• Title/Summary/Keyword: randomized clinical controlled trial

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Comparative evaluation of the effectiveness of two innovative methods in the management of anxiety in a dental office: a randomized controlled trial

  • Panchal, Jay;Panda, Anup;Trivedi, Krishna;Chari, Deepika;Shah, Rushita;Parmar, Binny
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.4
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    • pp.295-304
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    • 2022
  • Background: The first dental experience is vital in molding a child's attitude towards dentistry and dental outcomes. The cooperation of a child during dental treatment is essential to render successful and high-quality treatment. Dental anxiety is common in children undergoing dental treatment. The success of pediatric dental treatments and patient comfort depends on controlling the levels of patient anxiety in clinical settings. This study aimed to compare the effectiveness of the recorded maternal voice and virtual cognitive tool (Roogies application) in the management of pediatric dental patients. Methods: The study was carried out with children aged of 4-7 years [n = 80, (40 male and 40 female)], without any past dental history, and were randomly allocated into two groups. After informed consent was obtained, the entire procedure was explained to the parents. Anxiety was assessed pre-, during, and post-treatment by measuring pulse rate, and recording Venham Picture Test (VPT) scores. Group A [n = 40; 20 boys and 20 girls)] was provided with a headphone that played a recorded maternal voice. Group B [n = 40; 20 boys and 20 girls)] was administered the virtual cognitive tool. After conditioning the children, oral prophylaxis was performed for both groups. A comparative evaluation was conducted for each treatment session. Results: The intra-group comparison of VPT scores and heart rate for patients assigned to the recorded maternal voice showed a statistically significant difference in dental anxiety (P-value ≤0.001). Conclusion: This study demonstrated that a reduction in dental anxiety with the help of recorded maternal voice forms an important component of non-pharmacological behavior management. Alternatively, the use of a virtual cognitive tool as an anxiety-reducing technique can also be advocated.

The efficacy of low-level diode laser versus laser acupuncture for the treatment of myofascial pain dysfunction syndrome (MPDS)

  • Khalighi, Hamid Reza;Mortazavi, Hamed;Mojahedi, Seyed Masoud;Azari-Marhabi, Saranaz;Parvaie, Parvin;Anbari, Fahimeh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.1
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    • pp.19-27
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    • 2022
  • Background: Myofascial pain dysfunction syndrome (MPDS) is the most common type of temporomandibular disorder. This study compared the efficacies of low-level diode laser therapy (LLLT) and laser acupuncture therapy (LAT) in the treatment of MPDS. Methods: This double-blind randomized controlled clinical trial included 24 patients with MPDS who were randomly divided into two equally sized groups. Patients in the LLLT group received 12 sessions of low-level diode laser irradiation applied to the trigger points of the masticatory muscles during 1 month. The same protocol was also used in the LAT group according to the specific trigger points. We measured pain intensity and maximum mouth opening in both groups at baseline, during treatment, and 2 months after treatment completion. Results: The pain intensities decreased from 6.58±1.31 to 0.33±0.65 and from 7.08 ± 1.37 to 0 in the LLLT and LAT groups, respectively. The maximum mouth openings increased from 32.25 ± 8.78 mm to 42.58 ± 4.75 mm and from 33 ± 6.57 mm to 45.67 ± 3.86 mm in the LLLT and LAT groups, respectively. Pain intensity (P = 0.839) and level of maximum mouth opening (P = 0.790) did not differ significantly between the groups. Conclusion: Our results showed similar efficacy between LLLT and LAT in the treatment of MPDS signs and symptoms.

Effects of the Insulin Therapy Adherence Program for Patients with Type 2 Diabetes: A Randomized Controlled Trial (제2형 당뇨병 환자를 위한 인슐린치료이행증진 프로그램의 효과: 무작위대조군실험설계)

  • Park, Kyung Min;Son, Jung Tae
    • Journal of Korean Clinical Nursing Research
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    • v.28 no.3
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    • pp.277-288
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    • 2022
  • Purpose: This study was conducted to evaluate the effects of the insulin therapy adherence program (INSTA GRAM) for patients with type 2 diabetes mellitus. Methods: This study examined a total of 63 patients with type 2 diabetes for whom the initiation of insulin therapy is being considered or within 6 months of undergoing insulin therapy. INSTAGRAM is a stage-specific intervention consisting of strategies for motivating patients to initiate and maintain insulin therapy using the transtheoretical model on the stages of change, the process of change, and self-efficacy. The participants were randomly assigned to either the INSTAGRAM group (experimental group, n=32) or the standard diabetes education group (control group, n=31). The INSTAGRAM group received 6 sessions over 8 weeks(face-to-face education was conducted in the first and last sessions, and telephone coaching was conducted from the second to fifth sessions). The outcomes were measured by psychological insulin resistance, self-efficacy, and glycosylated hemoglobin (HbA1c). Results: Psychological insulin resistance (p<.001), self-efficacy (p<.001), and HbA1c (p=.024) of the participants in the INSTAGRAM group significantly improved compared to those in the control group. Conclusion: INSTAGRAM is effective in overcoming psychological insulin resistance and improving self-efficacy and HbA1c. Therefore, the INSTAGRAM can be recommended as a nursing intervention for type 2 diabetic patients who delay the initiation of insulin therapy.

Restoration of the Broken Lumbopelvic-hip Neuromuscular Chain and Coordinated Synergistic Activation in Low Back Pain

  • Park, Haeun;Park, Chanhee;You, Joshua (Sung) Hyun
    • Physical Therapy Korea
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    • v.29 no.3
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    • pp.215-224
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    • 2022
  • Background: The presence of the lumbopelvic-hip neuromuscular chain is essential for dynamic spinal stabilization; its therapeutic effects on dynamic movements of the distal extremity segment and underpinning motor mechanism remain unknown and warrant further study on participants with low back pain (LBP). Objects: We aim to compare the effects of the broken chain exercise (BCE) and connected chain exercise (CCE) on electromyography (EMG) amplitude and onset time in participants with and without LBP. Methods: Randomized controlled clinical trial. A convenience sample of 40 nonathletic participants (mean age: 24.78 ± 1.70) with and without LBP participated in this study. All participants underwent CCE for 30 minutes, 30-minute daily. We measured EMG amplitude and onset times on bilateral erector spinae (ES), gluteus maximus (GM), hamstring (HAM), transverse abdominis (TrA), internal oblique (IO), and external oblique (EO) during the prone hip extension (PHE) test before and after the BCE and CCE. We used multivariate analysis of variance (MANOVA) to analyze the amplitude and onset time difference between exercises (BCE and CCE) and Pearson's correlations to determine any synergistic relationship among the HAM, GM, bilateral TrA/IO, and ES muscles. The statistical analyses were used at p < 0.05. Results: MANOVA showed that CCE was more decreased on EMG amplitude in HAM and bilateral ES, while increased GM and contralateral TrA/IO than BCE (p < 0.05). MANOVA EMG onset time data analyses revealed that the main effect of the conditions was significant for all HAM, GM, and bilateral ES muscles, whereas the main effect for the group was significant only for GM and contralateral ES in healthy and LBP groups. Pearson's correlation coefficient was computed to assess the relationship between BCE and CCE on dependent variables. In most of the muscles, there was a strong, positive correlation between the two variables, and there was a significant relationship (p < 0.001). Conclusion: CCE produced more effective and coordinated core stabilization and motor control mechanism in the lumbopelvic-hip muscles in participants with and without LBP during PHE than BCE.

Effects of Bone Marrow Aspirate Concentrate-Platelet-rich Plasma Versus Hyaluronic Acid on Patients with Knee Osteoarthritis: A Randomized Controlled Trial (골수 흡인-혈소판 풍부 혈장과 히알루론산의 관절강내 주사의 효과 비교)

  • Lee, Byung Chan;Kim, Ah Ran;Kim, Eun Kyung;Kim, Sun Jeong;Kim, Sang Jun
    • Clinical Pain
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    • v.19 no.1
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    • pp.8-15
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    • 2020
  • Objective: To compare the therapeutic efficacy of the bone marrow aspirate concentrate (BMAC)- platelet-rich plasma (PRP) complex with hyaluronic acid in patients with knee osteoarthritis. Method: Thirty-four patients with knee osteoarthritis participated in this study. Seventeen patients in the study group underwent BMAC and PRP extraction followed by intra-articular injection of BMAC-PRP complex within affected knee. Seventeen patients in the control group underwent intra-articular injection of hyaluronic acid. Knee injury, osteoarthritic outcome score (KOOS), and EuroQol-5D (EQ-5D) questionnaire were evaluated before, one month, three months, and six months after the injection. Results: There were statistically significant temporal differences in total KOOS scores in both BMAC-PRP and HA groups. However, there were no significant group difference in the study period. In the Sports and Recreational Function Scale, there was statistically significant improvement in the BMAC-PRP group compared to the HA group at three months (p=0.041). There were no side effects or complications in both groups. Conclusion: Intra-articular injection of BMAC-PRP showed better functional recovery in the OA at three months and this can be an alternative treatment in terms of functional recovery in the OA in addition to the decrease of pain.

Efficacy of Portable Low Power Laser Therapy on Pain and Functions in Chronic Low Back Pain (만성 요통 환자에서의 휴대용 저출력 레이저 치료기의 통증 및 기능 효과)

  • Cho, Yeon Wook;Kim, Tae Hee;Lim, Oh Kyung;Lee, Ju Kang;Park, Ki Deok
    • Clinical Pain
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    • v.19 no.1
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    • pp.1-7
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    • 2020
  • Objective: A prospective, assessor-blinded, randomized controlled trial was conducted in patients with chronic low back pain to evaluate the efficacy of portable low power laser therapy (LPLT) and the effect when combined with exercise therapy on pain and functions. Method: 60 patients were recruited and 56 patients, excluding 4 dropouts, were randomly allocated to the LPLT group (Group 1: 19 patients), placebo laser therapy with exercise group (Group 2: 18 patients), and LPLT with exercise group (Group 3: 19 patients). Laser therapy and exercise was performed five times a week for 4 weeks. Visual analogue scale (VAS), Schober test, lumbar range of motion (ROM) measures (flexion, extension and lateral flexion), Oswestry Disability index (ODI) were measured at baseline, at 4 weeks after intervention, and at 6 weeks after 2 weeks of no intervention. Results: Statistically significant improvements were noted in all group by time interaction with respect to all outcome parameters (p<0.05). All parameters in each group improved not only in the period of treatment (4 weeks), but also in the final evaluation (6 weeks) 2 weeks after the end of treatment. Post-hoc analysis showed statistically significant difference between the LPLT with exercise group and the other groups in all outcome parameters except for the ODI at 4 weeks and at 6 weeks. Conclusion: Portable LPLT is effective treatment in reducing pain and improving lumbar ROM and with exercise is more effective than laser or exercise monotherapy for the chronic low back pain patients.

Effect of push-up plus exercise on shoulder stabilization muscle thickness in healthy adults in their twenties on various support surfaces (다양한 지지면에서 푸쉬업 플러스 운동이 20대 건강한 성인의 어깨 안정화 근육 두께에 미치는 영향)

  • Jeong, Jin Gyu;Park, Jae Cheol
    • Journal of Korean Physical Therapy Science
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    • v.29 no.3
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    • pp.48-55
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    • 2022
  • Background: The purpose of this study is to examine the effect of push-up plus exercise on the changes in the thickness of the trapezius trapezius, serratus anterior and pectoralis major muscles involved in shoulder stability in various support surfaces. Design: Randomized controlled trial. Methods: The thickness change of the shoulder stabilizing muscle was measured using an ultrasound device. Corresponding t-test was performed to confirm the change within the group before the experiment and after 5 weeks. And one-way ANOVA was used to confirm the change between groups after 5 weeks. As a post hoc test, the least significant difference test was performed, and the significance level was set to a=0.05. Results: Changes in the thickness of the trapezius muscle within the group were significantly different between UPEG and SPEG after 5 weeks (p<0.05), and there was a significant difference between groups after 5 weeks (p<0.05). Changes in the thickness of the serratus anterior and pectoralis major muscle within the group were significantly different after 5 weeks in PEG, UPEG and SPEG (p<0.05), and the changes between the groups were significantly different in the serratus anterior muscle after 5 weeks (p<0.05). Conclusion: From the results of this study, it was found that the push-up exercise on an unstable support surface was effective for strengthening the trapezius upper and serratus anterior. This study intends to suggest the possibility of application as basic data for a push-up plus exercise program in clinical practice.

Effects of Upper Trapezius Inhibition Dynamic Taping on Pain, Function, Range of Motion, Psychosocial Status, and Posture of the Neck in Patients With Chronic Neck Pain (위등세모근 억제 다이나믹 테이핑이 만성 목 통증 환자들의 목 통증, 기능장애 수준, 관절가동범위, 심리사회적 수준, 목 자세정렬에 미치는 영향)

  • Yoon, Sang-woo;Kim, Suhn-yeop
    • Physical Therapy Korea
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    • v.29 no.1
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    • pp.1-10
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    • 2022
  • Background: Neck pain is a major health problem in developed countries and has a lifetime prevalence of 50%. Major problems include a reduced cervical range of motion, muscle stiffness, dysfunction, postural changes, and decrease in psychosocial level. Objects: This study aimed to investigate the effects of applying the upper trapezius inhibition dynamic taping to patients with chronic neck pain on their neck pain, functional level, cervical range of motion, psychosocial level, and neck posture. Methods: The study design was a randomized controlled trial. A total of 40 patients with neck pain participated in this study and were randomly assigned to a Dynamic Taping group (n = 20) or Sham Taping group (n = 20). In both groups, basic intervention cervical pain control therapy and shoulder stabilization exercise program were performed. In addition, dynamic taping and sham taping were applied to participants in the Dynamic Taping and Sham Taping groups to inhibit the trapezius muscle, respectively. All interventions were performed three times a week and a total of 12 times for 4 weeks, and the participants' neck pain, functional impairment level, cervical range of motion, psychosocial level, and neck posture were measured and compared before and after the intervention. Results: Both groups showed significant differences in neck pain, functional level, cervical range of motion, psychosocial level, and neck postural before and after the intervention (p < 0.05). Moreover, there were significant differences between the two groups regarding the functional level and neck posture (p < 0.05). Conclusion: Inhibition dynamic taping of the upper trapezius muscle suppression is an effective method with clinical significance in reducing pain in individuals with chronic neck pain and improving the functional level, cervical range of motion, psychosocial level, and neck posture.

Effect of Auricular Acupuncture on Nonsteroidal Antiinflammatory Drug Dose in Primary Dysmenorrhea : A Randomized Controlled Trials (비스테로이드성 소염진통제를 복용하는 원발성 월경곤란증 환자에 대한 이침치료의 무작위대조군임상시험)

  • Hur, Da-Hee;Kang, So-Hyeon;Kwon, Han-Seul;Ahn, Ha-Young;Baek, Hyung-Chan;Kim, Hyeong-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.35 no.4
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    • pp.161-173
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    • 2022
  • Objectives: This study was conducted to evaluate the effectiveness of acupuncture in patients with primary menstrual difficulties taking NSAIDs. Methods: 30 women with primary menstrual difficulties with NSAIDs were assigned to treatment groups (n=15) and control groups (n=15). On their first visit, both groups were provided with a menstrual diary and were required to record the intensity of pain and the dosage of painkillers during each menstrual cycle. The treatment group received two acupuncture treatments per cycle during two cycles, and the control group did not receive acupuncture. Pain strength during menstruation was evaluated using Visual Analogue Scale (VAS), and the total number of painkillers taken during menstruation and the average number of painkillers taken during a single dose was measured. Results: The treatment group had significant pain relief compared to the pre-test group and significant differences from the control group. In addition, there was a significant difference between the treatment group and the control group in the frequency of taking painkillers during the menstrual period and the dose in the test group was significantly lower than before treatment. Conclusions: This clinical trial showed that this acupuncture can help alleviate primary menstruation and reduce the use of nonsteroidal anti-inflammatory drugs.

Effects of a Modified Six-Sigma-Methodology-Based Training Program on Core Competencies in Rehabilitation Nurse Specialists

  • Gu, Jiayi;Luo, Lan;Li, Chengjuan;Ma, Sumin;Gong, Fanghua
    • Journal of Korean Academy of Nursing
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    • v.53 no.4
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    • pp.412-425
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    • 2023
  • Purpose: Nurses play an important role in ensuring patient rehabilitation and are involved in all aspects of multidimensional rehabilitation. Therefore, strengthening rehabilitation nursing education is vital to ascertain high-quality rehabilitation and optimum outcomes. This study examined the effectiveness of a new teaching reform-a modified Six-Sigma-based training program-against a conventional educational program on rehabilitation specialist nurses' core competencies, post-training performance, and satisfaction. Methods: A quasi-randomized controlled trial was conducted to assess the effectiveness of the modified training program. We recruited 56 learners from the 2020 training course at the Hunan Rehabilitation Specialist Nurse Training Base as the control group. Sixty learners from the base's 2021 training course were recruited as the intervention group. Data were collected in a consistent manner from both groups after the training program was implemented. Results: Those who underwent the modified training program showed better improvement in all core competencies than those who underwent the conventional training program (p < .05); the scores for theoretical knowledge, clinical nursing lectures, reviews, and nursing case management improved significantly following the teaching reform (p < 0.05). Further, overall satisfaction as well as base management and theoretical teaching satisfaction improved significantly (p < .05). Conclusion: The modified training program strengthens rehabilitation nurses' base management abilities; enhances their core competencies; expands their interest in and breadth, depth, and practicability of theoretical courses; and updates the teaching methods.