Effectiveness of Optional Videoconferencing-Based Treatment of Alcohol Use Disorders: Randomized Controlled Trial

Background Treatment of alcohol use disorders (AUDs) is characterized by an adherence rate below 50%. Clinical research has found that patient adherence enhances treatment effect; hence, health authorities, clinicians, and researchers strive to explore initiatives contributing to patients receiving treatment. Concurrently, videoconferencing-based treatment is gaining ground within other addiction and psychiatric areas. Objective The aim of this study was to test whether optional videoconferencing increases adherence to and effectiveness of AUD treatment in a randomized controlled trial (RCT). We hypothesized that the intervention would decrease premature dropout (the primary outcome), as well as increase successful treatment termination, treatment duration, and treatment outcome (secondary outcomes). Methods We conducted this study in the public outpatient alcohol clinic in Odense, Denmark, between September 2012 and April 2013. It was an RCT with 2 groups: treatment as usual (TAU) and treatment as usual with add-on intervention (TAU+I). The TAU+I group had the option, from session to session, to choose to receive treatment as usual via videoconferencing. Data consisted of self-reported responses to the European version of the Addiction Severity Index (EuropASI). We collected data at baseline, at follow-up at 3, 6, and 12 months, and at discharge. Results Among consecutive patients attending the clinic, 128 met the inclusion criteria, and 71 of them were included at baseline. For the primary outcome, after 180 days, 2 of 32 patients (6%) in the TAU+I group and 12 of 39 patients (31%) in the TAU group had dropped out prematurely. The difference is significant (P=.008). After 365 days, 8 patients (25%) in the TAU+I group and 17 patients (44%) in the TAU group had dropped out prematurely. The difference is significant (P=.02). For the secondary outcomes, significantly more patients in the TAU+I group were still attending treatment after 1 year (P=.03). We found no significant differences between the 2 groups with regard to successful treatment termination and treatment outcome. Conclusions The results indicate that offering patients optional videoconferencing may prevent premature dropouts from treatment and prolong treatment courses. However, the small sample size precludes conclusions regarding the effect of the intervention, which was not detectable in the patients’ use of alcohol and severity of problems. Trial Registration The Regional Health Research Ethics Committee System in Denmark: S-20110052; https://komite.regionsyddanmark.dk/wm258128 (Archived by WebCite at http://www.webcitation.org/6tTL3CO6u)

Download Full-text

A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

Scientific Reports ◽

10.1038/s41598-021-92242-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Lara Bücker ◽

Josefine Gehlenborg ◽

Steffen Moritz ◽

Stefan Westermann

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Primary Outcome ◽

Controlled Trial ◽

Group Differences ◽

Control Group ◽

Gambling Problems ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

Download Full-text

An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/14648 ◽

2019 ◽

Vol 6 (10) ◽

pp. e14648 ◽

Cited By ~ 9

Author(s):

Peter Johansson ◽

Mats Westas ◽

Gerhard Andersson ◽

Urban Alehagen ◽

Anders Broström ◽

...

Keyword(s):

Cardiovascular Disease ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Primary Outcome ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

Download Full-text

Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.19881 ◽

2020 ◽

Cited By ~ 1

Author(s):

Angela A T Schuurmans ◽

Karin S Nijhof ◽

Ron Scholte ◽

Arne Popma ◽

Roy Otten

Keyword(s):

Randomized Controlled Trial ◽

Posttraumatic Stress ◽

Controlled Trial ◽

Self Report ◽

Treatment As Usual ◽

Randomized Controlled ◽

Posttraumatic Symptoms ◽

Secondary Outcomes ◽

Anxiety Depression

BACKGROUND Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. OBJECTIVE This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. METHODS This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. RESULTS The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. CONCLUSIONS Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. CLINICALTRIAL Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19881

Download Full-text

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

10.21203/rs.2.475/v2 ◽

2019 ◽

Author(s):

Jian-Feng Tu ◽

Jing-Wen Yang ◽

Li-Qiong Wang ◽

Yang Wang ◽

Jin-ling Li ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Statistical Analysis ◽

Knee Osteoarthritis ◽

Primary Outcome ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Sham Acupuncture ◽

Manual Acupuncture ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background: Acupuncture therapies are widely used for knee osteoarthritis (KOA), despite contradictory evidences. Current study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. Methods/design: Current study is a multi-center, three-arm, randomized controlled trial which will enroll 480 participants with KOA in China. Participants will be randomly assigned (1:1:1) to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate - the proportion of patients who simultaneously achieve minimal clinically important improvement in pain and function domains at 8 weeks. The primary outcome will be analyzed using Z-test with intention-to-treat set. Secondary outcomes contain pain, function, global patient assessment and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. Discussion: The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and enhance the transparency of current trial. The trial will provide high-quality evidence on the efficacy of acupuncture for KOA.

Download Full-text

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

International Journal of Social Psychiatry ◽

10.1177/0020764017693652 ◽

2017 ◽

Vol 63 (3) ◽

pp. 212-223 ◽

Cited By ~ 7

Author(s):

Abdalhadi Hasan ◽

Mahmoud Musleh

Keyword(s):

Randomized Controlled Trial ◽

Psychiatric Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Post Intervention ◽

Treatment As Usual ◽

Randomized Controlled ◽

Secondary Outcomes ◽

The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

Download Full-text

Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial

10.21203/rs.3.rs-305564/v1 ◽

2021 ◽

Author(s):

Jing-wen Sun ◽

Zhi-gang Li ◽

Ming-liang Sun ◽

Da Li ◽

Jun Zhao ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Irritable Bowel Syndrome ◽

Social Adjustment ◽

Primary Outcome ◽

Controlled Trial ◽

Randomized Controlled ◽

Self Rating ◽

Multicenter Randomized Controlled Trial ◽

Secondary Outcomes ◽

Irritable Bowel

Abstract Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease has been found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients based on conventional treatments. We also want to explore the optimal acupoint combination recommended for IBS and clarify the clinical advantage of "multi-acupoint co-effect and synergistic effect".Methods and analysis: A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly allocated to receive different acupuncture. Each patient will receive 12 acupuncture treatments over four weeks and will be followed up for four weeks. The primary outcome is the IBS-symptom severity score (IBS-SSS). The secondary outcomes include the Bristol stool form scale(BSFS), the work and social adjustment score (WSAS), the IBS-quality of life (IBS-QOL), self-rating anxiety scale (SAS), and the self-rating depression scale (SDS). Both the primary outcome and the secondary outcomes measures are collected at baseline, 2 weeks, and 4 weeks of the intervention, 6 weeks, and 8 weeks after the intervention.Ethics and dissemination: The entire project has been approved by the ethics committee of Beijing University of Chinese Medicine ( 2020BZYLL0903 ) .Discussion: This is a multicenter randomized controlled trial for IBS in China. This may shed light on the efficacy of acupuncture as an alternative to IBS. The results of the trial will be disseminated in peer-reviewed publications. Trial registration: Chinese Clinical Trials Register, ID: ChiCTR2000041215.First registered on 12 December 2020. http://www.chictr.org.cn/.

Download Full-text

Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/19881 ◽

2020 ◽

Vol 9 (9) ◽

pp. e19881 ◽

Cited By ~ 1

Author(s):

Angela A T Schuurmans ◽

Karin S Nijhof ◽

Ron Scholte ◽

Arne Popma ◽

Roy Otten

Keyword(s):

Randomized Controlled Trial ◽

Posttraumatic Stress ◽

Controlled Trial ◽

Self Report ◽

Treatment As Usual ◽

Randomized Controlled ◽

Posttraumatic Symptoms ◽

Secondary Outcomes ◽

Anxiety Depression

Background Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 International Registered Report Identifier (IRRID) DERR1-10.2196/19881

Download Full-text

LO45: Does the use of point of care ultrasonography improve survival in emergency department patients with undifferentiated hypotension? The first Sonography in Hypotension and Cardiac Arrest in the Emergency Department (SHOC-ED1) Study; an international randomized controlled trial

CJEM ◽

10.1017/cem.2017.107 ◽

2017 ◽

Vol 19 (S1) ◽

pp. S43

Author(s):

P.R. Atkinson ◽

J. Milne ◽

L. Diegelmann ◽

H. Lamprecht ◽

M. Stander ◽

...

Keyword(s):

Emergency Department ◽

Randomized Controlled Trial ◽

Length Of Stay ◽

Diagnostic Accuracy ◽

Standard Care ◽

Primary Outcome ◽

Point Of Care ◽

Controlled Trial ◽

Randomized Controlled ◽

Secondary Outcomes

Introduction: Point of care ultrasound (PoCUS) is an established tool in the initial management of patients with undifferentiated hypotension in the emergency department (ED). While PoCUS protocols have been shown to improve early diagnostic accuracy, there is little published evidence for any mortality benefit. We report the findings from our international multicenter randomized controlled trial, assessing the impact of a PoCUS protocol on survival and key clinical outcomes. Methods: Recruitment occurred at 7 centres in North America (4) and South Africa (3). Scans were performed by PoCUS-trained physicians. Screening at triage identified patients (SBP<100 or shock index>1), randomized to PoCUS or control (standard care and no PoCUS) groups. Demographics, clinical details and study findings were collected prospectively. Initial and secondary diagnoses were recorded at 0 and 60 minutes, with ultrasound performed in the PoCUS group prior to secondary assessment. The primary outcome measure was 30-day/discharge mortality. Secondary outcome measures included diagnostic accuracy, changes in vital signs, acid-base status, and length of stay. Categorical data was analyzed using Fishers test, and continuous data by Student T test and multi-level log-regression testing. (GraphPad/SPSS) Final chart review was blinded to initial impressions and PoCUS findings. Results: 258 patients were enrolled with follow-up fully completed. Baseline comparisons confirmed effective randomization. There was no difference between groups for the primary outcome of mortality; PoCUS 32/129 (24.8%; 95% CI 14.3-35.3%) vs. Control 32/129 (24.8%; 95% CI 14.3-35.3%); RR 1.00 (95% CI 0.869 to 1.15; p=1.00). There were no differences in the secondary outcomes; ICU and total length of stay. Our sample size has a power of 0.80 (α:0.05) for a moderate effect size. Other secondary outcomes are reported separately. Conclusion: This is the first RCT to compare PoCUS to standard care for undifferentiated hypotensive ED patients. We did not find any mortality or length of stay benefits with the use of a PoCUS protocol, though a larger study is required to confirm these findings. While PoCUS may have diagnostic benefits, these may not translate into a survival benefit effect.

Download Full-text

POS0844 EFFECTS OF SERIAL LOCALLY APPLIED WATER-FILTERED INFRARED A RADIATION IN PATIENTS WITH SYSTEMIC SCLEROSIS WITH SEVERE RAYNAUD’S SYNDROME RECEIVING PROSTAGLANDINE TREATMENT – A RANDOMIZED CONTROLLED TRIAL

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1735 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 676.1-676

Author(s):

P. Klemm ◽

J. Bär ◽

I. Aykara ◽

K. Frommer ◽

E. Neumann ◽

...

Keyword(s):

Wound Healing ◽

Randomized Controlled Trial ◽

Systemic Sclerosis ◽

Primary Outcome ◽

Controlled Trial ◽

Standard Of Care ◽

Hyperthermia Treatment ◽

Applied Water ◽

Randomized Controlled ◽

Secondary Outcomes

Background:More than 95% of patients with systemic sclerosis (SSc) suffer from Raynaud’s syndrome (RS) leading to digital ulcerations (DU). In severe RS, intravenous application of prostaglandins is required. Moreover, these patients profit from an additional non-pharmacological treatment using hyperthermia to increase vasodilatation and perfusion, and to reduce pain.Serial locally applied water-filtered infrared A radiation (sl-wIRAR) is a hyperthermia treatment modality using infrared heat radiation in the range of 780-1400nm with high tissue penetration and low thermal load on the skin surface [1]. wIRAR has both, temperature-dependent and non-dependent effects, which do not inherit thermal energy transfer and/or relevant temperature changes [1]. It is therefore not only used in acute and chronic wound healing as it promotes perfusion, alleviates pain and has anti-infectious effects [2], but is also used in oncology [3] and rheumatology [4].Objectives:We conducted a randomized controlled trial with a follow-up visit after 2 weeks to evaluate the value of a high-frequent hyperthermia treatment using sl-wIRAR in comparison to a low-frequent hyperthermia treatment (our standard) in SSc patients with severe RS receiving Iloprost treatment.Methods:Eligible patients had SSc according to the 2013 ACR/EULAR classification criteria, were 18 to 80 years old and had RS requiring treatment with Iloprost in an in-patient setting. Key exclusion criteria were contraindications to any hyperthermia treatment such as infection or heat insensitivity. The trial was conducted at Campus Kerckhoff of Justus-Liebig University Giessen. Eligible patients were equally randomized to the intervention group (IG) receiving additional sl-wIRAR treatment (2 treatments for 30 min per day for 8 days) plus the standard of care (Iloprost treatment over 8 days plus daily carbon dioxide hand baths of 20 min) and the control group (CG) receiving only the standard of care. Primary outcome was the between-group difference in pain measured on a numeric rating scale (NRS) after intervention. Key secondary outcomes included a change in RS frequency, RS duration, and a change in Interleukin (IL) -6 and VEGF levels.Results:From 01.03.2020 to 31.12.2020 49 SSc patients met the inclusion criteria. 42 patients were enrolled (IG: 21, CG: 21). 38 patients (IG:19, CG: 19) completed the full trial period and were analyzed. There was no statistically significant between-group difference in pain levels (NRS) (p=0.284, Z -1.082 (Mann-Whitney U Test)) and thus the primary outcome was not met. Therefore, all p values for secondary outcomes are nominal. Intensity (Visual analogue scale 0-100mm) and duration (min) of RS were reduced in the IG (mean ± standard error) -14.579 ± 7.214 mm (p=0.058) and -2.917 ± 1.510 min (p=0.08), respectively. Intra- and inter-group comparison of IL-6 and VEGF levels showed no relevant change.Conclusion:The additive and frequent use of sl-wIRAR in the treatment of SSc patients with RS requiring Iloprost treatment does not improve outcomes regarding pain levels, RS intensity or frequency nor IL-6 and VEGF levels when compared to Iloprost treatment and low-frequent hyperthermia application.References:[1]Hoffmann G. Clinical applications of water-filtered infrared-A (wIRA) – a review. Phys Med Rehab Kuror. 2017;27(05):265–274.[2]Hoffmann G, Harte M, Mercer JB. Heat for wounds – water-fil- tered infrared-a (wIRA) for wound healing – a review. GMS Ger Med Sci. 2016;14:Doc08.[3]Notter M, Thomsen AR, Nitsche M, et al. Combined wIRA-hyperthermia and hypofractionated re-irradiation in the treatment of locally recurrent breast cancer: evaluation of therapeutic outcome based on a novel size classification. Cancers (Basel). 2020;12(3): 606.[4]Klemm P, Eichelmann M, Aykara I et al. Serial locally applied water-filtered infrared a radiation in axial spondyloarthritis – a randomized controlled trial, International Journal of Hyperthermia, 37:1, 965-970.Acknowledgements:We acknowledge the help of Carina Schreiyäck.This study was in part supported by the Dr. med. h.c. Erwin Braun Foundation, Basel, a charitable, nonprofit Swiss scientific foundation approved by the Swiss Federal Administration. The foundation supports clinical investigation of waterfiltered infrared-A. The foundation was not involved in any content- or decision-related aspect of the study.This study was prospectively registered at www.drks.de (German Registry of Clinical Studies): DRKS00021098Disclosure of Interests:None declared

Download Full-text

Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial

American Journal of Perinatology ◽

10.1055/s-0040-1708851 ◽

2020 ◽

Author(s):

Melissa S. Wong ◽

Brennan M.R. Spiegel ◽

Kimberly D. Gregory

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Pain Score ◽

Primary Outcome ◽

Controlled Trial ◽

Tertiary Care ◽

Obstetric Outcomes ◽

Care Hospital ◽

Randomized Controlled ◽

Secondary Outcomes

Objective Virtual reality (VR) represents a potential method for easing labor pain and in nonpregnant patients has been shown to achieve similar or greater analgesia than hydromorphone. Few studies of VR have been performed in pregnant women. The aim of this randomized controlled trial (RCT) is to evaluate whether VR is effective in reducing pain in laboring women. Study Design An open-label, RCT of nulliparous, term women in labor in a tertiary care hospital. We included women with a pain score level of 4 to 7 having regular contractions at least every 5 minutes. We excluded women who had received any pharmacologic pain relief including neuraxial analgesia and those with contraindications to VR. Participants were randomized to up to 30 minutes of either VR or the control arm (no additional intervention). Our primary outcome was the difference in differences from pre- to postintervention pain score. Prespecified secondary outcomes included postintervention pain scores, duration of intervention use, pharmacologic analgesia use, maternal vitals, and obstetric outcomes. Results From March 2018 to February 2019, 40 subjects were enrolled, randomized, and completed the study; 19 were randomized to control and 21 to the VR arm. Most baseline characteristics were similar between groups. For the primary outcome, those assigned to the control arm had a statistically significant increase in pain of +0.58, while the VR arm had a significant reduction in pain of −0.52 (p = 0.03). There was also a difference in the proportion who had a minimum clinically important difference in pain (0% control and 23.8% VR; p = 0.049). Postintervention maternal heart rate was higher in the control arm (86.8 vs. 76.3, p = 0.01). Most other secondary outcomes did not differ. Conclusion In our study, we found that VR was effective for reducing pain in women in labor as compared with those receiving no intervention. Key Points

Download Full-text