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