The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

Pain Clinical Trial

Official title:

The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602897
• Other study ID #: 12-2019OBSGN38
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 25, 2020

Study information

• Verified date: October 2020
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a randomized controlled trial of 400 women who attended the outpatient clinic of Menoufia University Hospital for copper IUD insertion. The women were randomly assigned to cough and control groups.The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).

Description:

We conducted this randomized controlled trial at the Department of Obstetrics and Gynecology at Menoufia University Hospital, Egypt, from May 2018 to March 2020. Our hospital research ethics committee approved this study. We obtained informed consent from all participants before initiating any study procedures. CONSORT guidelines were observed and completed.

We recruited non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception. Eligible women had no prior vaginal delivery or pregnancy termination beyond 12 weeks, gestation (as patulous cervical os may affect VAS score), any previous deliveries had been by cesarean section, they were immediately postmenstrual or 1 week after pregnancy termination and they were willing to complete the study questionnaires. All women had to be alert, oriented, and cooperative to respond easily to VAS.

Exclusion criteria were current pregnancy, prior vaginal delivery, history of cervical stenosis, current pelvic inflammatory disease, uterine anomalies, undiagnosed abnormal uterine bleeding, fibroids distorting the uterine cavity, and patients using chronic NSAIDs or on chronic pain medication.

We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 25, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception.

• No prior vaginal delivery or pregnancy termination beyond 12 weeks gestation (as patulous cervical os may affect VAS score).

• Any previous deliveries had been by cesarean section.

• Immediately postmenstrual or 1 week after pregnancy termination.

• They were willing to complete the study questionnaires.

• All women had to be alert, oriented, and cooperative to respond easily to VAS.

Exclusion criteria were:

• Current pregnancy.

• Prior vaginal delivery.

• History of cervical stenosis.

• Current pelvic inflammatory disease.

• Uterine anomalies.

• Undiagnosed abnormal uterine bleeding.

• Fibroids distorting the uterine cavity.

• Patients using chronic NSAIDs or on chronic pain medication. We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent

Related Conditions & MeSH terms

• Cough
• Pain

Intervention

Other:
• forced coughing
The cough group patients were asked to cough a forced cough during different steps of IUD insertion

Locations

Country	Name	City	State
Egypt	Menoufia university hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).	The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).	Up to 22 months