The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

NCT ID: NCT04602897

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-03-25

Brief 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).

Detailed 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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cough group

The cough group patients were asked to cough a forced cough during different steps of IUD insertion

Group Type: EXPERIMENTAL

forced coughing

Intervention Type: OTHER

The cough group patients were asked to cough a forced cough during different steps of IUD insertion

control

the control group received no pain management at all during different steps of IUD insertion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

forced coughing

The cough group patients were asked to cough a forced cough during different steps of IUD insertion

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Nabih Elkhouly

Asssistant professor of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nabih Elkhouly, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of obstetrics and gynecology, faculty of medicine menoufia university

Locations

Menoufia university hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

12-2019OBSGN38

Identifier Type: -

Identifier Source: org_study_id