Intrauterine DeviceNCT06783920
MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
A study testing music and no music in people with Intrauterine Device, run by Cairo University.
Trial summary
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrauterine Device
- What is being tested?
- music and no music
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2025to 15 Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.
Who cannot join
- a prior pregnancy greater than 20 weeks of duration
- currently pregnant or were pregnant within 6 weeks of study entry
- had a prior attempted or successful IUD insertion
- had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD active vaginitis or cervicitis
- undiagnosed abnormal uterine bleeding
- pelvic inflammatory disease within the last 3 months
- fibroids or other uterine abnormalities distorting the uterine cavity
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 Copper T380A Intrauterine Device Insertion in Nulliparous Women.
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women
Read the detailed description
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women
- Conditions
- Intrauterine Device
- Being tested
- music, no music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicProcedure or surgery
music will be played during the copper IUD insertion
no musicProcedure or surgery
IUD insertion will be done as usual without music
| Study group | Role | What they receive |
|---|---|---|
| music group | Experimental | Not described Receives: Procedure: music |
| no-music group | Placebo comparator | Not described Receives: Procedure: no music |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during IUD insertion
pain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt
Measured: 5 minutes
Secondary outcomes (1)
anxiety during IUD insertion
anxiety will be measured by the 10 cm like visual analog scale where 0 denotes no anxiety, and 10 denotes maximal anxiety
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start22 Feb 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine DeviceStudies 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
- 100 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
- NCT06783920
- Sponsor's protocol ID
- music IUD
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 20 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 20 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 Copper T380A Intrauterine Device Insertion in Nulliparous Women.
- ClinicalTrials.gov ID
- NCT06783920
- Acronym / sponsor ID
- music IUD
- Conditions
- Intrauterine Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Feb 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 20 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.
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women
Detailed description
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women
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 |
| no-music group | Placebo comparator | Procedure: no music |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.
Key exclusion criteria (7 listed)
- a prior pregnancy greater than 20 weeks of duration
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 |
|---|---|---|
| musicmusic will be played during the copper IUD insertion | Procedure or surgery | music group |
| no musicIUD insertion will be done as usual without music | Procedure or surgery | no-music group |
Primary outcome
pain during IUD insertion
Time frame: 5 minutes
pain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt
1 secondary outcome
anxiety during IUD insertion
Time frame: 5 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 20 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.
Questions about this trial
What is this clinical trial studying?
A study testing music and no music in people with Intrauterine Device, 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 7 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 20 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. Some participants in this study may receive a placebo. 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 ASHOUR, MD (35690992, 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 IUD insertion (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 20 Jan 2025.