HysteroscopyNCT05069025
Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients
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 outpatient hysteroscopy on patients' level of pain and satisfaction in primarily infertile patients. 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
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2021to 30 Apr 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
- women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
Who cannot join
- women with suspected pregnancy
- heavy vaginal bleeding recent pelvic infection those who received analgesics prior to OH a concomitant neurologic disease that could affect the correct evaluation of pain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients: Prospective Randomized Trial
The aim of this study is to demonstrate the value of music in outpatient hysteroscopy on patients' level of pain and satisfaction in primarily infertile patients.
- 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 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 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 analogue scale during the procedure.visual analogue scale ranging from 0 to 10
Measured: 5 minutes
Secondary outcomes (2)
Intensity of pain
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Measured: 30 minutes
women satisfaction
satisfaction will be assessed by visual analogue scale-like scale ranging from 0 to 10 (0=no satisfaction; 10=maximal satisfaction)
Measured: 30 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 start10 Oct 2021 (estimated)
- Primary completion10 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
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
- 130 participants (estimated)
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
- NCT05069025
- Sponsor's protocol ID
- a8233
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05069025
- Acronym / sponsor ID
- a8233
- Conditions
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Hospital El Gezeera
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 10 Apr 2022 (estimated)
- Study completion
- 30 Apr 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 outpatient hysteroscopy on patients' level of pain and satisfaction in primarily infertile patients.
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 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)
- women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
Key exclusion criteria (2 listed)
- women with suspected pregnancy
- heavy vaginal bleeding recent pelvic infection those who received analgesics prior to OH a concomitant neurologic disease that could affect the correct evaluation of pain
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 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 analogue scale during the procedure.visual analogue scale ranging from 0 to 10
2 secondary outcomes
Intensity of pain
Time frame: 30 minutes
women satisfaction
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hysteroscopy
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
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.
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 2 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 6 Oct 2021. 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?
Contact AHMED SAMY (01100681167, ahmedsamy8233@gmail.com), or a site near the patient. 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 6 Oct 2021.