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The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
forced coughing
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Intrauterine device, IUD, Pain, Forced coughing

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Menoufia university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cough group

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 16, 2020
Last Updated
October 20, 2020
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04602897
Brief Title
The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion
Official Title
The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Intrauterine device, IUD, Pain, Forced coughing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The cough group patients were asked to cough a forced cough during different steps of IUD insertion
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cough group
Arm Type
Experimental
Arm Description
The cough group patients were asked to cough a forced cough during different steps of IUD insertion
Arm Title
control
Arm Type
No Intervention
Arm Description
the control group received no pain management at all during different steps of IUD insertion
Intervention Type
Other
Intervention Name(s)
forced coughing
Intervention Description
The cough group patients were asked to cough a forced cough during different steps of IUD insertion
Primary Outcome Measure Information:
Title
The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
Description
The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
Time Frame
Up to 22 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabih Elkhouly, MD
Organizational Affiliation
Assistant professor of obstetrics and gynecology, faculty of medicine menoufia university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menoufia university hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

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