PainNCT06772636
Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility
A study testing music group and non music group in people with Pain, run by Cairo University.
Trial summary
This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- music group and non music group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.
Who cannot join
- Using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, Current pregnancy or suspicion of pregnancy.Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility: a Randomized Controlled Trial
This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility
Read the detailed description
This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility
- Conditions
- Pain
- Being tested
- music group, non music group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music groupProcedure or surgery
In the music group, the 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 groupProcedure or surgery
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 | Not described Receives: Procedure: music group |
| non-music group | Other | Not described Receives: Procedure: non music group |
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 10 where 0 denotes no pain and 10 denotes maximum pain felt
Measured: 10 minutes
Secondary outcomes (1)
anxiety during procedure
anxiety will be measured using 10 cm VAS like score where 0 denotes no anxiety and 10 represents maximum anxiety
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 posted13 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion10 Aug 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772636
- Sponsor's protocol ID
- MUSIC HSG
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 13 Jan 2025
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06772636
- Acronym / sponsor ID
- MUSIC HSG
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 13 Jan 2025 (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 aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility
Detailed description
This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music group | Experimental | Procedure: music group |
| non-music group | Other | Procedure: non music group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.
Key exclusion criteria (1 listed)
- Using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, Current pregnancy or suspicion of pregnancy.Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
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 |
|---|---|---|
| music groupIn the music group, the 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. | Procedure or surgery | music group |
| non music groupParticipants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music. | Procedure or surgery | non-music group |
Primary outcome
Intensity of pain
Time frame: 10 minutes
Pain intensity will be assessed by visual analog scale during the procedure. visual analog scale ranging from 0 to 10 where 0 denotes no pain and 10 denotes maximum pain felt
1 secondary outcome
anxiety during procedure
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing music group and non music group in people with Pain, 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: opening soon, as of the sponsor's last update on 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY ALI ASHOUR, MD (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: 10 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 13 Jan 2025.