Effect of Low-Pressure Drainage Suction on Pharyngocutaneous Fistula After Total Laryngectomy

2020 ◽  
Vol 130 (1) ◽  
pp. 32-37
Author(s):  
Mojtaba Maleki Delarestaghi ◽  
Aslan Ahmadi ◽  
Fatemeh Dehghani Firouzabadi ◽  
Maryam Roomiani ◽  
Mohammad Dehghani Firouzabadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Total Laryngectomy ◽  
Recovery Time ◽  
Low Pressure ◽  
Control Group ◽  
Pharyngocutaneous Fistula ◽  
Significant Difference ◽  
Drain Group ◽  
And Control

Objective: Pharyngocutaneous fistula (PCF) is one of the most severe multifactorial complications following laryngectomy. The current study aimed at determining the effect of a low-pressure vacuum drain on the incidence of PCF after total laryngectomy. Methods: The current randomized clinical trial was conducted on 35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran. The subjects were divided into the vacuum drain (n = 15) and control (without vacuum drain) (n = 20) groups. The incidence of PCF and the recovery time were recorded. Results: The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P < .05). There was no significant difference between the groups in time to recovery from PCF. Conclusion: The low-pressure vacuum drain method is effective in reducing the incidence of PCF after total laryngectomy.

scholarly journals Effect of lavender aromatherapy on well-being among hemodialysis patients: A randomized clinical trial

2018 ◽  
Author(s):  
Masoumeh Bagheri Nesami ◽  
Seyed Afshin Shorofi ◽  
Attieh Nikkhah ◽  
Hossein Roohi Moghaddam ◽  
Ali Mahdavi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Well Being ◽  
Underlying Disease ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Significant Difference ◽  
The Mean ◽  
And Control ◽  
Experimental Group

  In spite of the improvement of dialysis techniques, hemodialysis patients still experience debilitation. Impaired functioning, well-being, and quality of life are among the factors that are of a great concern in these patients. The current study aimed to examine the effects of lavender essential oil on well-being among hemodialysis patients. This randomized clinical trial was conducted on 30 hemodialysis patients. For each patient in the experimental group, five cotton balls were prepared using two drops of lavender essence diluted with sweet almond oil. Lavender was used at five concentrations of 10%, 20%, 30%, 40%, and 50%, administered through pinning the soaked cotton ball on the patients' collar on the first, second, third, fourth, and fifth weeks of the intervention, respectively. The patients were asked to breathe normally for 20 min. On the other hand, the control group received only routine nursing care. The perceived sense of well-being was measured in both groups at the end of each week using a visual analog scale. The mean ages of patients were obtained as 58.9 ± 14.31 and 53.03 ± 15.84 years for the experimental and control groups, respectively. Hypertension was reported to be the most common underlying disease in both groups. The results showed a significant difference in the mean level of well-being in the experimental group in the fourth and fifth weeks of the intervention, compared to that before the intervention. Inhalation aromatherapy with 40% and 50% lavender essence had a positive effect on the perceived sense of well-being in hemodialysis patients. However, lower concentrations of 10%, 20%, and 30% did not exert a comparable effect.

scholarly journals Effectiveness of Acupressure on the Taichong Acupoint in Lowering Blood Pressure in Patients with Hypertension: A Randomized Clinical Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Gan-Hon Lin ◽  
Wei-Chun Chang ◽  
Kuan-Ju Chen ◽  
Chen-Chen Tsai ◽  
Sung-Yuan Hu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Care Plan ◽  
Control Group ◽  
Optimal Dosage ◽  
Hypertensive Patients ◽  
Significant Difference ◽  
And Control ◽  
Experimental Group

Objectives. To evaluate the effectiveness of acupressure on the Taichong acupoint in lowering systolic and diastolic blood pressure (BP) in hypertensive patients.Methods. Eighty patients with hypertension attending a cardiology outpatient department in central Taiwan were included in this randomized clinical trial. Acupressure was applied to the Taichong acupoint in the experimental group (n=40) and to the first metatarsal (sham acupoint) in the control group (n=40). Blood pressure was measured by electronic monitoring before and immediately 15 min and 30 min after acupressure.Results. The average age of the experimental and control participants was 59.3 ± 9.2 years and 62.7 ± 8.4 years, respectively. The two groups were similar for demographics and antihypertensive drug use. Mean systolic and diastolic BP in the experimental group decreased at 0, 15, and 30 min after acupressure (165.0/96.3, 150.4/92.7, 145.7/90.8, and 142.9/88.6 mmHg); no significant changes occurred in the control group. There was a significant difference in systolic and diastolic BP between the experimental and control groups immediately and 15 and 30 min after acupressure (p<0.05).Conclusion. Acupressure on the Taichong acupoint can lower BP in hypertensive patients and may be included in the nursing care plan for hypertension. However, additional studies are needed to determine the optimal dosage, frequency, and long-term effects of this therapy.

scholarly journals The herbal combination of Sugarcane, Black Myrobalan, and mastic as a supplementary treatment for COVID-19: a randomized clinical trial

2021 ◽  
Author(s):  
Alireza Hashemi Shiri ◽  
Esmaeil Raiatdoost ◽  
Hamid Afkhami ◽  
Ruhollah Ravanshad ◽  
Seyed Ehsan Hosseini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Treatment Protocol ◽  
Vital Signs ◽  
Control Group ◽  
Event Analysis ◽  
Herbal Supplement ◽  
Significant Difference ◽  
And Control

AbstractBackgroundGiven the COVID-19 pandemic’s, researchers are beseeched for effective treatments. Herbal medicine is also queried for potential supplementary treatments for COVID-19. We aimed to evaluate the effects of Sugarcane, Black Myrobalan, and Mastic herbal medications for COVID-19 patients.MethodsThis was a double-blinded randomized clinical trial study conducted over three months from May to July 2020 in patients admitted with a diagnosis of COVID-19 in Peymaniyeh Hospital in Jahrom, Iran. The intervention group received the treatment protocol approved by the Ministry of Health of Iran during the period of hospitalization and the herbal supplement obtained from the combination of black myrobalan and mastic and sugarcane, twice a day (3g of herbal supplements). All patients were compared in terms of demographic variables, vital signs, clinical and laboratory variables.Results72 patients with COVID-19, divided into intervention (n=37) and control (n=35) groups. intervention and control groups had not any significant difference in terms of baseline characteristics. The time-to-event analysis revealed a significant difference in 4 symptoms of cough, fever, dyspnea, and myalgia (P<0.05). The Control group had a significantly lower decrease in C-reactive protein during 7 days (P<0.05). Patients in the herbal supplement group were hospitalized for 4.12 days and in the control group were hospitalized for 8.37 days (P=0.001). ICU admission and death only happened in 3 (8.6%) patients of the control group.ConclusionWhile advanced studies with more sample size are needed; the proposed combination seems to be effective in the symptom treatment and reducing the length of hospitalization.

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

scholarly journals The effect of autologous leukocyte platelet rich fibrin on the rate of orthodontic tooth movement: A prospective randomized clinical trial

2018 ◽  
Vol 12 (03) ◽  
pp. 350-357 ◽  
Author(s):  
Azita Tehranchi ◽  
Hossein Behnia ◽  
Fereydoun Pourdanesh ◽  
Parsa Behnia ◽  
Nelson Pinto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tooth Movement ◽  
Random Effect ◽  
Random Effect Model ◽  
Orthodontic Tooth Movement ◽  
Control Group ◽  
Extraction Socket ◽  
Effect Model ◽  
Significant Difference ◽  
And Control

ABSTRACT Objective: The aim of this study was to evaluate the effect of LPRF, placed in extraction sockets, on orthodontic tooth movement (OTM). Materials and Methods: Thirty extraction sockets from eight patients (five males, three females, with a mean age of 17.37 years; range 12–25 years) requiring extraction of first premolars based on their orthodontic treatment plan participated in this split-mouth clinical trial. In one randomly selected quadrant of each jaw, the extraction socket was preserved as the experimental group by immediate placement of LPRF in the extraction socket. The other quadrant served as the control group for secondary healing. Immediately, the teeth adjacent to the defects were pulled together by a NiTi closed-coil spring with constant force. A piece of 0.016 × 0.022-inch stainless steel wire was used as the main arch wire. The amount of OTM was measured on the study casts at eight time points with 2-week intervals for 3 months. Analysis of random effect model was performed for the purpose of comparison between the experimental and control groups. Results: According to the random effect model, a statistically significant difference was found between the experimental and control group in rate of OTM (P = 0.006). Conclusion: According to the results, application of LPRF, as an interdisciplinary approach combining orthodontics and surgery, may accelerate OTM, particularly in extraction cases.

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

Compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section: A double-blinded randomized clinical trial

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasijahromi ◽  
Hamed Hojati ◽  
Saeid Nikooei ◽  
Hossein Kargar Jahromi ◽  
Hamid Reza Dowlatkhah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Essential Oils ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Content Type ◽  
Gate Control Theory ◽  
Significant Difference ◽  
The Mean ◽  
Damask Rose

AbstractBackgroundAnxiety is the most common psychological reaction in women during labor. Similar to numerous other surgeries, postoperative pain is also reported following cesarean section (C-section). According to the (Gate) Control Theory, there is a relationship between pain and psychological problems such as anxiety. Accordingly, the present study aimed to compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section.MethodsThis triple-group randomized clinical trial was performed on 90 mothers who visited Motahari Hospital of Jahrom, Iran, for C-section in 2017. The incidence and severity of pain and anxiety were measured and recorded for all three groups prior to intervention. The intervention groups underwent aromatherapy with lavender and Damask rose essential oils. Patients were asked to inhale cotton balls, separately stained with three drops of each essential oil at a distance of 10 cm for 30 mins. The severity of pain and anxiety was measured using the visual analogue scale (VAS) and the Spielberger State-Trait Anxiety Inventory (STAI) 5 min after the specified process, respectively. The control group underwent aromatherapy in a similar fashion with normal saline. Finally, data were analyzed using descriptive statistical indices and ANOVA and Kruskal–Wallis tests in SPSS 21.ResultsThere was no significant difference between the three groups in the mean severity of pain and anxiety before the intervention (p>0.05). The mean severity of pain and overt anxiety in the lavender and Damask rose aromatherapy groups was significantly different than the control group after the intervention (p<0.001). In addition, no significant difference was observed between the overt and overall anxiety levels of the two intervention groups after the intervention (p>0.05).ConclusionsThe findings suggested that inhalation aromatherapy can reduce the severity of overt anxiety and pain after C-section, with Damask rose essential oil showing a larger effect than lavender.

scholarly journals Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial

2017 ◽  
Vol 70 (6) ◽  
pp. 1244-1249 ◽  
Author(s):  
Sabrina Gisele Tobias da Silva ◽  
Maiara Aurichio Santos ◽  
Claudia Maria de Freitas Floriano ◽  
Elaine Buchhorn Cintra Damião ◽  
Fernanda Vieira de Campos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Statistical Significance ◽  
School Age Children ◽  
Control Group ◽  
School Age ◽  
Chi Square ◽  
Number Of Children ◽  
Significant Difference ◽  
Therapeutic Play ◽  
And Control

ABSTRACT Objective: To evaluate the effects of Dramatic Therapeutic Play (DTP) technique on the degree of anxiety in hospitalized school-age children. Method: Randomized clinical trial performed in two hospitals ofSão Paulo, between May and October 2015. The intervention consisted of the application of DTP and the outcome was evaluated through the Child Drawing: Hospital (CD: H) instrument. The Wilcoxon-Mann Whitney, Corrected t, Fisher’s exact and Chi-square tests were used in the analysis. Statistical significance was set at 5%. Results: In all, 28 children participated in the study. The majority of children (75%) had a low anxiety score, with a mean CD: H score of 73.9 and 69.4 in the intervention and control groups respectively, and with no significant difference. Conclusion: Children submitted to DTP had the same degree of anxiety as those in the control group. However, it is suggested that new studies be performed with a larger number of children in different hospitalization scenarios.

scholarly journals Evaluating the Effects of Spraying Oxytetracycline on Diabetic Foot Ulcers: A Randomized Clinical Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Gholam Hosein Kazemzadeh ◽  
Hasan Ravari ◽  
Masomeh Nabavizadeh ◽  
Saeid Pasban Noghabi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Purulent Discharge ◽  
Foot Ulcers ◽  
Diabetic Patients ◽  
Diabetic Foot Ulcers ◽  
Significant Difference ◽  
And Control

Background: Diabetic foot ulcers (DFUs) can be created due to neuropathy and peripheral vascular disease in the lower limbs. Objectives: This study aimed to evaluate the effects of spraying oxytetracycline on DFU. Methods: This randomized clinical trial was conducted on 60 diabetic patients suffering from DFU. The patients were randomly assigned into two equal groups of intervention and control (n = 30 each). While all subjects received antibiotic therapy, blood sugar control, and, if necessary debridement, the intervention group received oxytetracycline spraying on the DFUs twice a day. After the intervention, the patients were visited every week (for three weeks), photos were taken of the DFUs by special software, and the size of the DFUs was checked. The DFUs were also studied in terms of purulent discharge, the smell, and erythema, and edema around the ulcer. After three weeks, the healing of ulcers were compared in the two groups. Data were gathered and analyzed using the SPSS software version 11.5, descriptive statistical test, chi-square, and t-test. Results: Before the study, the size of the DFUs in the intervention and control groups was 110.87 ± 38.3 and 127.12 ± 40 mm2, respectively. After the treatment, the alterations in the intervention group in the first, second, and third weeks were 14.90 ± 14.41, 26.93 ± 18.86, and 41.25 ± 19.51, respectively. Also, in the control group, the alterations were 19.45 ± 1.35, 23.78 ± 5.31, and 13.29 ± 8.75, respectively. There was a statistically significant difference in the size of DFUs between the two groups (P < 0.05). Conclusions: According to the results, spraying oxytetracycline on DFUs facilitated the process of healing. Thus, it can be used as an affordable, available, and effective method.

scholarly journals The effect of delivery ball and warm shower on the childbirth experience of nulliparous women: A randomized controlled clinical trial

2021 ◽  
Author(s):  
parvaneh sharifipour ◽  
Masoomeh Kheirkhah ◽  
Mojgan Rajati ◽  
hamid haghani
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Childbirth Experience ◽  
Nulliparous Women ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Abstract Background Childbirth is a unique experience that affects women’s life. Therefore, this study was performed to determine the effect of delivery ball and warm shower on the childbirth experience of primiparous women. Methods This study is a clinical trial that was carried out on primiparous pregnant women referred to Motazedi Hospital in Kermanshah, Iran. Sampling was done by continuous method and pregnant women were divided into three groups of delivery ball-warm shower (n = 33), delivery ball (n = 33) and control (n = 33). Exercise with ball at the dilation of 4 cm was similar in the two groups of delivery ball-warm shower and delivery ball, but the first group also used warm shower at the dilatation of 7 cm. The control group only received the routine delivery care. Demographic information form consisting of pregnancy history and information about the mother and infant were completed and the childbirth experience questionnaire (CEQ) were completed by the women two hours after the childbirth. Results There was a statistically significant difference in the mean score of childbirth experience after the intervention between the two groups of delivery ball-warm shower and control (P = 0.001), and also between the delivery ball and control groups (P = 0.001). There was a statistically significant difference in the mean scores of professional support between the two groups of delivery ball-warm shower and control (P = 0.02) and also between the delivery ball and control groups (p = 0.02). There was a statistically significant difference in the mean scores of participation between the two groups of delivery ball-warm shower and control (P = 0.003) and also between the delivery ball and control groups (P = 0.01). There was also a statistically significant difference in the mean scores of sense of security between the two groups of delivery ball-warm shower and control (P = 0.01). Conclusion Delivery ball and warm shower were effective interventions to create a positive childbirth experience. This method was more effective than using delivery ball alone in childbirth experience. To achieve a positive experience of childbirth in mothers, the use of both intervention (delivery ball and warm shower) is recommended.

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