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1.
Trials ; 24(1): 759, 2023 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-38012776

RESUMO

BACKGROUND: Endometriosis is a chronic disease characterized by growth of endometrial tissue outside the uterine cavity which could affect 200 million women (The term "woman" is used for convenience. Individuals gendered as man or as nonbinary can also suffer from this disease) worldwide. One of the most common symptoms of endometriosis is pelvic chronic pain associated with fatigue. This pain can cause psychological distress and interpersonal difficulties. As for several chronic diseases, adapted physical activity could help to manage the physical and psychological symptoms. The present study will investigate the effects of a videoconference-based adapted physical activity combined with endometriosis-based education program on quality of life, pain, fatigue, and other psychological symptoms and on physical activity. METHODS: This multicentric randomized-controlled trial will propose to 200 patients with endometriosis to be part of a trial which includes a 6-month program with 45 min to more than 120 min a week of adapted physical activity and/or 12 sessions of endometriosis-based education program. Effects of the program will be compared to a control group in which patients will be placed on a waiting list. All participants will be followed up 3 and 6 months after the intervention. None of the participants will be blind to the allocated trial arm. The primary outcome measure will be quality of life. Secondary outcomes will include endometriosis-related perceived pain, fatigue, physical activity, and also self-image, stereotypes, motivational variables, perceived support, kinesiophobia, basic psychological need related to physical activity, and physical activity barriers. General linear models and multilevel models will be performed. Predictor, moderator, and mediator variables will be investigated. DISCUSSION: This study is one of the first trials to test the effects of a combined adapted physical activity and education program for improving endometriosis symptoms and physical activity. The results will help to improve care for patients with endometriosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05831735 . Date of registration: April 25, 2023.


Assuntos
Endometriose , Qualidade de Vida , Masculino , Humanos , Feminino , Endometriose/diagnóstico , Endometriose/terapia , Endometriose/complicações , Exercício Físico , Dor Pélvica/etiologia , Fadiga , Comunicação por Videoconferência , Terapia por Exercício/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
Am J Obstet Gynecol ; 207(5): 388.e1-6, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22939402

RESUMO

OBJECTIVE: To investigate the efficacy, safety, removal characteristics, and x-ray visibility of Nexplanon, a radiopaque etonogestrel contraceptive implant combined with a next-generation applicator. STUDY DESIGN: A 3-year, nocomparative, multicenter study in women aged 18-40 years at 23 clinical sites. RESULTS: Of 301 women who had an implant inserted, none became pregnant while the implant was in situ. Serious adverse events were reported in 16 of 301 (5.3%) women; none were judged as drug related. Fibrosis around the implant was the most common removal complication (4.4%). The implant was visible on X-ray and palpable before removal with a mean removal time of 2 minutes. CONCLUSION: Nexplanon showed high contraceptive efficacy, palpability before removal, short removal times, and few removal complications. Nexplanon provides clinicians with a long-term hormonal contraceptive method with a safety and efficacy profile comparable to Implanon, radiopacity, and a new applicator.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Desogestrel/administração & dosagem , Bombas de Infusão Implantáveis/efeitos adversos , Administração Intravaginal , Adolescente , Adulto , Anticoncepcionais Femininos/efeitos adversos , Meios de Contraste/administração & dosagem , Meios de Contraste/efeitos adversos , Desogestrel/efeitos adversos , Feminino , Fibrose , Humanos , Útero/efeitos dos fármacos , Útero/patologia , Adulto Jovem
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