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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Intrauterine Device

Treatments: Procedure: no music; Procedure: music

Study type: Interventional

Funder types: Other

Identifiers

NCT06783920

music IUD

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

music group

Experimental group

Treatment:

Procedure: music

no-music group

Placebo Comparator group

Treatment:

Procedure: no music