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NCT Number: NCT06783920

MUSIC Prior to a 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

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Key information

Conditions

Intrauterine Device

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Procedure

music will be played during the copper IUD insertion

no music

Procedure

IUD insertion will be done as usual without music

Primary outcomes

  1. 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

Secondary outcomes

  1. anxiety during IUD insertion

    Time frame: 5 minutes

    anxiety will be measured by the 10 cm like visual analog scale where 0 denotes no anxiety, and 10 denotes maximal anxiety

Study contacts

Contact information is provided by the study sponsor or research team.

AHMED ASHOUR, MD

CONTACT

[email protected]

35690992

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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