MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

NCT ID: NCT06783920

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-22

Study Completion Date

2025-10-15

Brief Summary

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The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women

Detailed Description

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The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women

Conditions

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Intrauterine Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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music group

Group Type EXPERIMENTAL

music

Intervention Type PROCEDURE

music will be played during the copper IUD insertion

no-music group

Group Type PLACEBO_COMPARATOR

no music

Intervention Type PROCEDURE

IUD insertion will be done as usual without music

Interventions

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music

music will be played during the copper IUD insertion

Intervention Type PROCEDURE

no music

IUD insertion will be done as usual without music

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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AHMED ASHOUR, MD

Role: CONTACT

Other Identifiers

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music IUD

Identifier Type: -

Identifier Source: org_study_id

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