The Use of Chaperone in Routine Anorectal Examination

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

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.

Study Overview

• Status: Unknown
• Conditions: Exanimation
• Intervention / Treatment: Other: With Chaperone; Other: Without Chaperone

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).

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90.035-903
      • Recruiting
      • Hospital De Clinicas De Porto Alegre
      • Contact: Daniel C Damin; Phone Number: 5551996020442 5551996020442; Email: damin@terra.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With Chaperone; Female patients examined by male physicians in the presence of a female (nurse) chaperone. The intervention consists of the presence of a female chaperone.	Other: With Chaperone; Female patients examined by male physicians in the presence of a female (nurse) chaperone.
Active Comparator: Without Chaperone; Female patients examined by male physicians without a chaperone. The intervention is the absence of a female chaperone.	Other: Without Chaperone; Female patients examined by male physicians without the presence of a female (nurse) chaperone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Daniel C Damin, MD, PhD, Hospital De Clinicas De Porto Alegre

Publications and helpful links

General Publications

• Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. doi: 10.1056/NEJMp058120. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Anticipated): July 26, 2020
• Study Completion (Anticipated): July 27, 2020

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma
• Other Study ID Numbers: 17-0597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No