exploratory trial
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2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Lukas Israel ◽  
Gabriele Rotter ◽  
Ulrike Förster-Ruhrmann ◽  
Josef Hummelsberger ◽  
Rainer Nögel ◽  
...  

Abstract Background Acupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients. Methods We conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks. Results Forty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: − 0.9 points (95% CI − 1.6 to − 0.2; p = 0.011) and VAS overall SAR symptoms: − 21.6 mm (95% CI − 36.3 to − 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI − 3.8 to − 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe. Conclusion Results of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014310


2021 ◽  
Vol 13 (22) ◽  
pp. 12920
Author(s):  
Saju Madavanakadu Devassy ◽  
Lorane Scaria ◽  
Kalluparambil Kesavan Shaju ◽  
Natania Cheguvera ◽  
Mannooparambil K. Joseph ◽  
...  

The study explores the effectiveness, feasibility, and acceptability of a befriending intervention delivered by trained lay health workers to address the issues of the rural youth during the COVID-19 pandemic. We did an exploratory trial with 501 upskilled youth, where we randomly recruited 251 to the intervention group (REaCH) and 250 to the control group (General Enquiry Telephone Call-GETC). The outcome variables included in the study were depressive symptoms, wellbeing, and social support. The majority of the participants were females (64.2%), unmarried (63.55%), and hailed from economically poorer households (57.63%). The befriending intervention reduced depressive symptoms (OR: 0.95, p = 0.05) and significantly improved social support (OR: 1.03, p = 0.000) among participants in the intervention group. The participants in the intervention group had higher perceived social support from friends, families, and significant others when compared to the control group. Additionally, suicidality scores decreased for people in the intervention group from baseline to follow up; however, the results were not statistically significant. Befriending intervention is a practical, low-cost technique to sustain the youth in employment and ensure sustainable income. It inspires practitioners and policymakers to create mental health gatekeeping. The trial was registered prospectively on 27 July 2020 in Clinical Trial Registry India; ICMR-NIMS (Registration Number: CTRI/2020/07/026834).


2021 ◽  
Author(s):  
Tim Cheetham ◽  
Michael Cole ◽  
Mario Abinun ◽  
Amit Alalhabadia ◽  
Tim Barratt ◽  
...  

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258514
Author(s):  
Cho Lee Wong ◽  
Chi Kong Li ◽  
Kai Chow Choi ◽  
Winnie Kwok Wei So ◽  
Jojo Yan Yan Kwok ◽  
...  

Background Anxiety, nausea and vomiting are common side effects suffered by paediatric patients receiving chemotherapy. Emerging evidence supports the efficacy of immersive virtual reality (IVR) on improving anxiety and distress symptoms including nausea and vomiting among this vulnerable group. This trial aims to assess the feasibility and acceptability of IVR for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy. Method and analysis An exploratory trial supplemented by qualitative methods will be conducted. We will recruit 20 paediatric patients who are aged between 6 and 12 years, chemotherapy naïve, scheduled to receive their first intravenous chemotherapy and able to understand Chinese. Participants will be randomly allocated to intervention or control groups. The intervention group will receive the IVR intervention for three sessions as follows: 4 hours before chemotherapy, 5 minutes before and during their first course chemotherapy and 5 minutes before and during their second course chemotherapy. The control group will receive standard care only. Main outcome measures included (1) key parameters for the design of a definitive trial (i.e. screening, eligibility, consent and withdrawal rates); (2) anxiety, anticipatory and acute chemotherapy-induced nausea and vomiting for collection of preliminary data; (3) feasibility and acceptability of the intervention. Semi-structured interviews will be conducted with patients, parents and oncology nurses. Generalized estimating equations model will be used to compare each of the outcome measures across the time points between the two groups. Qualitative data will be analysed by conventional content analysis. Expected results The results of this exploratory trial will inform the design and conduct of future definitive trial. Trial registration number ChiCTR1900021694; Pre-results.


2021 ◽  
Vol 9 (4) ◽  
pp. 12-25
Author(s):  
Maria Cockerill ◽  
Allen Thurston ◽  
Andy Taylor ◽  
Joanne O’Keeffe ◽  
Tien‐Hui Chiang

This article reports results of a phase 2 exploratory trial of a vocabulary program delivered in elementary schools to improve student’s reading ability, including their comprehension. The intervention was tested as a targeted intervention in classrooms with children aged 7–10 across 20 weeks during one school year, with eligible students learning in small groups of four. Teachers and support staff received training in this cooperative learning approach to develop children’s vocabulary with particular focus on Tier‐2 words. School staff received additional support and resources to equip them to develop and implement the vocabulary instruction sessions to targeted students. The trial was undertaken with a sample of 101 students in seven schools from three English district areas with high levels of socio‐economic disadvantage. A standardized reading test was used to measure reading outcomes, with significant gains found in student’s overall reading ability, including comprehension. Owing to the positive results found in this trial, including positive feedback about implementation of the technique, next steps should be a larger trial with 48 schools to avoid the risk of sampling error due to limited number of schools.


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