scholarly journals Individualized PEEP titration guided by intratidal compliance profile analysis improves regional ventilation – a randomized controlled trial

2019 ◽  
Author(s):  
Jonas Weber ◽  
Jan Gutjahr ◽  
Johannes Schmidt ◽  
Sara Lozano-Zahonero ◽  
Silke Borgmann ◽  
...  
Keyword(s):  
Respiratory System ◽  
Elective Surgery ◽  
Profile Analysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Regional Ventilation ◽  
Randomized Controlled ◽  
Hemodynamic Variables ◽  
Ventilation Setting

Abstract Background Application of positive end-expiratory pressure (PEEP) improves lung aeration and reduces mechanical stress during mechanical ventilation. Although numerous approaches for PEEP titration have been proposed, there is no accepted strategy to titrate optimal PEEP. By analyzing the intratidal compliance profiles, PEEP may be titrated patient-individually. Methods After obtaining informed consent, we measured respiratory system mechanics, regional ventilation in 60 consecutive patients undergoing elective surgery, randomly allocated to the control group (PEEP = 5 cmH2O) or the intervention group receiving individually titrated PEEP, guided by intratidal compliance profile analysis. Primary endpoint was the frequencies of nonlinear intratidal compliance (CRS) profiles of the respiratory system (horizontal, increasing, decreasing and mixed). We further investigated respiratory and hemodynamic variables and regional ventilation. Results Frequencies of CRS profiles were comparable between the groups. Besides PEEP [control: 5.0 (0.0), intervention: 5.8 (1.1) cmH2O, p<0.001] respiratory and hemodynamic variables were comparable between the two groups. The compliance profile analysis showed no significant differences between the two groups. The loss of ventral and dorsal regional ventilation was higher in the control [ventral: 41.0 (16.3) %, dorsal: 25.9 (13.9) %] than in the intervention group [ventral: 29.3 (17.6) %, dorsal: 16.4 (12.7) %, p (ventral) = 0.039, p (dorsal) = 0.028]. Conclusions Individualized PEEP titration according to bedside compliance profile analysis improves regional ventilation without affecting respiratory and hemodynamic variables negatively and may be a promising approach to patient-individual ventilation setting.

scholarly journals Effect of individualized PEEP titration guided by intratidal compliance profile analysis on regional ventilation assessed by electrical impedance tomography – a randomized controlled trial

2019 ◽  
Author(s):  
Jonas Weber ◽  
Jan Gutjahr ◽  
Johannes Schmidt ◽  
Sara Lozano-Zahonero ◽  
Silke Borgmann ◽  
...  
Keyword(s):  
Respiratory System ◽  
Elective Surgery ◽  
Profile Analysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Regional Ventilation ◽  
Impedance Tomography ◽  
Randomized Controlled ◽  
Hemodynamic Variables

Abstract Background Application of positive end-expiratory pressure (PEEP) improves lung aeration and reduces mechanical stress during mechanical ventilation. Although numerous approaches for PEEP titration have been proposed, there is no accepted strategy to titrate optimal PEEP. By analyzing the intratidal compliance profiles, PEEP may be titrated patient-individually. Methods After obtaining informed consent, we measured respiratory system mechanics, regional ventilation in 60 consecutive patients undergoing elective surgery, randomly allocated to the control group (PEEP = 5 cmH 2 O) or the intervention group receiving individually titrated PEEP, guided by intratidal compliance profile analysis. Primary endpoint was the frequencies of nonlinear intratidal compliance (C RS ) profiles of the respiratory system (horizontal, increasing, decreasing and mixed). We further investigated respiratory and hemodynamic variables and regional ventilation. Results Frequencies of C RS profiles were comparable between the groups. Besides PEEP [control: 5.0 (0.0), intervention: 5.8 (1.1) cmH 2 O, p<0.001] respiratory and hemodynamic variables were comparable between the two groups. The compliance profile analysis showed no significant differences between the two groups. The loss of ventral and dorsal regional ventilation was higher in the control [ventral: 41.0 (16.3) %, dorsal: 25.9 (13.8) %] than in the intervention group [ventral: 29.3 (17.6) %, dorsal: 16.4 (12.7) %, p (ventral) = 0.039, p (dorsal) = 0.028]. Conclusions Individualized PEEP titration according to bedside compliance profile analysis improves regional ventilation in terms of global aeration gain without affecting respiratory and hemodynamic variables negatively and might be a promising approach to patient-individual ventilation settings. However, differences in dorsal to ventral ventilation distribution were not found. Unfavorable compliance profiles indicating tidal derecruitment were found less often than in earlier studies.

scholarly journals Individualized PEEP titration guided by intratidal compliance profile analysis improves regional ventilation – a randomized controlled trial

2019 ◽  
Author(s):  
Jonas Weber ◽  
Jan Gutjahr ◽  
Johannes Schmidt ◽  
Sara Lozano-Zahonero ◽  
Silke Borgmann ◽  
...  
Keyword(s):  
Elective Surgery ◽  
Profile Analysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Ventilation Distribution ◽  
Regional Ventilation ◽  
Randomized Controlled ◽  
Hemodynamic Variables ◽  
Ventilation Setting

Abstract Background Application of positive end-expiratory pressure (PEEP) improves lung aeration and reduces mechanical stress during mechanical ventilation. Although numerous approaches for PEEP titration have been proposed, there is no accepted strategy to titrate optimal PEEP. By analyzing the intratidal compliance profiles, PEEP may be titrated patient-individually. Methods After obtaining informed consent, we measured respiratory system mechanics and regional ventilation in 60 consecutive patients undergoing elective surgery, randomly allocated to the control group (PEEP = 5 cmH 2 O) or the intervention group receiving individually titrated PEEP, guided by intratidal compliance profile analysis. Primary endpoint was the nonlinear intratidal compliance. We further investigated respiratory and hemodynamic variables, regional ventilation and compliance profiles. Results Compliance was comparable between control [63.2 (14.0) mL·cmH 2 O -1 ] and intervention group [67.8 (15.9) mL·cmH 2 O -1 , p = 0.271]. Besides PEEP [control: 5.0 (0.0), intervention: 5.8 (1.1) cmH 2 O] respiratory and hemodynamic variables were comparable between the two groups. The compliance profile analysis showed no significant differences between the two groups. Relative thoracic electrical impedance was better maintained in the intervention group (89.3 (19.4) %) than in the control group (78.3 (23.6) %, p < 0.001). No significant differences in dorsal to ventral ventilation distribution was found between the two groups. Conclusions Individualized PEEP titration according to bedside compliance profile analysis improves regional ventilation without affecting respiratory and hemodynamic variables negatively and may be a promising approach to patient-individual ventilation setting.

scholarly journals Effect of individualized PEEP titration guided by intratidal compliance profile analysis on regional ventilation assessed by electrical impedance tomography – a randomized controlled trial

2020 ◽  
Author(s):  
Jonas Weber ◽  
Jan Gutjahr ◽  
Johannes Schmidt ◽  
Sara Lozano-Zahonero ◽  
Silke Borgmann ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Electrical Impedance Tomography ◽  
Electrical Impedance ◽  
Profile Analysis ◽  
Intervention Group ◽  
Dynamic Strain ◽  
Control Group ◽  
Regional Ventilation ◽  
Impedance Tomography ◽  
Hemodynamic Variables

Abstract Background The application of positive end-expiratory pressure (PEEP) may reduce dynamic strain during mechanical ventilation. Although numerous approaches for PEEP titration have been proposed, there is no accepted strategy for titrating optimal PEEP. By analyzing intratidal compliance profiles, PEEP may be individually titrated for patients. Methods After obtaining informed consent, 60 consecutive patients undergoing general anesthesia were randomly allocated to mechanical ventilation with PEEP 5 cmH 2 O (control group) or PEEP individually titrated, guided by an analysis of the intratidal compliance profile (intervention group). The primary endpoint was the frequency of each nonlinear intratidal compliance (C RS ) profile of the respiratory system (horizontal, increasing, decreasing, and mixed). The secondary endpoints measured were respiratory mechanics, hemodynamic variables, and regional ventilation, which was assessed via electrical impedance tomography. Results The frequencies of the C RS profiles were comparable between the groups. Besides PEEP [control: 5.0 (0.0), intervention: 5.8 (1.1) cmH 2 O, p < 0.001], the respiratory and hemodynamic variables were comparable between the two groups. The compliance profile analysis showed no significant differences between the two groups. The loss of ventral and dorsal regional ventilation was higher in the control [ventral: 41.0 (16.3)%; dorsal: 25.9 (13.8)%] than in the intervention group [ventral: 29.3 (17.6)%; dorsal: 16.4 (12.7)%; p (ventral) = 0.039, p (dorsal) = 0.028]. Conclusions Unfavorable compliance profiles indicating tidal derecruitment were found less often than in earlier studies. Individualized PEEP titration resulted in slightly higher PEEP. A slight global increase in aeration associated with this was indicated by regional gain and loss analysis. Differences in dorsal to ventral ventilation distribution were not found.

scholarly journals Effect of individualized PEEP titration guided by intratidal compliance profile analysis on regional ventilation assessed by electrical impedance tomography – a randomized controlled trial

2020 ◽  
Author(s):  
Jonas Weber ◽  
Jan Gutjahr ◽  
Johannes Schmidt ◽  
Sara Lozano-Zahonero ◽  
Silke Borgmann ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Electrical Impedance Tomography ◽  
Electrical Impedance ◽  
Profile Analysis ◽  
Intervention Group ◽  
Dynamic Strain ◽  
Control Group ◽  
Regional Ventilation ◽  
Impedance Tomography ◽  
Hemodynamic Variables

Abstract Background The application of positive end-expiratory pressure (PEEP) may reduce dynamic strain during mechanical ventilation. Although numerous approaches for PEEP titration have been proposed, there is no accepted strategy for titrating optimal PEEP. By analyzing intratidal compliance profiles, PEEP may be individually titrated for patients. Methods After obtaining informed consent, 60 consecutive patients undergoing general anesthesia were randomly allocated to mechanical ventilation with PEEP 5 cmH2O (control group) or PEEP individually titrated, guided by an analysis of the intratidal compliance profile (intervention group). The primary endpoint was the frequency of each nonlinear intratidal compliance (CRS) profile of the respiratory system (horizontal, increasing, decreasing, and mixed). The secondary endpoints measured were respiratory mechanics, hemodynamic variables, and regional ventilation, which was assessed via electrical impedance tomography. Results The frequencies of the CRS profiles were comparable between the groups. Besides PEEP [control: 5.0 (0.0), intervention: 5.8 (1.1) cmH2O, p < 0.001], the respiratory and hemodynamic variables were comparable between the two groups. The compliance profile analysis showed no significant differences between the two groups. The loss of ventral and dorsal regional ventilation was higher in the control [ventral: 41.0 (16.3)%; dorsal: 25.9 (13.8)%] than in the intervention group [ventral: 29.3 (17.6)%; dorsal: 16.4 (12.7)%; p (ventral) = 0.039, p (dorsal) = 0.028]. Conclusions Unfavorable compliance profiles indicating tidal derecruitment were found less often than in earlier studies. Individualized PEEP titration resulted in slightly higher PEEP. A slight global increase in aeration associated with this was indicated by regional gain and loss analysis. Differences in dorsal to ventral ventilation distribution were not found.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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

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.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sara Mahmoodi ◽  
Mojtaba Yousefi ◽  
Omid Sadeghi ◽  
Ali Mahmoodabadi ◽  
Mohammadreza Sadriirani ◽  
...  
Keyword(s):  
Green Tea ◽  
Controlled Trial ◽  
Intervention Group ◽  
Total Sample ◽  
Control Group ◽  
List Type ◽  
Disease Symptoms ◽  
Laboratory Parameters ◽  
Randomized Controlled ◽  
Full Protocol

Abstract Objectives The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection. Trial design Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study Participants We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants’ inclusion criteria are as follows: Inclusion Criteria Patients aged ≥18 years COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR) Exclusion Criteria Pregnancy or lactation Disseminated intravascular coagulation or any other types of coagulopathy Severe congestive kidney failure Having a history of participating in a clinical trial during the last 30 days Intervention and comparator Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days. Main outcomes Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group. Randomisation Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers (Randomization.com) Blinding (masking) The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study. Numbers to be randomised (sample size) The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required. Trial Status The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021. Trial registration IRCT20150711023153N3 (https://www.irct.ir/trial/55948) retrospectively registered on June 4, 2021 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting was eliminated; this Letter serves as a summary of the key elements of the full protocol.

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