NCT06783920

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 15, 2025

Last Update Submit

January 15, 2025

Conditions

Intrauterine Device

Outcome Measures

Primary Outcomes (1)

  • pain during IUD insertion

    pain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt

    5 minutes

Secondary Outcomes (1)

  • anxiety during IUD insertion

    5 minutes

Study Arms (2)

music group

EXPERIMENTAL
Procedure: music

no-music group

PLACEBO COMPARATOR
Procedure: no music

Interventions

musicPROCEDURE

music will be played during the copper IUD insertion

music group
no musicPROCEDURE

IUD insertion will be done as usual without music

no-music group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

AHMED ASHOUR, MD

CONTACT

35690992ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

February 22, 2025

Primary Completion

October 1, 2025

Study Completion

October 15, 2025

Last Updated

January 20, 2025

Record last verified: 2025-01