HysteroscopyNCT05069077
the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women
A study testing Music and No music in people with Hysteroscopy, run by Cairo University.
Trial summary
The aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Music and No music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2021to 15 May 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
Who cannot join
- patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding
About this study
Official title: the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women: a Randomized Controlled Trial
The aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women
- Conditions
- Hysteroscopy
- Being tested
- Music, No music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.
No musicOther
Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.
| Study group | Role | What they receive |
|---|---|---|
| music group | Experimental | In the music group, music chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor. Receives: Other: Music |
| non-music group | Other | Participants in the non-music group will undergo diagnostic outpatient hysteroscopy in the same setting and standard procedure without listening to any music. Receives: Other: No music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Pain intensity will be assessed by visual analog scale during the procedure. visual analog scale ranging from 0 to 100
Measured: 5 minutes
Secondary outcomes (1)
Intensity of pain
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 100
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completion10 May 2022 (estimated)
- Study completion15 May 2022 (estimated)
Why it stopped: consensus between researchers. Limited time and resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital El Gezeera
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069077
- Sponsor's protocol ID
- hysteroscopy menopause 8233
- Status last verified
- Jan 2025
- First submitted
- 25 Sep 2021
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05069077
- Acronym / sponsor ID
- hysteroscopy menopause 8233
- Conditions
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: consensus between researchers. Limited time and resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Hospital El Gezeera
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 10 May 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 6 Oct 2021 (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.
The aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music group | Experimental | Other: MusicIn the music group, music chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor. |
| non-music group | Other | Other: No musicParticipants in the non-music group will undergo diagnostic outpatient hysteroscopy in the same setting and standard procedure without listening to any music. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
Key exclusion criteria (1 listed)
- patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding
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 |
|---|---|---|
| MusicIn the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor. | Other | music group |
| No musicParticipants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music. | Other | non-music group |
Primary outcome
Intensity of pain
Time frame: 5 minutes
Pain intensity will be assessed by visual analog scale during the procedure. visual analog scale ranging from 0 to 100
1 secondary outcome
Intensity of pain
Time frame: 20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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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?
A study testing Music and No music in people with Hysteroscopy, run by Cairo 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 1 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: withdrawn, as of the sponsor's last update on 17 Jan 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Intensity of pain (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
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 17 Jan 2025.