The Use of Chaperone in Routine Anorectal Examination

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Exanimation

Intervention / Treatment
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* Other: With Chaperone
* Other: Without Chaperone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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). |