The Use of Chaperone in Routine Anorectal Examination

Exanimation Clinical Trial

Official title:

The Use of Chaperone in Routine First Visit Anorectal Examination of Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615586
• Other study ID #: 17-0597
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: July 27, 2020

Study information

• Verified date: July 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Daniel C Damin, MD, PhD
• Phone: 55-51-996020442
• Email: damin[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: July 27, 2020
• Est. primary completion date: July 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exanimation

Intervention

Other:
• With Chaperone
Female patients examined by male physicians in the presence of a female (nurse) chaperone.
• Without Chaperone
Female patients examined by male physicians without the presence of a female (nurse) chaperone.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. Epub 2004 Dec 16. — View 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. — View Citation

Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference to have or not chaperone during anorectal examination.	Assessed by the question: "Would you rather have taken the exam in the (without) presence of another person (woman)?". There are 3 possible answers: yes, no, indifferent.	Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary	Degree of comfort during anorectal examination.	Assessed by a specific question: "How did you feel during the exam?" Patients will register their answer in a scale from zero (completely embarrassed) to 10 (completely confortable)	Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary	Patients's feeling about having or not chaperone during anorectal examination.	Assessed by the question: "What did you think of (not) having a person besides the doctor during the exam?" Patients will have 3 possible answers: bad, indifferent, good.	Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary	Evaluation of the anorectal examination according to the presence or absence of a chaperone	Question: "Do you think the (absence) presence of another person made the examination" . There are 3 possible answers: better, worse, did not change it.	Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary	Feeling of protection during anorectal examination according to the presence or absence of a chaperone	Question: "Did you feel more (less) protected with (without) the presence of another person?" There are 3 possible answers: yes, no, indifferent.	Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary	Preference to have a chaperone in a future anorectal examination	Question: "In the event of a reexamination, would you want another person's presence again?" There are 3 possible answers: yes, no, indifferent.; Or: "Would you again like the doctor to examine you without another person's presence?" There are 3 possible answers: yes, no, indifferent.	Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).