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Randomized Controlled Trial
The effect of the therapy of "combination 3 methods progression" in patients with neurogenic bowel dysfunction (constipated type): Study protocol for a randomized controlled trial.
- Qing Li, Yin-Li Shen, Yun-Lan Jiang, Dong-Shuang Li, and Song Jin.
- Nursing School, Chengdu University of Traditional Chinese Medicine.
- Medicine (Baltimore). 2021 Feb 19; 100 (7): e24662e24662.
BackgroundAs one of the important manifestations of neurogenic bowel dysfunction, constipation is characterized by high incidence and harmful effects. It has a negative impact on both physical and psychological health of patients. And there are no effective treatment options for this type of disease clinically. Therefore, this study is designed to examine the effect of the therapy of "combination 3 methods progression" in patients with neurogenic bowel dysfunction (constipated type).MethodsThis is a randomized, controlled, parallel-design clinical trial. A total of 60 patients with neurogenic bowel dysfunction (constipated type) will be randomly assigned to intervention group and control group. The control group will receive 4 weeks of usual rehabilitation care, the intervention group will receive 4 weeks of the therapy of "combination 3 methods progression" in addition to usual rehabilitation care. The primary outcome is the number of spontaneous bowel movement per week. Secondary outcomes are stool characteristics, degree of difficulty in defecation, level of anxiety, level of depression, and level of self-efficacy.DiscussionThe interventions of this protocol have been programmed to alleviate constipation in patients with neurogenic bowel dysfunction. Findings may provide preliminary evidence for clinical efficacy of the therapy of "combination 3 methods progression."Trial RegistrationChinese Clinical Trial Registry, IDF: ChiCTR2000041463. Registered on December 26, 2020.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
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