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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06783920
Enrollment
100
Registered
2025-01-20
Start date
2025-02-22
Completion date
2025-10-15
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Device

Brief summary

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

PROCEDUREmusic

music will be played during the copper IUD insertion

PROCEDUREno music

IUD insertion will be done as usual without music

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain during IUD insertion5 minutespain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt

Secondary

MeasureTime frameDescription
anxiety during IUD insertion5 minutesanxiety will be measured by the 10 cm like visual analog scale where 0 denotes no anxiety, and 10 denotes maximal anxiety

Contacts

Primary ContactAHMED ASHOUR, MD
ahmedsamy8233@gmail.com35690992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026