Auricular Vagus Nerve Acupressure for Patients with Emotional Distress under the COVID-19 Pandemic: A Smartphone-based, Randomized，Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Peijing Rong ◽  
Lei Wang ◽  
Lingling Yu ◽  
Junying Wang ◽  
Yan Ma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vagus Nerve ◽  
Emotional Distress ◽  
Response Rate ◽  
Controlled Trial ◽  
Depression Scale ◽  
Randomized Controlled ◽  
Falling Asleep ◽  
Global Spread ◽  
Study Sites

BACKGROUND The global spread of the 2019 coronavirus diseases (COVID-19) has caused emotional distress. However, whether auricular vagus nerve acupressure (AVNA) is effective in improving emotional distress under the COVID-19 has not been well-documented. OBJECTIVE To confirm whether AVNA is effective in improving emotional distress under the COVID-19 pandemic. METHODS A smartphone-based online, randomized, controlled trial was designed in four study sites, including Wuhan, Beijing, Shenyang, and Guangzhou of China, from 26 February 2020 to 28 April 2020. Participants were randomly assigned to three times of AVNA (n = 191) or usual care (UC, n = 215) for 14 days. The primary outcome was the response rate, which was the proportion of participants whose Hospital Anxiety and Depression Scale (HADS) score reduced from baseline by ≥ 50%. The assessment was conducted at baseline, 3 days, and 14 days. RESULTS The AVNA group had a markedly higher response rate than the UC group at 3 days (35.6% vs. 24.9%, P = 0.02) and at 14 days (70.7% vs. 60.6%, P = 0.02). The AVNA group showed significantly greater reduction in score of HADS at the two measurement points and BAI at 3 days (P ≤ 0.03), with average respective effect size of 0.217 and 0.195. Participants with AVNA spent less time falling asleep and rated their sleep quality being remarkably higher than those with UC at endpoint. CONCLUSIONS AVNA can be recommended for patients with emotional distress under the current COVID-19 pandemic and other emergent events. CLINICALTRIAL www.chictr.org.cn Identifier: ChiCTR2000030078.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

Effectiveness of an occupational therapy intervention in reducing emotional distress in informal caregivers of hip fracture patients: a randomized controlled trial

2014 ◽  
Vol 28 (8) ◽  
pp. 772-783 ◽  
Author(s):  
Lydia M Martín-Martín ◽  
Gerald Valenza-Demet ◽  
Patrocinio Ariza-Vega ◽  
Carmen Valenza ◽  
Yolanda Castellote-Caballero ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hip Fracture ◽  
Occupational Therapy ◽  
Emotional Distress ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Randomized Controlled ◽  
Occupational Therapy Intervention ◽  
Therapy Intervention

scholarly journals The Effects of a Mindfulness-Based Intervention on Emotional Distress, Quality of Life, and HbA1c in Outpatients With Diabetes (DiaMind): A randomized controlled trial

Diabetes Care ◽  
2012 ◽  
Vol 36 (4) ◽  
pp. 823-830 ◽  
Author(s):  
J. van Son ◽  
I. Nyklicek ◽  
V. J. Pop ◽  
M. C. Blonk ◽  
R. J. Erdtsieck ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Emotional Distress ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Comparing a Mobile Phone Automated System With a Paper and Email Data Collection System: Substudy Within a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Diana M Bond ◽  
Jeremy Hammond ◽  
Antonia W Shand ◽  
Natasha Nassar
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Cost Analysis ◽  
Mobile Phone ◽  
Response Rate ◽  
Controlled Trial ◽  
Treatment Compliance ◽  
Automated System ◽  
Collection System ◽  
Randomized Controlled

BACKGROUND Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes. OBJECTIVE The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women. METHODS We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods. RESULTS Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; <i>P</i>&lt;.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; <i>P</i>&lt;.001) and a higher recommendation rate for future use (95% vs 64%; <i>P</i>&lt;.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable. CONCLUSIONS MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.

scholarly journals Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive

2017 ◽  
Vol 14 (4) ◽  
pp. 381-386 ◽  
Author(s):  
Amy J Morgan ◽  
Ronald M Rapee ◽  
Jordana K Bayer
Keyword(s):  
Randomized Controlled Trial ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Response Rate ◽  
Controlled Trial ◽  
Response Rates ◽  
Health Intervention ◽  
Randomized Controlled ◽  
Gift Card

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15–2.79). This response rate increase of 11.1% (95% confidence interval = 2.8–19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07–2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07–1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.

scholarly journals Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

2020 ◽  
Vol 17 (7) ◽  
pp. 2465
Author(s):  
Alfonso Javier Ibáñez-Vera ◽  
Jerónimo Carmelo García-Romero ◽  
José Ramón Alvero-Cruz ◽  
Rafael Lomas-Vega
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sham Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Physical Factor ◽  
Control Group ◽  
Local Pain ◽  
Randomized Controlled ◽  
Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

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