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

NCT06783920 — Not applicable, Not yet recruiting, 100 participants, Cairo University

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

Registry	NCT06783920
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	100 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Intrauterine Device
Interventions	music, no music (Procedure)
Dates	start 2025-02-22 (estimated), primary completion 2025-10-01 (estimated), completion 2025-10-15 (estimated), first posted 2025-01-20, last updated 2025-01-20

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
music group	Experimental	Procedure: music
no-music group	Placebo comparator	Procedure: no music

music (Procedure): music will be played during the copper IUD insertion
no music (Procedure): IUD insertion will be done as usual without music

+Outcome measures

Primary outcomes

pain during IUD insertion [5 minutes]: pain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt

Secondary outcomes

anxiety during IUD insertion [5 minutes]: anxiety will be measured by the 10 cm like visual analog scale where 0 denotes no anxiety, and 10 denotes maximal anxiety

+Eligibility

Sex: Female, ages: 18 Years to any

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