How Does the Patient React After Reading the Informed Consent Form of a Gynecological Surgery? A Qualitative Study

Objective To analyze the reaction of women after reading the Informed Consent Form (ICF) before undergoing elective gynecological/urogynecological surgeries. Methods A qualitative study with 53 women was conducted between September 2014 and May 2015. The analysis of the content was conducted after a scripted interview was made in a reserved room and transcribed verbatim. We read the ICF once more in front of the patient, and then she was interviewed according to a script of questions about emotions and reactions that occurred about the procedure and her expectations about the intra- and postoperative period. Results The women had a mean age of 52 years, they were multiparous, and most had only a few years of schooling (54.7%). The majority (60.4%) of them had undergone urogynecological surgeries. Hysterectomy and colpoperineoplasty were the most frequent procedures. Ten women had not undergone any previous abdominal surgery. Fear (34.6%) was the feeling that emerged most frequently from the interviews after reading the ICF, followed by indifference (30.8%) and resignation (13.5%). Nine women considered their reaction unexpected after reading the ICF. Three patients did not consider the information contained in the ICF to be sufficient, and 3 had questions about the surgery after reading the document. Conclusion Reading the ICF generates fear in most women; however, they believe this feeling did not interfere in their decision-making process. Resumo Objetivo Analisar a reacAo das mulheres apos lerem o Termo de Consentimento Livre e Esclarecido (TCLE) antes de se submeterem a cirurgias ginecologicas/uroginecologicas eletivas. Metodos Um estudo qualitativo com 53 mulheres foi realizado entre setembro de 2014 e maio de 2015. A analise do conteudo foi feita depois de uma entrevista que seguia um roteiro, que foi realizada em uma sala reservada e transcrita de forma fidedigna. Nos lemos de novo o TCLE na frente da paciente, e depois ela era entrevistada de acordo com um roteiro de questoes sobre emocoes e reacoes que ocorreram sobre o procedimento e suas expectativas sobre o periodo intra e pos-operatorio. Resultados As mulheres tinham uma media de 52 anos, eram multiparas, e com poucos anos de educacAo (54,7%). A maioria (60,4%) ja havia realizado cirurgias uroginecologicas. A histerectomia e a colpoperineoplastia foram as cirurgias mais frequentes. Dez mulheres nAo tinham sido submetidas a nenhum procedimento. O medo (34,6%) foi o sentimento que mais emergiu das entrevistas depois da leitura do TCLE, seguido da indiferenca (30,8%) e da resignacAo (13,5%). Nove mulheres consideraram suas reacoes inesperadas depois da leitura do TCLE. Tres pacientes nAo consideraram a informacAo do TCLE suficiente, e outras 3 tiveram duvidas sobre a cirurgia depois de lerem o documento. ConclusAo A leitura do TCLE desperta o medo na maioria das mulheres; contudo, elas acreditam que este sentimento nAo interferiu na tomada de decisAo relativa ao tratamento.