Impact on antimicrobial consumption of procalcitonin-guided antibiotic therapy for pneumonia/pneumonitis associated with aspiration in comatose mechanically ventilated patients: a multicenter, randomized controlled study

Abstract Background In comatose patients receiving oro-tracheal intubation for mechanical ventilation (MV), the risk of aspiration is increased. Aspiration can lead to chemical pneumonitis (inflammatory reaction to the gastric contents), or aspiration pneumonia (infection caused by inhalation of microorganisms). Distinguishing between the two types is challenging. We tested the interest of using a decisional algorithm based on procalcitonin (PCT) values to guide initiation and discontinuation of antibiotic therapies in intubated patients. Methods The PROPASPI (PROcalcitonin Pneumonia/pneumonitis Associated with ASPIration) trial is a multicenter, prospective, randomized, controlled, single-blind, superiority study comparing two strategies: (1) an intervention group where threshold PCT values were used to guide initiation and discontinuation of antibiotics (PCT group); and (2) a control group, where antibiotic therapy was managed at the physician’s discretion. Patients aged 18 years or over, intubated for coma (Glasgow score ≤ 8), with MV initiated within 48 h after admission, were eligible. The primary endpoint was the duration of antibiotic treatment during the first 15 days after admission to the ICU. Results From 24/2/2015 to 28/8/2019, 1712 patients were intubated for coma in the 5 participating centers, of whom 166 were included in the study. Data from 159 were available for intention-to-treat analysis: 81 in the PCT group, and 78 in the control group. Overall, 67 patients (43%) received antibiotics in the intensive care unit (ICU); there was no significant difference between groups (37 (46%) vs 30 (40%) for PCT vs control, p = 0.432). The mean duration of antibiotic treatment during the first 15 days in the ICU was 2.7 ± 3.8 days; there was no significant difference between groups (3.0 ± 4.1 days vs 2.3 ± 3.4 days for PCT vs control, p = 0.311). The mean number of days under MV was significantly higher in the PCT group (3.7 ± 3.6 days) than in controls (2.7 ± 2.5 days, p = 0.033). The duration of ICU stay was also significantly longer in the PCT group: 6.4 ± 6.5 days vs 4.6 ± 3.5 days in the control group (p = 0.043). After adjustment for SAPS II score, the difference in length of stay and duration of mechanical ventilation between groups was no longer significant. Conclusion The use of PCT values to guide therapy, in comparison to the use of clinical, biological (apart from PCT) and radiological criteria, does not modify exposure to antibiotics in patients intubated for coma. Trial registration Clinicaltrials.gov Identifier NCT02862314.

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The effectiveness of the robotic game kit on anxiety among hospitalized preschool children: A non-randomized controlled trial

Nursing Practice Today ◽

10.18502/npt.v8i4.6703 ◽

2021 ◽

Author(s):

Sima Pourteimour ◽

Sahar Kazemi

Keyword(s):

Separation Anxiety ◽

Controlled Trial ◽

Intervention Group ◽

Analysis Of Covariance ◽

Control Group ◽

Controlled Clinical Trial ◽

Psychological Burden ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean

Background & Aim: Hospitalization is a challenging experience all children go through in their lives, leading to their utmost anxiety. In this sense, interactive games and activities can help ease this psychological burden. Therefore, we endeavored to determine the effectiveness of a robotic game kit (RGK) on the anxiety of hospitalized preschoolers. Methods & Materials: This non-randomized controlled clinical trial was conducted in a pediatric hospital, Iran, between March and July 2019. 59 participants were assigned to intervention (n=30) or control (n=29) groups through available sampling. Inclusion criteria were Iranian native children aged 3-7 years with communication ability. The RGK was applied in eight sessions at least seven consecutive days of hospitalization. The collected data by using the demographic information form and the preschool anxiety scale (PAS) were analyzed in descriptive, chi-square, t-test, the one-way ANCOVA (analysis of covariance), and multivariate analysis of covariance (MANCOVA). Results: Two groups were homogenous in terms of demographic variables (p>0.05). There was no statistically significant difference between the mean score of PAS before the intervention in the intervention 46.33±15.81 and control groups 37.24±19.65 (p=0.055). However, the mean score of PAS in the intervention group was significantly lower than the control group (P=0.030). Also, using the RGK was effective in two subscales related to separation anxiety and physical injury fears (P=0.034). Conclusion: The modern RGKs could have a significant place in pediatric health care in hospitals. It is thus an undeniable fact that high-quality, comprehensive care can be boosted through RGK based interventions for children encountering stressful situations.

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The effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia: a parallel randomized controlled trial

BMC Psychology ◽

10.1186/s40359-021-00542-5 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Maryam Behrouian ◽

Tahereh Ramezani ◽

Mahlagha Dehghan ◽

Abdoreza Sabahi ◽

Batool Ebrahimnejad Zarandi

Keyword(s):

Randomized Controlled Trial ◽

Emotion Regulation ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Control Group ◽

Psychological Traits ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean

Abstract Background Schizophrenia is the most severe mental chronic disabling disease that the majority of the patients need constant care in a variety of aspects. Regarding the role of family caregivers in taking care of these patients, caregivers need to be resilient, in addition to other psychological traits, to adapt to the circumstance. This study aimed to investigate the effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia in southeastern Iran. Methods The study was a parallel randomized controlled trial. Seventy caregivers of patients with schizophrenia were selected by convenience sampling method and randomly assigned to an emotion regulation training group and a control group. The intervention group received eight 90-min training sessions (one session weekly) about emotion regulation. The participants completed the Conner–Davidson resilience scale before and one month after the intervention. Results The mean scores of the resilience increased in the control and intervention groups at the end of the study. A significant difference was found between the two groups (p < 0.001). At the beginning of the study, the mean score of the resilience was 59.94 in the control group and 51.97 in the intervention group. However, the mean score of the resilience in the control group was 61.28 after the intervention, which was not significant, but it was 69.08 in the intervention group, which was significant. A significant difference was observed between two groups in the mean scores (p = 0.01). Conclusions According to the results of this study, cognitive and metacognitive skills of emotion regulation can be suggested as one of the methods for increasing the psychological well-being of schizophrenia patients’ caregivers. The increase of mental well-being and resilience of caregivers can help them better manage a patient with schizophrenia. Trial registration IRCT registration number: IRCT2017061733997N2, Registration date: 2017-08-16, 1396/05/25, Registration timing: prospective, https://en.irct.ir/trial/26116

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The Effect of Distraction Techniques on Pain and Stress during Labor: A Randomized Controlled Clinical Trial

10.21203/rs.2.13303/v1 ◽

2019 ◽

Author(s):

Paria Amiri ◽

Mojgan Mirghafourvand ◽

Khalil Esmaeilpour ◽

Mahin Kamalifard ◽

Reyhaneh Ivanbagha

Keyword(s):

Intervention Group ◽

Active Phase ◽

Control Group ◽

Controlled Clinical Trial ◽

Fear Of Childbirth ◽

Control Groups ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean ◽

And Control

Abstract Background The aim of this study was to determine the effect of distraction techniques on labor pain and stress (primary outcomes), fear of childbirth, and length of delivery stages (secondary outcomes). Methods A randomized controlled clinical trial was conducted on 68 pregnant women. Participants were allocated into two intervention and control groups by blocked randomization. Participants in the intervention group received distraction techniques in four sessions. Questionnaires of Fear of Childbirth (W-DEQ version A) and PSS once were completed before intervention and again at the 36th week for the W-DEQ and in the active phase for the PSS through interviews. The pain was assessed through VAS during active phase per hour. The length of delivery stages was recorded in the partograph chart. Data were analyzed by independent t-test and ANCOVA. Results The mean of perceived stress during labor in the intervention group was significantly less than that of the control group (AMD: -3.2; 95% CI: -0.8 to -6.0; P= 0.01). The mean (SD) of pain intensity was 6.2 (1.4) and 7.5 (1.4) in the intervention and control groups, respectively, which indicated a significant difference between the two groups (P<0.001). Although the mean score of fear in 36th week in the intervention group (29.1) was less than of the control group (39.1), there was no significant difference between the two groups (P= 0.170). Moreover, there was no statistically significant difference between the two groups in terms of the length of the delivery stages (P>0.05). Conclusion According to the results, distraction techniques can reduce the pain and stress of labor, but further studies are needed to reach a decisive conclusion.

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06045-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Keivan Ranjbar ◽

Mohsen Moghadami ◽

Alireza Mirahmadizadeh ◽

Mohammad Javad Fallahi ◽

Vahid Khaloo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Status ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Ordinal Scale ◽

Control Group ◽

Randomized Controlled ◽

Group Data ◽

Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

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The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Asieh Mehdipour ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Maryam Dastoorpoor

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Moderate Depression ◽

Before And After ◽

The Mean ◽

And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

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Effects of Relationship Enrichment Training on Improving Marital Satisfaction of Infertile Couples: A Randomized Control Trial

Current Women s Health Reviews ◽

10.2174/1573404817666210111141202 ◽

2021 ◽

Vol 17 ◽

Author(s):

Seyedeh Zahra Masoumi ◽

Khodayar Oshvandi ◽

Masoumeh Rostami-Moez ◽

Arezoo Shayan ◽

Farideh Kazemi

Keyword(s):

Marital Satisfaction ◽

Intervention Group ◽

Analysis Of Covariance ◽

Control Group ◽

Chi Square ◽

Significance Level ◽

Significant Difference ◽

The Mean ◽

Infertile Couples ◽

Relationship Enrichment

Background: Infertility can cause low marital satisfaction. Marital satisfaction has an important effect on infertile couples’ health. Objective: This study aimed to assess the effect of relationship enrichment training on improving the marital satisfaction of infertile couples. Methods: This randomized clinical trial was conducted on 50 infertile couples in the infertility center of Fatemieh Hospital in Hamadan, Iran in 2018. Participants were matched for demographic characteristics and randomly assigned to intervention and control groups (each group had 25 couples). Informed consent was obtained from all participants. The Enrich Marital Satisfaction questionnaire and demographic information were used to collect data before the study and two months after the intervention. Two trained midwifery students taught only the intervention group the relationship enrichment topics in seven sessions (each session = 90 minutes). The data were analyzed by SPSS Statistics version 21 using analysis of covariance, independent t-test, chi-square, and Mann–Whitney. The significance level was set at p ≤ 0.05. Results: There was no significant difference in demographic and obstetric information between the two groups (p >0.05). The mean of marital satisfaction in the intervention group significantly increased among women and men from 151.00 ±28.61 to 154.88 ±22.62 and from 152.56 ±27.33 to 159.24 ±22.14, respectively, (p <0.001). Conversely, the mean of marital satisfaction decreased among women and men from 158.13 ±13.86 to 146.25 ±19.53 and from 164.25 ±17.00 to 153.17 ±27.50 in the control group (p=0.02). Conclusion: Relationship enrichment training can be effective in promoting the marital satisfaction of infertile couples. Registration number: The National Center for Strategic Research in medical education, No. 960185.

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Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors—A Pilot Randomized Controlled Study

Biological Research For Nursing ◽

10.1177/10998004211050297 ◽

2021 ◽

pp. 109980042110502

Author(s):

Zhan Liang ◽

Hilary Yip ◽

Kimberly Sena Moore ◽

Tanira Ferreira ◽

Ming Ji ◽

...

Keyword(s):

Muscle Strength ◽

Lower Extremity ◽

Active Control ◽

Exercise Intervention ◽

Controlled Study ◽

Control Group ◽

Active Control Group ◽

Randomized Controlled ◽

Left And Right ◽

The Mean

Objective The objective of this study was to evaluate effects of a self-managed music-guided exercise intervention on muscle strength among intensive care unit (ICU) survivors. Methods We used a two-arm randomized-controlled trial. Following ICU discharge, eligible participants were assigned to one of two groups: music group ( n = 13) or active control group ( n = 13). The music group was taught to self-manage upper and lower extremity exercise movements by listening to an individualized music-guided playlist twice daily for 5 days. The active control group was provided an exercise brochure and advised to perform the same exercises at the same intervals. Dynamometers were used to measure muscle strength. T-tests and Weighted GEE models were used for testing the intervention effect between groups. Results Twenty-six subjects were enrolled. The mean age was 62.8 ( SD = 13.8), 53.8% were male, 65.4% were Caucasian, and the mean APACHE severity of illness score was 59 ( SD = 23.4). Reasons for ICU admission were mainly cardiac and medical. The music group showed significant improvements in handgrip, plantar flexion, leg extension, elbow flexion, and shoulder adduction strengths on left and right sides. Additionally, left and right leg extensor and left plantar flexor strengths showed significant post-differences, and small to moderately large effect sizes, between the music group and control group. Conclusion These findings suggest that a music-guided exercise intervention has the potential to improve muscle strength in ICU survivors and prevent further post-ICU deterioration in ICU survivors. Future trials should build upon these preliminary findings.

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Effect of Tourniquet Use in Ankle Arthroscopic Surgery on Postoperative Recovery: A Prospective Non- Randomized Controlled Study

10.21203/rs.3.rs-89991/v1 ◽

2020 ◽

Author(s):

Tingting Huang ◽

Haixiao Liu ◽

Yuezheng Hu ◽

Xinxian Xu

Keyword(s):

Functional Outcome ◽

Ischemia Reperfusion Injury ◽

Ischemia Reperfusion ◽

Arthroscopic Surgery ◽

Randomized Controlled Study ◽

Controlled Study ◽

Control Group ◽

Complication Rates ◽

Randomized Controlled ◽

The Mean

Abstract The aim of this prospective non- randomized controlled study was to explore the effect of tourniquet use on joint swelling, pain, functional outcome, and tourniquet- related ischemia- reperfusion injury (IRI) during ankle arthroscopic surgery.52 patients who received ankle arthroscopy were allocated to had the procedure done with the tourniquet inflated (the Control group, n= 27) or without the tourniquet inflated (the NT group, n= 25). The main outcome measures were: (1) The amount of swelling of the ankle; (2) Pain as measured by a visual analog scale (VAS); (3) The levels of MDA, IMA,TOS, TAS and OSI at 10 min before incision (T1)，after the completion of surgery (T2), and 30 min after tourniquet deflation (T3); (4) The functional outcome as measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot score; (5) The rate of complication. All patients were reviewed at a mean follow- up of 14.2 months (range, 12- 19 months). The mean circumferences of the ankle in the NT group were significantly lower than those in the Control group on postoperative day 2 and 5 (p<0.05). The mean level of VAS in the Control group was significantly higher on postoperative day 2 (p<0.05). The outcomes of AOFAS ankle hindfoot score were comparable between groups postoperatively (p>0.05). The levels of MDA, IMA, TOS and OSI were all significantly lower in the NT group compared at T2 and T3 (p<0.05), and the level of TAS was significantly lower in the NT group at T3 (p<0.05). The complication rates of two groups were comparable (p>0.05).With the use of tourniquet during ankle arthroscopic surgery, there was increased joint swelling and pain postoperatively, and a trend toward increased levels of MDA, IMA, TOS, TAS and OSI intraoperatively. Thus, we do not recommend using a tourniquet in this type of procedure.

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