ExanimationNCT03615586
The Use of Chaperone in Routine Anorectal Examination
A study testing With Chaperone and Without Chaperone in people with Exanimation, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Exanimation
- What is being tested?
- With Chaperone and Without Chaperone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jul 2018to 27 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult female patients;
- first visit to our Coloproctology clinic;
- signed consent form
Who cannot join
- patients previously submitted to anorectal examination;
- refusal of participation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903
Daniel C Damin, 5551996020442 ext. 5551996020442, damin@terra.com.br
About this study
Official title: 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.
Read the 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).
- Conditions
- Exanimation
- Being tested
- With Chaperone, Without Chaperone
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With ChaperoneOther
Female patients examined by male physicians in the presence of a female (nurse) chaperone.
Without ChaperoneOther
Female patients examined by male physicians without the presence of a female (nurse) chaperone.
| Study group | Role | What they receive |
|---|---|---|
| With Chaperone | Active comparator | Female patients examined by male physicians in the presence of a female (nurse) chaperone. The intervention consists of the presence of a female chaperone. Receives: Other: With Chaperone |
| Without Chaperone | Active comparator | Female patients examined by male physicians without a chaperone. The intervention is the absence of a female chaperone. Receives: Other: Without Chaperone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Secondary outcomes (5)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start26 Jul 2018
- Primary completion26 Jul 2020 (estimated)
- Study completion27 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ExanimationStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel C Damin, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615586
- Sponsor's protocol ID
- 17-0597
- Status last verified
- Jul 2018
- First submitted
- 30 Jul 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. doi: 10.1056/NEJMp058120. No abstract available.
PubMed 16107618Stagno 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.
PubMed 10472858Ehrenthal 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.
PubMed 10940150Conway 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.
PubMed 15604154Whitford 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.
PubMed 11360703Teague 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.
PubMed 17621250Damin DC, Contu PC, Savaris RF, Biazi B. Women's preferences regarding the use of chaperones during proctological examinations conducted by male physicians: a randomised clinical trial. Int J Colorectal Dis. 2025 Jan 2;40(1):3. doi: 10.1007/s00384-024-04796-4.
PubMed 39745520
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Chaperone in Routine First Visit Anorectal Examination of Women
- ClinicalTrials.gov ID
- NCT03615586
- Acronym / sponsor ID
- 17-0597
- Conditions
- Exanimation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 26 Jul 2020 (estimated)
- Study completion
- 27 Jul 2020 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Chaperone | Active comparator | Other: With ChaperoneFemale patients examined by male physicians in the presence of a female (nurse) chaperone. The intervention consists of the presence of a female chaperone. |
| Without Chaperone | Active comparator | Other: Without ChaperoneFemale patients examined by male physicians without a chaperone. The intervention is the absence of a female chaperone. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult female patients;
- first visit to our Coloproctology clinic;
- signed consent form
Key exclusion criteria (2 listed)
- patients previously submitted to anorectal examination;
- refusal of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With ChaperoneFemale patients examined by male physicians in the presence of a female (nurse) chaperone. | Other | With Chaperone |
| Without ChaperoneFemale patients examined by male physicians without the presence of a female (nurse) chaperone. | Other | Without Chaperone |
Primary outcome
Preference to have or not chaperone during anorectal examination.
Time frame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
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.
5 secondary outcomes
Degree of comfort during anorectal examination.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Background: PubMed 16107618Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. doi: 10.1056/NEJMp058120. No abstract available.
- Background: PubMed 10472858Stagno 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.
- Background: PubMed 10940150Ehrenthal 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.
- Background: PubMed 15604154Conway 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.
- Background: PubMed 11360703Whitford 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.
- Background: PubMed 17621250Teague 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.
- Derived from this study: PubMed 39745520Damin DC, Contu PC, Savaris RF, Biazi B. Women's preferences regarding the use of chaperones during proctological examinations conducted by male physicians: a randomised clinical trial. Int J Colorectal Dis. 2025 Jan 2;40(1):3. doi: 10.1007/s00384-024-04796-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C Damin, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With Chaperone and Without Chaperone in people with Exanimation, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel C Damin, MD, PhD (55-51-996020442, damin@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference to have or not chaperone during anorectal examination. (time frame: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615586, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.