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Completed

NCT Number: NCT03352817

Study of Sexual Dysfunction in Patients Included in a Cardiac Rehabilitation Program in Champagne-Ardenne

Sexual health is an important marker of individual quality of life and well-being of patients. Sexual dysfunction (SD) is common in patients with heart disease. Screening and management are recommended. Cardiac rehabilitation (CR) seems to be a privileged moment to address this problem, but the management is often insufficient. The main objective of the study was to evaluate the prevalence of SD in patients in CR in the Champagne-Ardenne region. Secondary objectives were to describe SD most frequently encountered, to identify risk factors of SD, to compare the feelings of patients about their sex life, before and after an acute cardiac event and to collect an estimate of the need for care by a dedicated sexology workshop. The investigators conducted an observational multicenter prospective study for descriptive and analytical purposes after approval by the Institutional review board. An anonymous questionnaire was distributed from June 1 to September 1, 2017 in patients participating in a cardiac rehabilitation program in the various centers in the region.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

Reims, 51092, France

About this study

Sexual health is an important marker of individual quality of life and well-being of patients. Sexual dysfunction (SD) is common in patients with heart disease. Screening and management are recommended. Cardiac rehabilitation (CR) seems to be a privileged moment to address this problem, but the management is often insufficient. The main objective of the study was to evaluate the prevalence of SD in patients in CR in the Champagne-Ardenne region. Secondary objectives were to describe SD most frequently encountered, to identify risk factors of SD, to compare the feelings of patients about their sex life, before and after an acute cardiac event and to collect an estimate of the need for care by a dedicated sexology workshop.

This prospective multicentre study was carried out in the cardiac rehabilitation centers of Champagne-Ardenne (Reims, Ardennes and Troyes ) between 1 June and 1 September 2017 by anonymous self-questionnaire.

Eligible patients must have reached the age of majority, participate in a CR program at one of the centers cited, and agreed to respond to the study questionnaire voluntarily. Sexual inactivity and celibacy were not exclusionary criteria because prior sexual behavior did not predict future behavior and the need for counseling. Patients were informed about the objectives and conduct of the study by a health professional during their rehabilitation program or in follow-up consultations with the cardiologist. If the patient agreed to participate in the study, a questionnaire and an information sheet was provided. The questionnaire had to be completed anonymously and individually by the patient, to avoid any influence. It was then put back in an enclosed opaque envelope, in a closed urn left near the cloakroom of each center.

Data are described as mean (± standard deviation) for quantitative variables and as a percentage for categorical variables. The Student or Wilcoxon-Mann Whitney test were used for the quantitative variables and chi-square or Fisher's exact test for categorical variables. The multivariate analysis of SD risk factors was performed by logistic regression. The Odds Ratio (OR) is reported with its 95% confidence interval (CI). The tests were bilateral with a threshold of significance at p <0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients must have reached the age of majority, participate in a CR program at one of the centers cited, and agreed to respond to the study questionnaire voluntarily

Exclusion criteria

  • <18yo

Treatment and study plan

Cardiac rehabilitation

Other

A questionnaire and an information sheet are provided. The questionnaire had to be completed anonymously and individually by the patient, to avoid any influence.

Primary outcomes

  1. Prevalence of sexual dysfunction in cardiac rehabilitation

    Time frame: Day 0

    Specific key measurements or observations used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Study of Sexual Dysfunction and Place of Sexuality in Patients Included in a Cardiac Rehabilitation Program in Champagne-Ardenne

Acronym: SexualDysf

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2017
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.