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

January 15, 2025 updated by: Ahmed Samy aly ashour, Cairo University

EFFECT of MUSIC in Reducing Pain and Anxiety During Copper 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: music group
Procedure: music
music will be played during the copper IUD insertion
Placebo Comparator: no-music group
Procedure: no music
IUD insertion will be done as usual without music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 22, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • music IUD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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