Gender RoleNCT03546114
Does Gender Matter? Patient Preference in an Italian Osteopathic Clinical Setting
An observational study of Gender Role, run by Istituto Superiore di Osteopatia di Milano at 1 site in Italy.
Trial summary
This study evaluates patients preference for the gender of their osteopath. All patients referring to an Italian private osteopathic clinic will receive a proper questionnaire before knowing the gender of their designed osteopath. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender Role
- What is being tested?
- Gender Questionnaire
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 15 Feb 2019
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients referring to Centro di Medicina Osteopatica for the first visit.
Inclusion Criteria: first visit at the osteopathic clinic (Centro di Medicina Osteopatica) Milan
Exclusion Criteria: non-Italian speaking
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates patients preference for the gender of their osteopath. All patients referring to an Italian private osteopathic clinic will receive a proper questionnaire before knowing the gender of their designed osteopath.
Read the detailed description
Several previous studies have shown that clinical contextual factors, such as patients preferences, play an important role in the patient-physical relationship, with resulting consequences on clinical outcomes.
The interaction between the gender of both patient and physician is often impacted by existing stereotypes.
Patient preference for specific physician gender has been investigated in scientific literature.
However the are no studies that analyzed the role of gender in osteopathic medicine.
- Conditions
- Gender Role
- Being tested
- Gender Questionnaire
- Keywords
- Gender, Sex and gender, Patient preference, Osteopathic medicine
- Medical subject headings
- Coitus, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gender QuestionnaireOther
13-items questionnaire including demographics questions (gender, age, education; naive to osteopathic treatment or not; general gender preferences; specific gender preference in case of low back pain, neck pain, gastrointestinal disorders, musculoskeletal disorders of upper and lower limbs pain; headache; urogenital disorders
| Study group | Role | What they receive |
|---|---|---|
| Patients referring to an osteopathic clinic - CMO, Milan | Adults, age>18 years, first visit at osteopathic clinic (Centro di Medicina Osteopatica) Receives: Other: Gender Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender questionnaire (Self-reported 13-items questionnaire)
- Patient's gender?
- Patient's age?
- Educational level? (middle school, high school, BSc, MSc, PhD)
- Naive to osteopathic treatment? (yes/no)
- Only if the answer of question 5 is yes, which was the osteopath's gender at your first osteopathic consultation?
- Which would be your favorite osteopath's gender?
- Which would be your favorite osteopath's gender if you had low back pain?
- Which would be your favorite osteopath's gender if you had neck pain?
- Which would be your favorite osteopath's gender if you had gastrointestinal disorders?
- Which would be your favorite osteopath's gender if you had upper limb pain?
- Which would be your favorite osteopath's gender if you had lower limb pain?
- Which would be your favorite osteopath's gender if you had headache?
- Which would be your favorite osteopath's gender if you had urogenital disorders? Questions 7-13: Choose among: female, male, no preference
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Apr 2018
- Primary completion1 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Gender RoleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Superiore di Osteopatia di Milano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Pisa, Istituto Superiore di Osteopatia di Milano
- Investigators
- Silvia Ratti, MSc, Principal investigator, Istituto Superiore di Osteopatia (ISO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546114
- Sponsor's protocol ID
- 052018
- Status last verified
- Aug 2019
- First submitted
- 21 May 2018
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Abghari MS, Takemoto R, Sadiq A, Karia R, Phillips D, Egol KA. Patient perceptions and preferences when choosing an orthopaedic surgeon. Iowa Orthop J. 2014;34:204-8.
PubMed 25328483Alvarez Bustins G, Lopez Plaza PV, Carvajal SR. Profile of osteopathic practice in Spain: results from a standardized data collection study. BMC Complement Altern Med. 2018 Apr 11;18(1):129. doi: 10.1186/s12906-018-2190-0.
PubMed 29642901Amir H, Beri A, Yechiely R, Amir Levy Y, Shimonov M, Groutz A. Do Urology Male Patients Prefer Same-Gender Urologist? Am J Mens Health. 2018 Sep;12(5):1379-1383. doi: 10.1177/1557988316650886. Epub 2016 May 24.
PubMed 27222116Amodio DM. The neuroscience of prejudice and stereotyping. Nat Rev Neurosci. 2014 Oct;15(10):670-82. doi: 10.1038/nrn3800. Epub 2014 Sep 4.
PubMed 25186236Balayla J. Male physicians treating Female patients: Issues, Controversies and Gynecology. Mcgill J Med. 2011 Jun;13(1):72. No abstract available.
PubMed 22399872Bishop FL, Massey Y, Yardley L, Lewith GT. How patients choose acupuncturists: a mixed-methods project. J Altern Complement Med. 2011 Jan;17(1):19-25. doi: 10.1089/acm.2010.0061. Epub 2011 Jan 16.
PubMed 21235412Bishop FL, Bradbury K, Hj Jeludin NN, Massey Y, Lewith GT. How patients choose osteopaths: a mixed methods study. Complement Ther Med. 2013 Feb;21(1):50-7. doi: 10.1016/j.ctim.2012.10.003. Epub 2012 Nov 15.
PubMed 23374205Blanch-Hartigan D, Hall JA, Roter DL, Frankel RM. Gender bias in patients' perceptions of patient-centered behaviors. Patient Educ Couns. 2010 Sep;80(3):315-20. doi: 10.1016/j.pec.2010.06.014. Epub 2010 Jul 17.
PubMed 20638813Burke SR, Myers R, Zhang AL. A profile of osteopathic practice in Australia 2010-2011: a cross sectional survey. BMC Musculoskelet Disord. 2013 Aug 1;14:227. doi: 10.1186/1471-2474-14-227.
PubMed 23915239Cerritelli F, van Dun PLS, Esteves JE, Consorti G, Sciomachen P, Lacorte E, Vanacore N; OPERA-IT Group. The Italian Osteopathic Practitioners Estimates and RAtes (OPERA) study: A cross sectional survey. PLoS One. 2019 Jan 25;14(1):e0211353. doi: 10.1371/journal.pone.0211353. eCollection 2019.
PubMed 30682169Cerritelli F, Verzella M, Barlafante G. Quality of life in patients referring to private osteopathic clinical practice: a prospective observational study. Complement Ther Med. 2014 Aug;22(4):625-31. doi: 10.1016/j.ctim.2014.05.007. Epub 2014 May 24.
PubMed 25146065Cil TD, Easson AM. The role of gender in patient preference for breast surgical care - a comment on equality. Isr J Health Policy Res. 2018 Jul 9;7(1):37. doi: 10.1186/s13584-018-0231-2.
PubMed 29983118Consorti F, Mancuso R, Piccolo A, Consorti G, Zurlo J. Evaluation of the acceptability of Peer Physical Examination (PPE) in medical and osteopathic students: a cross sectional survey. BMC Med Educ. 2013 Aug 22;13:111. doi: 10.1186/1472-6920-13-111.
PubMed 23968312Furnham A, Petrides KV, Temple J. Patient preferences for medical doctors. Br J Health Psychol. 2006 Sep;11(Pt 3):439-49. doi: 10.1348/135910705X67529.
PubMed 16870054Grinberg M, Lopes AS. Feminization of medicine. Arq Bras Cardiol. 2013 Sep;101(3):283. doi: 10.5935/abc.20130175. No abstract available.
PubMed 24061755
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Gender Matter? Patient Preference in an Italian Osteopathic Clinical Setting
- ClinicalTrials.gov ID
- NCT03546114
- Acronym / sponsor ID
- 052018
- Conditions
- Gender Role
- Keywords
- Gender, Sex and gender, Patient preference, Osteopathic medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Istituto Superiore di Osteopatia di MilanoUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 6 Jun 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.
This study evaluates patients preference for the gender of their osteopath. All patients referring to an Italian private osteopathic clinic will receive a proper questionnaire before knowing the gender of their designed osteopath.
Detailed description
Several previous studies have shown that clinical contextual factors, such as patients preferences, play an important role in the patient-physical relationship, with resulting consequences on clinical outcomes.
The interaction between the gender of both patient and physician is often impacted by existing stereotypes.
Patient preference for specific physician gender has been investigated in scientific literature.
However the are no studies that analyzed the role of gender in osteopathic medicine.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referring to an osteopathic clinic - CMO, Milan | – | Other: Gender QuestionnaireAdults, age>18 years, first visit at osteopathic clinic (Centro di Medicina Osteopatica) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referring to Centro di Medicina Osteopatica for the first visit.
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 |
|---|---|---|
| Gender Questionnaire13-items questionnaire including demographics questions (gender, age, education; naive to osteopathic treatment or not; general gender preferences; specific gender preference in case of low back pain, neck pain, gastrointestinal disorders, musculoskeletal disorders of upper and lower limbs pain; headache; urogenital disorders | Other | Patients referring to an osteopathic clinic - CMO, Milan |
Primary outcome
Gender questionnaire (Self-reported 13-items questionnaire)
Time frame: 1 day
* Patient's gender? * Patient's age? * Educational level? (middle school, high school, BSc, MSc, PhD) * Naive to osteopathic treatment? (yes/no) * Only if the answer of question 5 is yes, which was the osteopath's gender at your first osteopathic consultation? * Which would be your favorite osteopath's gender? * Which would be your favorite osteopath's gender if you had low back pain? * Which would be your favorite osteopath's gender if you had neck pain? * Which would be your favorite osteopath's gender if you had gastrointestinal disorders? * Which would be your favorite osteopath's gender if you had upper limb pain? * Which would be your favorite osteopath's gender if you had lower limb pain? * Which would be your favorite osteopath's gender if you had headache? * Which would be your favorite osteopath's gender if you had urogenital disorders? Questions 7-13: Choose among: female, male, no preference
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Background: PubMed 25328483Abghari MS, Takemoto R, Sadiq A, Karia R, Phillips D, Egol KA. Patient perceptions and preferences when choosing an orthopaedic surgeon. Iowa Orthop J. 2014;34:204-8.
- Background: PubMed 29642901Alvarez Bustins G, Lopez Plaza PV, Carvajal SR. Profile of osteopathic practice in Spain: results from a standardized data collection study. BMC Complement Altern Med. 2018 Apr 11;18(1):129. doi: 10.1186/s12906-018-2190-0.
- Background: PubMed 27222116Amir H, Beri A, Yechiely R, Amir Levy Y, Shimonov M, Groutz A. Do Urology Male Patients Prefer Same-Gender Urologist? Am J Mens Health. 2018 Sep;12(5):1379-1383. doi: 10.1177/1557988316650886. Epub 2016 May 24.
- Background: PubMed 25186236Amodio DM. The neuroscience of prejudice and stereotyping. Nat Rev Neurosci. 2014 Oct;15(10):670-82. doi: 10.1038/nrn3800. Epub 2014 Sep 4.
- Background: PubMed 22399872Balayla J. Male physicians treating Female patients: Issues, Controversies and Gynecology. Mcgill J Med. 2011 Jun;13(1):72. No abstract available.
- Background: PubMed 21235412Bishop FL, Massey Y, Yardley L, Lewith GT. How patients choose acupuncturists: a mixed-methods project. J Altern Complement Med. 2011 Jan;17(1):19-25. doi: 10.1089/acm.2010.0061. Epub 2011 Jan 16.
- Background: PubMed 23374205Bishop FL, Bradbury K, Hj Jeludin NN, Massey Y, Lewith GT. How patients choose osteopaths: a mixed methods study. Complement Ther Med. 2013 Feb;21(1):50-7. doi: 10.1016/j.ctim.2012.10.003. Epub 2012 Nov 15.
- Background: PubMed 20638813Blanch-Hartigan D, Hall JA, Roter DL, Frankel RM. Gender bias in patients' perceptions of patient-centered behaviors. Patient Educ Couns. 2010 Sep;80(3):315-20. doi: 10.1016/j.pec.2010.06.014. Epub 2010 Jul 17.
- Background: PubMed 23915239Burke SR, Myers R, Zhang AL. A profile of osteopathic practice in Australia 2010-2011: a cross sectional survey. BMC Musculoskelet Disord. 2013 Aug 1;14:227. doi: 10.1186/1471-2474-14-227.
- Background: PubMed 30682169Cerritelli F, van Dun PLS, Esteves JE, Consorti G, Sciomachen P, Lacorte E, Vanacore N; OPERA-IT Group. The Italian Osteopathic Practitioners Estimates and RAtes (OPERA) study: A cross sectional survey. PLoS One. 2019 Jan 25;14(1):e0211353. doi: 10.1371/journal.pone.0211353. eCollection 2019.
- Background: PubMed 25146065Cerritelli F, Verzella M, Barlafante G. Quality of life in patients referring to private osteopathic clinical practice: a prospective observational study. Complement Ther Med. 2014 Aug;22(4):625-31. doi: 10.1016/j.ctim.2014.05.007. Epub 2014 May 24.
- Background: PubMed 29983118Cil TD, Easson AM. The role of gender in patient preference for breast surgical care - a comment on equality. Isr J Health Policy Res. 2018 Jul 9;7(1):37. doi: 10.1186/s13584-018-0231-2.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Silvia Ratti, MSc principal investigator
Istituto Superiore di Osteopatia (ISO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Role, run by Istituto Superiore di Osteopatia di Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 9 Aug 2019. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender questionnaire (Self-reported 13-items questionnaire) (time frame: 1 day). 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 NCT03546114, which also lists 49 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 9 Aug 2019.