RCTs - Protocols/Proposals (non-eHealth)

Effect of Live Environmental Music Therapy and Prerecorded Music on State Anxiety, Stress, Pain, and Well-Being Levels of Patients and Caregivers in the Emergency Department Waiting Room: Protocol for a Multicenter Randomized Clinical Trial

Angélica Hernández, Ana María Díaz, Ornella Fiorillo Moreno, Raúl Suárez, Moshé Amarillo, Ana María Moreno, Bryan Alonso Ríos Suarez, Lina Marcela Gómez González, Guiselle Alexandra Cristancho Olaya, Mark Ettenberger

JMIR Res Protoc 2025 (Jun 18); 14:e69131

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Treatment of Erythematotelangiectatic Rosacea With Collateral Puncture Therapy: Protocol for a Randomized Controlled Trial

Aolin Song, Bingnan Cui, Xuemin Wang, Jianing Bi, Xiaohong Wu, Liu Yang, Li Liu, Shengyuan Qu, Zhu Fan, Jiao Yang, Yuhe Yan

JMIR Res Protoc 2025 (Jun 17); 14:e59682

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Effects of Selective Head-and-Neck Cooling on Brain Injury-Related Biomarker Levels and Symptom Rating Following a Boxing Bout: Protocol for an Exploratory Randomized Trial

Ali Al-Husseini, Yelverton Tegner, Kaj Blennow, Henrik Zetterberg, Niklas Marklund

JMIR Res Protoc 2025 (Jun 16); 14:e68954

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Sexual Health Determinants During the Life Course and Migration of Haitian-Origin People in French Guiana: Protocol for the Parcours d’Haïti Biographical and Transdisciplinary Study

Leslie Alcouffe, Marc-Alexandre Tareau, Gabriel Brun Rambaud, Aude Lucarelli, Mathilde Boutrou, Camille Thorey, Greta Cantalupi, Karl Kpossou, Florence Huber, Sébastien Rabier, Dévi Rita Rochemont, Théo Blaise, Estelle Thomas, Guerline Jean, Ruth Pierre Louis, Annette Zephirin, Célia Basurko, Félix Djossou, Hawa Cissé, William Faurous, Quentin Drouaud, Mayka Mergeay-Fabre, Antoine Adenis, Mathieu Nacher, Nicolas Vignier

JMIR Res Protoc 2025 (Jun 12); 14:e63586

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Efficacy and Safety of Haidebao Body Lotion in Patients With Mild Atopic Dermatitis: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Zhen Duan, Yuning Ding, Ruiping Wang

JMIR Res Protoc 2025 (Jun 10); 14:e71255

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Integrated Psychosocial Care in Intensive Care (IPS-Pilot): Protocol for the Systematic, Multimethod Development of a Complex Intervention (Phase A)

Sophie Felicitas Nickel, Simone Korger, Wencke Schindler, Heike Heytens, Gironimo Krieg, Karl-Philipp Drewitz, Katrin Schürmann, Leon Schössow, Julianna Gehrig, Marius Binneböse, Christian Hirning, Klaus Hönig, Rolf Konstantin Niessen, Julia Kirschbaum, Laurence Erdur, Sophie Peter, Florian Junne, Matthias Rose, Christian Apfelbacher, Harald Gündel

JMIR Res Protoc 2025 (Jun 06); 14:e65682

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Effectiveness of a Person-Centered and Culturally Sensitive Course of Treatment in Arabic-, Turkish-, and Urdu-Speaking Individuals With Type 2 Diabetes (the ACCT2 Study): Protocol for a Pragmatic Randomized Controlled Trial

Natasja Bjerre, Lene Christensen, Christina Hoeiberg, Cecilie Ottosson, Mie Klarskov Jensen, Nanna Kildsig, Trine Kjeldgaard Møller, Anne-Ditte Termannsen, Bettina Ewers, Britt Hollender-Schou, Rikke Molin Grue, Ulla Bjerre-Christensen, Solveig Jansen, Kamran Akram

JMIR Res Protoc 2025 (Jun 05); 14:e67319

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Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial

Sandra Ofori, Michael H McGillion, Flavia K Borges, Carley Ouellette, Ameen Patel, David Conen, Maura Marcucci, Michael Ke Wang, Lily Jaeyoung Park, Conor Bell, Jennifer Lounsbury, Kanae Nagatani, Vikas Tandon, Trevor J Wilkieson, Ahraaz Wyne, Valerie Harvey, Stephanie Harrison, Rahima Nenshi, Jessica Bogach, John Harlock, Margherita Cadeddu, Shawn Forbes, Shariq Haider, Reza D Mirza, Sunita Narang, Clare J Reade, Daniel M Tushinski, Amit Raut, Samir Raza, Ted Scott, Anthony Adili, Jeremy Petch, PJ Devereaux

JMIR Res Protoc 2025 (Jun 02); 14:e72672

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The Effects of Acupoint Stimulation Combined With Transcutaneous Electrical Nerve Stimulation on Labor Pain: Protocol for a Stepped Wedge Cluster Randomized Controlled Trial

Yiyun Gu, Xiaojiao Wang, Chunxiang Zhu, Hui Min, Jialu Zhang, Liping Mao, Hua Gao, Hangyun Sun, Xinli Zhu, Chunyi Gu

JMIR Res Protoc 2025 (May 26); 14:e63050

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A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial

Xiaomin Hao, Lili Zhang, Yu Gong, Jun Wang, Weilan Qin, Xudong Zhang, Qiulei Guo, Meng Xu, Taotao Lv, Yan Guo, Yu Liu, Jipeng Liu, Bingnan Yue, Qingguo Liu

JMIR Res Protoc 2025 (May 23); 14:e71850

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Impact of Mānuka Honey on Symptoms and Quality of Life in Individuals With Functional Dyspepsia: Protocol for a Feasibility Randomized Controlled Trial

Laura Ombasa, Jody Miller, Lara Ware, Holly Abbotts-Holmes, Jeffry Tang, Olivier Gasser, Karl Fraser, Simone Bayer, Roslyn Kemp, Rory Costello, Andrew Highton, Jackie Evans, Troy Merry, Michael Schultz, Chris Frampton, Richard Gearry, Warren McNabb, Nicole Roy

JMIR Res Protoc 2025 (May 21); 14:e66417

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Testing an Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults: Protocol for a Randomized Controlled Trial

Nicolas Mascret, Lisa Delbes, Cédric Goulon, Gilles Montagne

JMIR Res Protoc 2025 (May 21); 14:e57866

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The Communities Organizing for Power Through Empathy (COPE) Community-Based Intervention to Improve Adult Mental Health During Disasters and Crises: Protocol for a Stepped-Wedge Cluster Randomized Trial

Jennifer Scott, Tara Powell, Natasha M Lee-Johnson

JMIR Res Protoc 2025 (May 20); 14:e63723

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Water, Sanitation, and Hygiene for Everyone Intervention Study: Protocol for a Controlled Before-and-After Trial

Kondwani Chidziwisano, Mindy Panulo, Clara MacLeod, Marcella Vigneri, Blessings White, Joseph Wells, Ian Ross, Tracy Morse, Robert Dreibelbis

JMIR Res Protoc 2025 (May 15); 14:e68280

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Clinical Efficacy and Safety of the Herbal Prescription, HH333, in Preventing Recurrent Stroke in Patients With Ischemic Stroke Induced by Small-Vessel Disease: Protocol for Multicenter, Double-Blind, Randomized, Prospective, Pilot Clinical Trial

Han-Gyul Lee, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Cheol-Hyun Kim, Dong-Jun Choi

JMIR Res Protoc 2025 (May 13); 14:e70953

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Evaluating the Efficacy and Safety of 48-Week Low-Dose Dienogest Administration in Patients With Dysmenorrhea Caused by Endometriosis: Protocol for a Randomized, Open-Label, Parallel-Group Trial

Kyoko Kikuno, Ryuta Asada, Takuma Ishihara, Yoshimasa Bomoto, Saki Murase, Yoko Ueda, Tomomi Shiga, Yoh Hayasaki, Tatsuro Furui, Satoko Matsuzaki, Masahiko Takemura, Kazutoshi Matsunami, Makoto Kubo, Naoki Ito, Masanori Isobe, Ken-ichirou Morishige

JMIR Res Protoc 2025 (May 13); 14:e66246

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Effect of Early Treatment of Spasticity After Stroke on Motor Recovery: Protocol for the Baclotox Multicenter, Double-Blind, Double-Dummy Randomized Controlled Trial

Emmeline Montane, Nabila Brihmat, Camille Cormier, Claire Thalamas, Vanessa Rousseau, Gerard Tap, Xavier De Boissezon, Evelyne Castel-Lacanal, Baclotox Group, Philippe Marque

JMIR Res Protoc 2025 (May 09); 14:e62951

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Metabolic Flexibility to Predict Lifestyle Interventions Outcomes (MEPHISTO): Protocol for Predictive Validation Study and Randomized Controlled Trial

Monika Ludlova, Kateřina Koudelková, Jitka Pallova, Barbora Koudelkova, Michaela Siklova, Monika Cahova, Tomas Vetrovsky, Michal Steffl, Jan Gojda

JMIR Res Protoc 2025 (May 08); 14:e67570

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Effects of Traditional Chinese Exercise Yijinjing on Disability and Muscle Strength Among Patients With Chronic Low Back Pain: Protocol for a Randomized Controlled Trial

Lei Guo, Cheng Wang, Xue Bai, Yukui Tian, Mengni Shi, Min Fang, Jing Xian Li, Qingguang Zhu, Junchang Liu

JMIR Res Protoc 2025 (May 07); 14:e67557

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Short- and Long-Term Effectiveness of Brief Intensive Trauma Treatment for Adolescents With Posttraumatic Stress Disorder and Their Caregivers: Protocol for a Multicenter Randomized Controlled Trial

Myrna M Westerveld, Malindi van der Mheen, Rik Knipschild, Kim Maijer, Marieke E de Keizer-Altink, Nina Albisser, Marielle J E Hoekstra, Anne Timmermans-Jansen, Rosa Zijp, Anne A Krabbendam, Francisca J A (Bonny) van Steensel, Kees-Jan Kan, Chaim Huyser, Wouter G Staal, Elisabeth M W J Utens, Ramón J L Lindauer

JMIR Res Protoc 2025 (Apr 30); 14:e66115

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