Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Without Chaperone | Active Comparator | Female patients examined by male physicians without a chaperone. The intervention is the absence of a female chaperone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With Chaperone | Other | Female patients examined by male physicians in the presence of a female (nurse) chaperone. |
|
| 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). |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Only female patients can be eligible for the study
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel C Damin, MD, PhD | Contact | 55-51-996020442 | damin@terra.com.br | |
| Paulo C Contu, MD | Contact | 55-51-99987-5051 | contu@terra.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Daniel C Damin, MD, PhD | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90.035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16107618 | Background | Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. doi: 10.1056/NEJMp058120. No abstract available. | |
| 10472858 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2018 | Aug 6, 2018 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003128 | Coma |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D018832 | Molecular Chaperones |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Without Chaperone | Other | Female patients examined by male physicians without the presence of a female (nurse) chaperone. |
|
| 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). |
| 10940150 | Background | 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. |
| 15604154 | Background | 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. |
| 11360703 | Background | 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. |
| 17621250 | Background | 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. |
| 39745520 | Derived | Damin 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. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |