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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03615586
Other study ID # 17-0597
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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).
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