Depression and Sleep Wake Disorders of the Elderly in Residential Facilities : A Systematic Review and Meta-analysis (웃음요법이 시설거주 노인의 우울과 수면 장애에 미치는 효과 : 체계적 고찰 및 메타분석)

  • Kim, Eun-Jung;Yang, Jin-Hyang
    • Journal of Korea Entertainment Industry Association
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    • v.15 no.8
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    • pp.291-303
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    • 2021
  • The purpose of this study is to identify the effects of laughter therapy on depression and sleep wake disorders among the elderly in residential facilities using a systemic review and meta-analysis. Twelve databases were searched. Two researchers independently performed the selection of the studies, data coding and assessment. The risk of bias was assessed using risk of bias (RoB) and risk of bias assessment tool for non-randomized studies (RoBANs). To estimate the effect size, meta-analysis of the studies was performed using R version 4.04. Out of the 1,122 retrieved articles, one randomized controlled trial (RCT) and eleven non-randomized controlled trials (non-RCTs) were selected for analysis. The overall effect size of eleven studies on depression was determined to be -1.04 (95% Cl: -1.53~-0.54, p<.001). There were statistically significant in the effect of below ten sessions and the effect of below 400 minutes'and 400 to 1000 minutes'interventions on depression. The overall effect size of five studies on sleep wake disorders was 0.83 (95% Cl: -0.26~1.93, p=.136), which was not statistically significant. There was statistically significant in the effect of below 300 minutes'interventions on sleep wake disorders. Laughter therapy was an effective non-pharmacological intervention to reduce depression among the elderly in residential facilities. The findings also suggest that guidelines for laughter therapy need to be developed considering the number of sessions and a duration of intervention to reduce depression and sleep wake disorders of the elderly in residential facilities.

Comparison of Sensorimotor Training using Chin-Tuck Exercise with Therapeutic Stretching Training on Neck Pain and Mobility in Individuals with Chronic Non-Specific Neck Pain: A pilot randomized controlled trial

  • Kim, Chang-Yong;Kim, Hyeong-Dong
    • Journal of the Korean Society of Physical Medicine
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    • v.14 no.2
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    • pp.29-40
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    • 2019
  • PURPOSE: Despite the widespread occurrence in the general population, few studies have directly evaluated the effects of shingles on non-specific neck pain (NSNP). This study investigated whether sensory training or therapeutic stretching exercises are more effective in increasing neck mobility and reducing neck pain in chronic NSNP patients. METHODS: Eighty-one subjects aged between 20 and 32 years with chronic neck pain (> six months), were allocated randomly to three groups: sensorimotor training group (STG), therapeutic stretching group (TSG), and home exercise group (HEG). All participants received a half-hour training session, three times weekly for six weeks. The outcomes were evaluated using the neck disability index for measuring neck pain, and a universal goniometer to measure the cervical passive range of motion before and after the six-week intervention. RESULTS: The post-test neck disability index scores in the STG (t = 4.86) and TSG (t = 3.24) were decreased significantly (p < .05). The passive range of motion changes in all cervical movements in the STG was increased significantly (p < .05) after intervention compared to those in the other two groups. CONCLUSION: Sensorimotor training using chin tuck exercises may improve neck pain and mobility in subjects with chronic NSNP.

Chronic non-bacterial osteomyelitis in the jaw

  • Kim, Soung Min;Lee, Suk Keun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.45 no.2
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    • pp.68-75
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    • 2019
  • Chronic recurrent multifocal osteomyelitis (CRMO) is one of the most severe form of chronic non-bacterial osteomyelitis (CNO), which could result in bone and related tissue damage. This autoinflammatory bone disorder (ABD) is very difficult for its clinical diagnosis because of no diagnostic criteria or biomarkers. CRMO in the jaw must be suspected in the differential diagnosis of chronic and recurrent bone pain in the jaw, and a bone biopsy should be considered in chronic and relapsing bone pain with swelling that is unresponsive to treatment. The early diagnosis of CRMO in the jaw will prevent unnecessary and prolonged antibiotic usage or unnecessary surgical intervention. The updated researches for the identification of genetic and molecular alterations in CNO/CRMO should be studied more for its correct pathophysiological causes and proper treatment guidelines. Although our trial consisted of reporting items from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), there are very few articles of randomized controlled trials. This article was summarized based on the author's diverse clinical experiences. This paper reviews the clinical presentation of CNO/CRMO with its own pathogenesis, epidemiology, recent research studies, and general medications. Treatment and monitoring of the jaw are essential for the clear diagnosis and management of CNO/CRMO patients in the field of dentistry and maxillofacial surgery.

Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: A Randomized Controlled Pilot Trial (폐경 후 고혈압 전단계 및 1기 고혈압에 대한 침 치료 효과: 무작위 대조 예비연구)

  • Kim, Jung-Eun;Choi, Sun-Mi;Choi, Jin-Bong;Kim, Hyeong-Jun;Kwon, Ojin;Kim, Jae-Hong;Park, Ji-Eun
    • Korean Journal of Acupuncture
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    • v.34 no.3
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    • pp.116-125
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    • 2017
  • Objectives : The aim of this study was to assess the effectiveness of acupuncture in treating prehypertension and stage 1 hypertension in postmenopausal women. Methods : The study was a multi-center, four-arm, non-blinded, randomized clinical trial. Sixty participants were randomly assigned to experimental or control groups. The experimental groups received 10 acupuncture sessions over 4 weeks(Group A, n=20) or 20 sessions over 8 weeks(Group B, n=20) along with usual care. The acupoints were GB20, LI11, ST36, and SP6, bilaterally. The acupuncture groups were followed-up for an additional 12 weeks after acupuncture treatment. The control groups received usual care for 16 weeks(Group C, n=10) or 20 weeks(Group D, n=10). The outcomes were blood pressure, blood pressure control rates, lipid profile, and high-sensitivity C-reactive protein(hs-CRP). Results : After 4 weeks, DBP in the acupuncture groups(A+B) showed no significant decrease compared to the control group(C+D). However, after 8 weeks of acupuncture treatment, group B showed a significant decrease in DBP after acupuncture treatment and follow-up period compared to control group. Although there was no difference between the acupuncture and control groups in SBP after acupuncture treatment, group B showed a significant decrease in SBP compared to control group after follow-up period. Lipid profiles and hs-CRP did not differ significantly between acupuncture and control groups. Conclusions : Acupuncture treatment for 8 weeks showed the effect on prehypertension and mild hypertension. To verify the effect of acupuncture on blood pressure, rigorous trials including more participants are required.

The Research Trends on the Acupuncture Treatment of Lumbar Herniated Intervertebral Disc Using PubMed Database (PubMed 검색을 통한 요추 추간판 탈출증의 침치료 연구 동향)

  • Shin, Woo-Suk;Park, Won-Hyung;Cha, Yun-Yeop
    • Journal of Korean Medicine Rehabilitation
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    • v.24 no.4
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    • pp.49-60
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    • 2014
  • Objectives The purpose of this study is to research current trends of acupuncture treatment of lumbar herniated intervertebral disc using the PubMed database. Methods We set up the search strategy and investigated clinical trials on acupuncture treatment of lumbar herniated intervertebral disc through PubMed search. This study analyzed previous researched papers published from January 1st, 2000 to April 30th, 2014, and classified them by publication year, journal names, types of literature, treatment methods and evaluation scales. To assess the quality of the reviewed literature, randomized controlled trial (RCT) studies were assessed by Cochrane's risk of bias (ROB) tool and non-RCT studies were assessed by risk of bias for non-randomized studies (RoBANS). Results We found 35 studies on the acupuncture treatment of lumbar herniated intervertebral disc. Papers on this topic have been published, on average, three to four times annually in 9 journals since the mid-2000's. The journal with the largest number of publications was Chinese Acupuncture & Moxibustion, and most of articles were classified as RCT. Acupuncture treatment was performed individually or together with other treatments. The most frequently used pain evaluation index was visual analogue scale (VAS). The index of effective rate was used frequently but there was a lack of objectivity. In regards to the quality of the studies, outcome assessment in RCT showed that random sequence generation, allocation concealment, and the blinding of participants and personnel increase potential of risk of bias. For non-RCT assessment, outcome showed that confounding variable, measurement of intervention were at high risk of bias. Conclusions In order to obtain objective clinical evidence of acupuncture treatment of lumbar herniated intervertebral disc, further clinical studies should be designed to minimize the risk of bias, using STRICTA with larger sample sizes.

The Effects of Electroacupuncture for Treatment of Patients with Non-Alcoholic Fatty Liver Disease: Prospective Randomized Controlled Study (알코올성 지방간 환자에 있어 전침 치료의 효과: 무작위 배정 대조군 연구)

  • Lee, Chang-Hyeong;Kim, Byung-Seok;Choi, Ae-Ryun;Kim, Kyung-Soon;Kwak, Min-A;Kim, Seung-Mo
    • Journal of Korean Medicine for Obesity Research
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    • v.15 no.1
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    • pp.1-8
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    • 2015
  • Objectives: The aim of this study was to evaluate the effectiveness and safety of electroacupuncture for non-alcoholic fatty liver disease (NAFLD). Methods: A randomized, controlled pilot trial was conducted. Twenty-two participants were randomized into one of the two groups: an acupuncture group (n=11) and wait-list group (n=11). The treatment group received 8 sessions of electroacupuncture over 8 weeks. Twenty points (CV4, CV12, both LR14, GB26, ST25, ST34, ST40, ST36, SP4, SP6, LR3) were selected for needling. The control group did not receive acupuncture treatment during study period and followup were done in the 4th and 8th weeks after randomization in both groups. The primary outcome was body fat computed tomography and the secondary outcomes included blood test (aspartate aminotransferase, alanine transferase, triglyceride, total cholesterol, high density lipoproteincholesterol, low density lipoprotein-cholesterol, blood sugar test, ${\gamma}$-guanosine triphosphate) and body composition test (body mass index, weight, body fat mass, body fat rate, waist hip ratio). Safety was assessed at every visit. Results: There was no significant differences in between the experimental group and control group. There were no adverse events. Conclusions: The results suggest that In patients with NAFLD, electroacupuncture treatment did not induce worsening of liver disease and liver function, but it was no improvement symptoms of fatty liver. Study of herb medicine treatments and other acupuncture therapy of NAFLD are required later.

Effect of Beta Glucan on White Blood Cell Counts and Serum Levels of IL-4 and IL-12 in Women with Breast Cancer Undergoing Chemotherapy: A Randomized Double-Blind Placebo-Controlled Clinical Trial

  • Ostadrahimi, Alireza;Ziaei, Jamal Eivazi;Esfahani, Ali;Jafarabadi, Mohammad Asghari;Movassaghpourakbari, Aliakbar;Farrin, Nazila
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5733-5739
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    • 2014
  • Background: Breast cancer is the most common female malignancy in the world. Beta glucan can be a hematopoietic and an immune modulator agent in cancer patients. The aim of this trial was to determine the effect of beta glucan on white blood cell counts and serum levels of IL-4 and IL-12 in women with breast cancer undergoing chemotherapy. Materials and Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 30 women with breast carcinoma aged 28-65 years. The eligible participants were randomly assigned to intervention (n=15) or placebo (n=15) groups using a block randomization procedure with matching based on age, course of chemotherapy and menopause status. Patients in the intervention group received two 10-mg capsules of soluble 1-3, 1-6, D-beta glucan daily and the control group receiving placebo during 21 days, the interval between two courses of chemotherapy. White blood cells, neuthrophil, lymphocyte and monocyte counts as well as serum levels of IL-4 and IL-12 were measured at baseline and at the end of the study as primary outcomes of the study. Results: In both groups white blood cell counts decreased after 21 days of the intervention, however in the beta glucan group, WBC was less decreased non significantly than the placebo group. At the end of the study, the change in the serum level of IL-4 in the beta glucan group in comparison with the placebo group was statistically significant (p=0.001). The serum level of IL-12 in the beta glucan group statistically increased (p=0.03) and comparison between two groups at the end of the study was significant after adjusting for baseline values and covariates (p=0.007). Conclusions: The findings suggest that beta glucan can be useful as a complementary or adjuvant therapy and immunomodulary agent in breast cancer patients in combination with cancer therapies, but further studies are needed for confirmation.