PainNCT01703871
Music During Diagnostic Hysteroscopy
An observational study of Pain and Anxiety, run by Campus Bio-Medico University.
Trial summary
Office Hysteroscopy is associated with a level of anxiety that could condition tolerability of the procedure by the patient. The aim of this study is to evaluate the impact of music on anxiety state, expected and received pain by patients during office hysteroscopy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain, Anxiety, Tolerability
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to not given
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Patients candidates for office hysteroscopy in menopausal status or in childbearing age
Who cannot join
- Previous diagnostic hysteroscopy and/or RCU
- Current or recent pelvic Inflammation
- Invasive cervix cancer
- Ongoing pregnancy
About this study
Office Hysteroscopy is associated with a level of anxiety that could condition tolerability of the procedure by the patient.
The aim of this study is to evaluate the impact of music on anxiety state, expected and received pain by patients during office hysteroscopy.
- Conditions
- Pain, Anxiety, Tolerability
- Medical subject headings
- Pain, Anxiety Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cafa Ester Valentina, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703871
- Sponsor's protocol ID
- HM-1
- Status last verified
- Sep 2012
- First submitted
- 8 Oct 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music During Diagnostic Hysteroscopy
- ClinicalTrials.gov ID
- NCT01703871
- Acronym / sponsor ID
- HM-1
- Conditions
- Pain, Anxiety, Tolerability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Sep 2012
- First posted
- 11 Oct 2012 (estimated)
- 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.
Office Hysteroscopy is associated with a level of anxiety that could condition tolerability of the procedure by the patient.
The aim of this study is to evaluate the impact of music on anxiety state, expected and received pain by patients during office hysteroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Patients candidates for office hysteroscopy in menopausal status or in childbearing age
Key exclusion criteria (4 listed)
- Previous diagnostic hysteroscopy and/or RCU
- Current or recent pelvic Inflammation
- Invasive cervix cancer
- Ongoing pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by Campus Bio-Medico University.
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 1 inclusion and 4 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 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 11 Oct 2012.