Neurofeedback for tinnitus: Study protocol for a single-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, single-blinded randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks post baseline. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first double-blind, randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes not only to our understanding of the neurological underpinnings of tinnitus, but also to the potentiality of neurofeedback as a therapeutic agent.

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Neurofeedback for tinnitus: Study protocol for a randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

10.21203/rs.2.12838/v3 ◽

2020 ◽

Author(s):

Martin Jensen ◽

Eva Hüttenrauch ◽

Jennifer Schmidt ◽

Gerhard Andersson ◽

Mira-Lynn Chavanon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Neurofeedback Training ◽

Sound Perception ◽

Active Comparator ◽

Randomized Controlled ◽

Tinnitus Distress ◽

Training Protocol

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks after the start of the intervention. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes to our understanding of the potentiality of neurofeedback as a treatment for tinnitus.

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Neurofeedback for tinnitus: Study protocol for a double-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

10.21203/rs.2.12838/v1 ◽

2019 ◽

Author(s):

Martin Jensen ◽

Eva Hüttenrauch ◽

Jennifer Schmidt ◽

Gerhard Andersson ◽

Mira-Lynn Chavanon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Neurofeedback Training ◽

Double Blind ◽

Sound Perception ◽

Active Comparator ◽

Randomized Controlled ◽

Tinnitus Distress ◽

Training Protocol

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Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

International Urogynecology Journal ◽

10.1007/s00192-021-04739-5 ◽

2021 ◽

Author(s):

Kari Bø ◽

Lene Anette H. Haakstad ◽

Gøran Paulsen ◽

Anne Mette Rustaden

Keyword(s):

Randomized Controlled Trial ◽

Urinary Incontinence ◽

Strength Training ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Sum Score ◽

New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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Assessment of Cleaning Methods on Bacterial Burden of Hospital Privacy Curtains: A Pilot Randomized Controlled Trial

10.21203/rs.3.rs-583864/v1 ◽

2021 ◽

Author(s):

Kianna Cadogan ◽

Sabrin Bashar ◽

Saul Magnusson ◽

Rakesh Patidar ◽

John Embil ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Bacterial Burden ◽

Randomized Controlled ◽

Route Of Transmission ◽

The Difference ◽

Cluster Randomized ◽

Cleaning Methods

Abstract Healthcare-associated infections (HAIs) are an important global issue, leading to poor patient outcomes. A potential route of transmission of HAIs is through contact with hospital privacy curtains. The aim of this study is to evaluate cleaning on reduction of curtain bacterial burden. In this pilot cluster randomized controlled trial we compared the bacterial burden between three groups of 24 curtains on a regional burn/plastic surgery ward. A control group was not cleaned. Two groups were cleaned at three to four day intervals with either disinfectant spray or wipe. The primary outcome was the difference in mean CFU/cm 2 between day 0 to day 21. The secondary outcome was the proportion of curtains contaminated with Methicillin-resistant Staphylococcus aureus (MRSA). By day 21, the control group was statistically higher (2.2 CFU/cm2) than spray (1.3 CFU/cm2) or wipe (1.5 CFU/cm2) (p < 0.05). After cleaning at three to four day intervals, the bacterial burden on the curtains reduced to near day 0 levels; however, this increased over the intervening three to four days. By day 21, 64% of control curtains were contaminated with MRSA compared to 10% (spray) and 5% (wipe) (p < 0.05). This study show that curtains start clean and progressively become contaminated with bacteria. Regularly cleaning curtains with disinfectant spray or wipes reduces bacterial burden and MRSA contamination.

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Randomized Controlled Trial of Probiotic PS128 in Children with Tourette Syndrome

Nutrients ◽

10.3390/nu13113698 ◽

2021 ◽

Vol 13 (11) ◽

pp. 3698

Author(s):

Chang-Chun Wu ◽

Lee-Chin Wong ◽

Chia-Jui Hsu ◽

Chianne-Wen Yang ◽

Ying-Chieh Tsai ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Tourette Syndrome ◽

Performance Test ◽

Controlled Trial ◽

Continuous Performance Test ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

Social Environmental

Tourette syndrome results from a complex interaction between social–environmental factors, multiple genetic abnormalities, and neurotransmitter disturbances. This study is a double-blinded, randomized controlled trial using probiotics Lactobacillus plantarum PS128 as an intervention to examine if probiotics improve symptoms of children with Tourette syndrome. This study enrolled children aged 5 to 18 years old who fulfilled DSM-V diagnostic criteria for Tourette syndrome. Patients were assessed before initiating the trial, at one month, and at two months after randomization. The primary outcome was evaluated by Yale Global Tic Severity Scale (YGTSS), and the secondary outcome studied the possible comorbidities in these children. The results revealed no significant difference in improvement in YGTSS between the control group and the PS128 group. As for secondary endpoints, an analysis of Conners’ Continuous Performance Test (CPT) showed improvement in commission and detectability in the PS128 group. In conclusion, although probiotics may not have tic-reducing effects in children with Tourette syndrome, it may have benefits on comorbidities such as attention deficit and hyperactivity disorder (ADHD). Further studies are needed to clarify the effects of probiotics on the comorbidities of Tourette syndrome children.

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The effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

10.2196/preprints.32123 ◽

2021 ◽

Author(s):

Leonieke W Kranenburg ◽

Jamie Gillis ◽

Birgit Mayer ◽

Witte JG Hoogendijk

Keyword(s):

Randomized Controlled Trial ◽

Perceived Stress ◽

Psychological Symptoms ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Dutch Population ◽

Randomized Controlled ◽

Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

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Possible Role of Court-Type Thai Traditional Massage During Parturition: a Randomized Controlled Trial

International Journal of Therapeutic Massage & Bodywork Research Education & Practice ◽

10.3822/ijtmb.v12i1.422 ◽

2019 ◽

Vol 12 (1) ◽

pp. 23-28

Author(s):

Panya Sananpanichkul, MD ◽

Chatchai Sawadhichai, MD, PhD ◽

Yosapon Leaungsomnapa, PhD ◽

Paweena Yapanya, BATM

Keyword(s):

Randomized Controlled Trial ◽

Pain Relief ◽

Pain Score ◽

Controlled Trial ◽

Active Phase ◽

Secondary Outcome ◽

Control Group ◽

P Value ◽

Second Stage ◽

Randomized Controlled

Background and Objectives: Court-type Thai traditional Massage (c-TTM) applied during intrapartum may have some benefit other than pain relief. This study aimed to evaluate the effect of c-TTM during the first and second stage of labor, as well as pain alleviation in the first stage.Methods: This was a randomized controlled trial study. Eligible participants were singleton pregnant mothers with cervical dilation between 3–5 cm and no medical complications. Both trial groups received the same routine antepartum care except for 1 hour additional c-TTM given to the experimental group when they were in the active phase of labor. The pain score was taken from the participants at the time before labor pains started, at the time of active labor, 1, 2, 3, and 4 hours after the intervention. Pain was recorded by the researcher using a visual analog scale. The primary outcome during the first and second stages of labor was compared between groups. Pain relief during the first stage of labor and analgesic drugs used were compared as a secondary outcome. This trial is registered under the identification number TCTR20171115003.Results: Fifty-nine participants were enrolled and randomly assigned with 1:1 allocation to groups. The duration of first and second stage labor was significantly shorter in the experimental c-TTM than in the conventional control group (mean ± SD: 198.37 ± 62.80 minutes: 268.52 ± 137.81 minutes, p value =.02 and 17.54 ± 9.49 minutes: 23.35 ± 15.01 minutes, p value =.03, re-spectively). There was no difference of pain score between the groups.Conclusion: One hour of c-TTM can signifi-cantly decrease the duration of the first and second stages of labor. The pain score recorded is not statistically different between the groups.

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Efficacy of acetaminophen with and without oxycodone for analgesia in nonoperative treatment of extremity fractures in adults: Protocol for a double-blind randomized clinical trial

10.21203/rs.2.317/v1 ◽

2019 ◽

Author(s):

Tao Gao ◽

Hongyi Zhu ◽

Changqing Zhang ◽

Yimin Chai ◽

Cheng Guo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Nonoperative Treatment ◽

Secondary Outcome ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Limb Fracture ◽

Self Rating ◽

Limb Fractures

Abstract Background: Opioids and acetaminophen are both widely used to relieve pain after nonoperative treatment of limb fractures, but evidence for superiority of opioids versus acetaminophen is lacking. In this study we aim to determine whether acetaminophen is noninferior to the acetaminophen/oxycodone combination for pain relief after nonoperative fixation of an extremity limb fracture. We hypothesize that acetaminophen is noninferior to the acetaminophen/oxycodone combination. Methods: A double-blind, randomized controlled trial will be conducted. Power analysis determined that 1,226 participants will be needed (p<0.05, power 90%). Patients with acute limb fracture who receive nonoperative treatment will be recruited and randomly allocated into two groups: the intervention group will receive oral oxycodone (5 mg)/acetaminophen (325 mg), and the control group will receive acetaminophen (650 mg) only. The primary outcome measure will be scores on the 11-point Numeric Rating Scale (NRS-11) over 14 days. Secondary outcome measures are scores on the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), EuroQol five dimensions’ questionnaire (EQ-5d), self-rated satisfaction with the analgesia produced, self-reported nighttime sleep duration, number of intervention or control pills used, total duration for taking intervention or control medication. Change of pain scores and the number of times that analgesic drugs were taken in the two groups will be statistically evaluated with t-student tests according to their fracture site. Discussion: This study will be a randomized controlled trial that is adequately powered to test the hypothesis that acetaminophen is noninferior to the combination of acetaminophen and oxycodone in relieving objectively measured pain after nonoperative treatment of limb fractures in adults. It is hopeful to provide a safe and effective analgesic plan for such patients. Trial Registration: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018. Keywords: Opioids, acetaminophen, fracture, nonoperative treatment.

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Immediate effect of an acupressure strap simulating wrist-ankle acupuncture on menstrual pain in young women: study protocol for a randomized controlled trial

10.21203/rs.2.13360/v1 ◽

2019 ◽

Author(s):

Shu-jie Zhai ◽

Yi Ruan ◽

Yue Liu ◽

Zhen Lin ◽

Chen Xia ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Outcome Measures ◽

Analgesic Effect ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Pain Intensity Score ◽

Primary Dysmenorrhea ◽

Randomized Controlled

Abstract Background: Dysmenorrhea seriously affects the ability to perform normal social activities and decreases quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. Methods: The study will be a randomized controlled trial conducted from 1 May 2019 30 May 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into two groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the non-acupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 min on the first day of menstruation. The main outcome measures are the pain intensity score measured by the visual analogue scale, and the onset time of analgesia. The secondary outcome measures are the pain threshold at Yinlingquan (SP 9) , skin temperature at Guanyuan (CV 4) , and expectations and satisfaction of patients as investigated via the Expectation and Treatment Credibility Scale. Discussion: This trial will be the first study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the strict randomization, non-acupressure control, and blinded design. The results may provide a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900021727. Registered on 7 March 2019. http://www.chictr.org.cn/listbycreater.aspx

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Abstract 17680: Effectiveness of a New Smartphone Application “AED-SOS” to Call Co-rescuers Carrying an AED for Cardiac Arrests: A Randomized Controlled Trial

Circulation ◽

10.1161/circ.132.suppl_3.17680 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Toshihiro Hatakeyama ◽

Chika Nishiyama ◽

Tomonari Shimamoto ◽

Kosuke Kiyohara ◽

Tetsuhisa Kitamura ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Smartphone Application ◽

Travel Distance ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Lay Persons ◽

Application Data ◽

Study Participants

[Introduction] Although earlier shock with an automated external defibrillator (AED) is the key to increase survival after out-of-hospital cardiac arrests (OHCA), it is not easy to find out an AED in emergency settings. We recently developed a new smartphone application “AED-SOS.” This application sends a special signal to the smartphone of potential co-rescuers existing in the neighborhood and indicates the OHCA scene and AED locations on the display. According to these notifications, co-rescuers find out and deliver an AED to the OHCA scene. [Objective] To elucidate how this new application can shorten the process to find out an AED and bring it to the OHCA scene. [Methods] Design: Randomized controlled trial (UMIN000016506). Participants: Lay persons aged 18 years or older. Randomization: Participants were randomly assigned to either the AED-SOS group or the control group using permuted blocks after stratification by sex. Intervention: We provided an OHCA scenario to the study participants of both groups. Participants assigned to the AED-SOS group were encouraged to use the AED-SOS application. Data collection: We observed the process until the participants or their co-rescuers brought an AED to the scene. Outcomes: The primary outcome was the time from the recognition of OHCA to AED delivery by either the participant or the co-rescuers. The secondary outcome was their travel distance. [Results] Among 61 participants enrolled, 52 were analyzed. The time from recognition of OHCA to AED delivery was significantly shorter in the AED-SOS group than in the control group (133.6±44.4 versus 202.2±122.2, p=0.01). The travel distance was similar between the groups (Table). [Conclusion] The smartphone application to prompt potential co-rescuers in the neighborhood to deliver an AED, would shorten the time from recognition of OHCA to AED delivery. It will help increase the survivors after OHCA.

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