Fast Versus Slow Application of Vulsellum During Intrauterine Device Insertion

Improving Quality of Life Clinical Trial

Official title:

the Effect of Slow Versus Fast Application of Vulsellum on Pain Perception During Intrauterine Device Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878135
• Other study ID #: SLVOL
• Status: Completed
• Phase: N/A
• First received: August 22, 2016
• Last updated: July 31, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women not taken analgesics or anxiolytics in the 24 hours prior insertion

• Women not taken misoprostol prior to intrauterine device insertion

• Women who will accept to participate in the study

Exclusion Criteria:

Any contraindication to intrauterine device placement

Related Conditions & MeSH terms

• Improving Quality of Life

Intervention

Procedure:
• fast application

• slow application

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean Pain score with vulsellum placement		5 minutes