Clinical trial NCT03615586: The Use of Chaperone in Routine Anorectal Examination
Official title: The Use of Chaperone in Routine First Visit Anorectal Examination of Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exanimation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background and aim: The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. The aim of this study is to compare the patients' perception and preference regarding the presence of a chaperone during their first anorectal examination. Patients and methods: adult women will be randomly selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present in that clinical situation. The patients will prospectively enrolled in one of the two groups of this randomized trial during a period of two years.

Detailed description: The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. However, there are some guidance saying says that doctors should offer the patient the option of a chaperone wherever possible before conducting an intimate examination. The aim of this study is to compare the female patients' perception and preference regarding the presence of a chaperone during their first anorectal examination conduct by a male physician. Adult women will be investigated during their first visit to a Coloproctology Clinic at University Hospital. Only senior professionals will be examining the patients. This will be a prospectively randomized trial. Patients will be selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present during the anorectal examination. The enrollment period will be two years from July 2018. Sample size estimated for the study is 188 patients (94 in each study group).

Eligibility criteria: Inclusion Criteria:

* adult female patients;
* first visit to our Coloproctology clinic;
* signed consent form

Exclusion Criteria:

* patients previously submitted to anorectal examination;
* refusal of participation.

Primary outcomes:
measure: Preference to have or not chaperone during anorectal examination.
timeFrame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary outcomes:
measure: Degree of comfort during anorectal examination.
timeFrame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
measure: Patients's feeling about having or not chaperone during anorectal examination.
timeFrame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
measure: Evaluation of the anorectal examination according to the presence or absence of a chaperone
timeFrame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
measure: Feeling of protection during anorectal examination according to the presence or absence of a chaperone
timeFrame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
measure: Preference to have a chaperone in a future anorectal examination
timeFrame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Daniel C Damin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. doi: 10.1056/NEJMp058120. No abstract available.
citation: Stagno SJ, Forster H, Belinson J. Medical and osteopathic boards' positions on chaperones during gynecologic examinations. Obstet Gynecol. 1999 Sep;94(3):352-4. doi: 10.1016/s0029-7844(99)00301-4.
citation: Ehrenthal DB, Farber NJ, Collier VU, Aboff BM. Chaperone use by residents during pelvic, breast, testicular, and rectal exams. J Gen Intern Med. 2000 Aug;15(8):573-6. doi: 10.1046/j.1525-1497.2000.10006.x.
citation: Conway S, Harvey I. Use and offering of chaperones by general practitioners: postal questionnaire survey in Norfolk. BMJ. 2005 Jan 29;330(7485):235-6. doi: 10.1136/bmj.38320.472986.8F. Epub 2004 Dec 16. No abstract available.
citation: Whitford DL, Karim M, Thompson G. Attitudes of patients towards the use of chaperones in primary care. Br J Gen Pract. 2001 May;51(466):381-3.
citation: Teague R, Newton D, Fairley CK, Hocking J, Pitts M, Bradshaw C, Chen M. The differing views of male and female patients toward chaperones for genital examinations in a sexual health setting. Sex Transm Dis. 2007 Dec;34(12):1004-7. doi: 10.1097/OLQ.0b013e3180ca8f3a.