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

Abstract

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 reação das mulheres após lerem o Termo de Consentimento Livre e Esclarecido (TCLE) antes de se submeterem a cirurgias ginecológicas/uroginecológicas eletivas.

Métodos Um estudo qualitativo com 53 mulheres foi realizado entre setembro de 2014 e maio de 2015. A análise do conteúdo foi feita depois de uma entrevista que seguia um roteiro, que foi realizada em uma sala reservada e transcrita de forma fidedigna. Nós lemos de novo o TCLE na frente da paciente, e depois ela era entrevistada de acordo com um roteiro de questões sobre emoções e reações que ocorreram sobre o procedimento e suas expectativas sobre o período intra e pós-operatório.

Resultados As mulheres tinham uma média de 52 anos, eram multíparas, e com poucos anos de educação (54,7%). A maioria (60,4%) já havia realizado cirurgias uroginecológicas. A histerectomia e a colpoperineoplastia foram as cirurgias mais frequentes. Dez mulheres não 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 indiferença (30,8%) e da resignação (13,5%). Nove mulheres consideraram suas reações inesperadas depois da leitura do TCLE. Três pacientes não consideraram a informação do TCLE suficiente, e outras 3 tiveram dúvidas sobre a cirurgia depois de lerem o documento.

Conclusão A leitura do TCLE desperta o medo na maioria das mulheres; contudo, elas acreditam que este sentimento não interferiu na tomada de decisão relativa ao tratamento.

Keywords

qualitative study - informed consent - decision-making process - elective surgical procedures

Palavras-chave

estudo qualitativo - consentimento livre e esclarecido - tomada de decisões - procedimentos cirúrgicos eletivos

Contributions

Amorim AC, Santos LGT, Poli-Neto OB and Brito LGO contributed with project and interpretation of data, writing of the article, critical review of the intellectual content and final approval of the version to be published.

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