MUSIC Prior to a T380A Intrauterine Device Insertion in N... | NCT06783920

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

NCT06783920

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Jan 20, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Intrauterine Device

Interventions

music
no music

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2025Estimated

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 15, 2025Estimated

First Submitted Date

Jan 15, 2025

First Submission Date that Met QC Criteria

Jan 15, 2025

First Posted Date

Jan 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2025

Last Update Posted Date

Jan 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
music group	Experimental		Procedure: music
no-music group	Placebo Comparator		Procedure: no music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
music	Procedure	music will be played during the copper IUD insertion	music group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
anxiety during IUD insertion	anxiety will be measured by the 10 cm like visual analog scale where 0 denotes no anxiety, and 10 denotes maximal anxiety	5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AHMED ASHOUR, MD	Contact	35690992		ahmedsamy8233@gmail.com

Overall Officials

Not provided

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided