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Not yet recruiting NCT06783920

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

No phase Interventional Intrauterine Device

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: music, no music.
Who it may be relevant to
Registry conditions: Intrauterine Device. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

EFFECT of MUSIC in Reducing Pain and Anxiety During Copper T380A Intrauterine Device Insertion in Nulliparous Women.

Overview

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

Interventions

  • Procedure music
    music will be played during the copper IUD insertion
  • Procedure no music
    IUD insertion will be done as usual without music

Primary outcome measures

  • pain during IUD insertion [Time frame: 5 minutes]
Secondary outcome measures (1)
  • anxiety during IUD insertion [Time frame: 5 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06783920 · music IUD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗