HysterosalpingographyNCT05069064
Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography
A study testing music and no music in people with Hysterosalpingography, run by Cairo University.
Trial summary
The aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction. Read more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Hysterosalpingography
- What is being tested?
- music and no music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2021to 15 Jun 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 19 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility; patients aged 19 to 42 years; candidate for hysterosalpingography.
Who cannot join
- Severe dysmenorrhea; pelvic infections; drug sensitivity; unwillingness to participate in the study; presence of psychiatric disorders, use of psychotropic medications; secondary infertility.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography: a Randomized Controlled Trial
The aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.
- Conditions
- Hysterosalpingography
- 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 headphone in order to maintain a good communication and interaction between the participant and the doctor.
no musicOther
Participants in the non-music group will undergo hysterosalpingography 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 hysterosalpingography 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.
pain During contrast medium injection
pain will be assessed by visual analog scale from 0 to 10
Measured: 5 minutes
Secondary outcomes (1)
pain after hysterosalpingography
pain will be assessed by visual analog scale from 0 to 10
Measured: 10 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 start5 Oct 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterosalpingographyStudies 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
- 108 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
- NCT05069064
- Sponsor's protocol ID
- hysterosalpingography music
- 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
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
- Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05069064
- Acronym / sponsor ID
- hysterosalpingography music
- Conditions
- Hysterosalpingography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Hospital El Gezeera
- Study start
- 5 Oct 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 15 Jun 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 infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.
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 hysterosalpingography in the same setting and standard procedure without listening to any music. |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertility; patients aged 19 to 42 years; candidate for hysterosalpingography.
Key exclusion criteria (1 listed)
- Severe dysmenorrhea; pelvic infections; drug sensitivity; unwillingness to participate in the study; presence of psychiatric disorders, use of psychotropic medications; secondary infertility.
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 headphone in order to maintain a good communication and interaction between the participant and the doctor. | Other | music group |
| no musicParticipants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music. | Other | non-music group |
Primary outcome
pain During contrast medium injection
Time frame: 5 minutes
pain will be assessed by visual analog scale from 0 to 10
1 secondary outcome
pain after hysterosalpingography
Time frame: 10 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.
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Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial
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The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study
Infertility
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Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility
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Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
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Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Infertility
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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.
Questions about this trial
What is this clinical trial studying?
A study testing music and no music in people with Hysterosalpingography, 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: 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?
pain During contrast medium injection (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.