The Use of Chaperone in Routine Anorectal Examination

NCT03615586 | Unknown

• 1 other identifier: 17-0597
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Exanimation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Degree of comfort during anorectal examination.

  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.

  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

  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

  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

  Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).

Study Arms (2)

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.

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.

Other: Without Chaperone

Interventions

With Chaperone OTHER

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

With Chaperone

Without Chaperone OTHER

Female patients examined by male physicians without the presence of a female (nurse) chaperone.

Without Chaperone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Only female patients can be eligible for the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female patients;
• first visit to our Coloproctology clinic;
• signed consent form

You may not qualify if:

• patients previously submitted to anorectal examination;
• refusal of participation.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil

RECRUITING

Related Publications (7)

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

  PMID: 16107618 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.

  PMID: 10472858 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.

  PMID: 10940150 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.

  PMID: 15604154 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.

  PMID: 11360703 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.

  PMID: 17621250 BACKGROUND

• 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.

  PMID: 39745520 DERIVED

MeSH Terms

Conditions

Coma

Interventions

Molecular Chaperones

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Daniel C Damin, MD, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 6, 2018
• Study Start: July 26, 2018
• Primary Completion: July 26, 2020
• Study Completion: July 27, 2020
• Last Updated: August 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)