The purpose of this study is to evaluate patients consulting gastroenterologists regarding their perspectives concerning delicate matters such as sexuality. Would it be helpful if the doctor brings up the subject of SA? And how many patients would…
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be the survey results.
Secondary outcome
We will provide for a standardized questionnaire for new patients consuling a
gastroenterologist and make referral to a sexuologist or psychologist easier.
If proven necessary we will provide a list with sexologist and urologist in the
area, this can make referral easier.
Background summary
Dysfunction of the pelvic floor may lead to a wide range of symptoms, involving
the urinary and gastrointestinal tract as well as sexual function. Only a small
minority of the patients visiting a pelvic floor-clinic has just one symptom.
There is a strong relationship between pelvic floor dysfunction and a history
of SA. In the population consulting a gastroenterologist, the prevalence of SA
history is much higher than in the general population (30-56%). The association
between SA and GI-symptoms relates to a raised tonus of the pelvic floor
muscles, an altered stress-induced mucosal immune function and impaired ability
of the central nervous system to down-regulate incoming visceral and somatic
afferent signals. Patients who (had to) deal with SA have a much poorer health
status, they are more likely to report other symptoms such as depressive
symptoms and fatigue, and they have a high risk of developing Irritable Bowel
Syndrome (IBS).
In the majority of cases, patients consulting a specialist do not mention
complaints in other areas of their body if they are not specifically asked
about them. Understanding the importance of doctors* inquiry about symptoms
relating to their own area of expertise, we recently evaluated whether Dutch
gastroenterologists address pelvic floor related symptoms in their daily
practices. Furthermore we studied the awareness among Dutch gastroenterologists
concerning SA. The results showed that most GE doctors are aware of the
associated symptoms; the majority inquires about micturition and sexual
function in patient presenting with complaints such as constipation and chronic
abdominal pain. Sixty-eight percent of the GE-doctors ask about SA if a female
patient presents with specific complaints. Nevertheless, only 36% of the
doctors think about it when a male patient presents with specific symptoms such
as fecal incontinence.
It is known that performing invasive physical examination, such as colonoscopy,
can provoke intense emotional responses, dissociation or refusal to endure the
procedure. This can be manifested by a startle response to touching,
unanticipated tearfulness before or during the procedure, or cognitive or
emotional dissociation. However, almost none of the GE-doctors ask about SA
before performing a colonoscopy, only 0.6% in male patients and 2.4% in
females.
Study objective
The purpose of this study is to evaluate patients consulting
gastroenterologists regarding their perspectives concerning delicate matters
such as sexuality. Would it be helpful if the doctor brings up the subject of
SA? And how many patients would wish to be referred to a sexologist or a
physiotherapist? Furthermore, how do patient are like to be treated prior and
during endoscopic procedures? We are interested in patient*s perspectives on
the treatment received by their gastroenterologists concerning pelvic floor
complaints and sexual abuse inquiry.
Study design
Study design:
We will perform an anonymous, cross-sectional survey study and include all
patients that underwent a colonoscopy in the HAGA teaching hospital in the past
12 month. Inclusion criteria will be: Age above 18 years old and the ability to
fill out a 34-item questionnaire in the Dutch or English (Appendix) language.
Exclusion criteria: Age beneath 18 years old, legally incapability and/or the
inability to understand and fill out a Dutch or English questionnaire. There
will be no maximum age limit for inclusion in this survey, as many elderly
people tend to consider sexuality an important aspect of life.
Before sending the questionnaires, a letter explaining the objectives of the
study and a consentform will be sent. Patients that are willing to participate
have to return the consentform and state their willingness to participate, a
questionnaire will be send or emailed to those patients in return (as well as a
prepaid return envelope). For patients unwilling to participate, we will
provide an option in the consentform in which they can state their
unwillingness to participate. If this option is marked, we will not approach
the patient again. Non-responders will receive a reminder letter and a
consentform one more time after a month. Data will be handled anonymously; the
main researcher will not be in the possession of the names and addresses
corresponding with the respondents.
This study will be perfomed accordingly in the Zuwe Hofpoort Hospital and in
the Leiden University Medical Center. Ethical approval will be obtained.
Materials; Questionnaire:
In the 34-item questionnaire (Appendix) the different domains of the pelvic
floor will be evaluated. Furthermore it will address the beliefs and overall
impression of patients that visited the gastroenterologist, regarding their
treatment and their experience with colonoscopy.
Demographic data will include gender, age, country of origin and the reason for
consulting the gastroenterologist. Many of the questions are from The Pelvic
Floor Inventories Leiden (PelFI*s), which is validated in both Dutch and
English. A small pilot study among 5 to10 non-medical volunteers will be
performed to investigate whether the questionnaire is comprehensive and easy to
fill in.
Data management:
All data will be collected anonymously. Each consentform will get a number, by
means of which a second letter can be send out in case of unresponsiveness and
the respondents that stated not willing to participate can be removed from of
the mailing list. The data will be analyzed anonymously and the questionnaires
will be stored safely. The main researcher will not be in the possession of the
names and addresses corresponding with the respondents.
Statistical analysis:
Data analysis will be performed using SPSS release 17. Bivariate associations
between demographic information and the type of answers will be calculated
using the Pearson*s chi-square procedure. A two-sided P value of < 0.05 will be
considered statistically significant. Questions with more than one possible
answer and with open answers will be grouped together for analysis.
Ethics:
Because of the personal character of the questions, ethical approval will be
required. We will ask the Medical Ethical Committee for advice.
We will give the respondents with a history of SA the opportunity for referral
to the physician-sexologist (M.P.) at the HAGA teaching hospital or to a
psychologist, because the questionnaire may provoke emotional distress. This
referral will be realized by providing a letter for the General Practitioner;
this letter will explain the reason for the referral and the General
Practitioner just has to sign it in order to arrange a referral to a sexologist
or a psychologist.
Study burden and risks
The questionnaire may provoke emotional distress.
We will give the respondents with a history of SA the opportunity for referral
to the physician-sexuologist (M.P.) at the HAGA Teaching Hospital.
Participation in the study will contribute to the better healthcare towards
invasive procedures such as colonoscopy and towards holistic patientcare.
albinusdreef 2
2333 ZA, Leiden
NL
albinusdreef 2
2333 ZA, Leiden
NL
Listed location countries
Age
Inclusion criteria
Age>18 years old with the capability to understand and fill in a dutch, english or turkish questionnaire.
Patients that underwent a colonoscopy at the HAGA medical centre the Hague in the past 12 month.
Exclusion criteria
-Age under 18 years old.
-legaly incapable people
-mentaly disabled people (IQ<70), including people suffering from dementia.
-unable to master the dutch, english or turkish language.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
---|---|
CCMO | NL38471.098.11 |