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The Use of Chaperone in Routine Anorectal Examination

Primary Purpose

Exanimation

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
With Chaperone
Without Chaperone
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Exanimation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

With Chaperone

Without Chaperone

Arm Description

Female patients examined by male physicians in the presence of a female (nurse) chaperone. The intervention consists of the presence of a female chaperone.

Female patients examined by male physicians without a chaperone. The intervention is the absence of a female chaperone.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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.
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.
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.

Full Information

First Posted
July 30, 2018
Last Updated
August 8, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03615586
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
July 26, 2020 (Anticipated)
Study Completion Date
July 27, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exanimation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With Chaperone
Arm Type
Active Comparator
Arm Description
Female patients examined by male physicians in the presence of a female (nurse) chaperone. The intervention consists of the presence of a female chaperone.
Arm Title
Without Chaperone
Arm Type
Active Comparator
Arm Description
Female patients examined by male physicians without a chaperone. The intervention is the absence of a female chaperone.
Intervention Type
Other
Intervention Name(s)
With Chaperone
Intervention Description
Female patients examined by male physicians in the presence of a female (nurse) chaperone.
Intervention Type
Other
Intervention Name(s)
Without Chaperone
Intervention Description
Female patients examined by male physicians without the presence of a female (nurse) chaperone.
Primary Outcome Measure Information:
Title
Preference to have or not chaperone during anorectal examination.
Description
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.
Time Frame
Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary Outcome Measure Information:
Title
Degree of comfort during anorectal examination.
Description
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)
Time Frame
Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Title
Patients's feeling about having or not chaperone during anorectal examination.
Description
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.
Time Frame
Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Title
Evaluation of the anorectal examination according to the presence or absence of a chaperone
Description
Question: "Do you think the (absence) presence of another person made the examination" . There are 3 possible answers: better, worse, did not change it.
Time Frame
Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Title
Feeling of protection during anorectal examination according to the presence or absence of a chaperone
Description
Question: "Did you feel more (less) protected with (without) the presence of another person?" There are 3 possible answers: yes, no, indifferent.
Time Frame
Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Title
Preference to have a chaperone in a future anorectal examination
Description
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.
Time Frame
Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female patients can be eligible for the study
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel C Damin, MD, PhD
Phone
55-51-996020442
Email
damin@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo C Contu, MD
Phone
55-51-99987-5051
Email
contu@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Damin, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90.035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel C Damin
Phone
5551996020442
Ext
5551996020442
Email
damin@terra.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16107618
Citation
Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. doi: 10.1056/NEJMp058120. No abstract available.
Results Reference
background
PubMed Identifier
10472858
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.
Results Reference
background
PubMed Identifier
10940150
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.
Results Reference
background
PubMed Identifier
15604154
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.
Results Reference
background
PubMed Identifier
11360703
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.
Results Reference
background
PubMed Identifier
17621250
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.
Results Reference
background

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The Use of Chaperone in Routine Anorectal Examination

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