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The purpose of this study is:
Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen sodium | Experimental | 550 mg naproxen sodium |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen sodium | Drug | 550 mg, oral, on day 1. Number of Cycles: 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) | Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Immediately after IUD insertion is complete |
| Measure | Description | Time Frame |
|---|---|---|
| Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD, MPH | PPLM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood League of Massachusetts | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27824753 | Derived | Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen Sodium | 550 mg naproxen sodium Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1 |
| FG001 | Placebo | Placebo Placebo tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen Sodium | 550 mg naproxen sodium Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1 |
| BG001 | Placebo | Placebo Placebo tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) | Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately after IUD insertion is complete |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen Sodium | 550 mg naproxen sodium Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal episode | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Planned Parenthood League of Massachusetts | 6176298603 | jfortin@pplm.org |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo tablet |
| Other |
|
| Immediately after tenaculum is placed on cervix |
| Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Immediately after uterine sounding |
| Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Five minutes after IUD insertion is complete |
| Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Fifteen minutes after IUD insertion is complete |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Highest level of education | Count of Participants | Participants |
|
| Diagnosed with chronic pain condition (yes) | Count of Participants | Participants |
|
| Diagnosed with depression (yes) | Count of Participants | Participants |
|
| Baseline stress, self-report | This measure asked the following: "How stressed have you felt in the past week on a scale of 0-10, where 0 is not stressed at all and 10 is the most stressed ever". Participants were then able to circle any whole number from 0-10 to indicate their answer. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline sadness, self-report | This measure asked the following: "How sad have you felt in the past week on a scale of 0-10, where 0 is not sad at all and 10 is the most sad ever". Participants were then able to circle any whole number from 0-10 to indicate their answer. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline anxiety, self-report | This measure asked the following: "On a scale of 0 to 10, where 0 is no anxiety and 10 is the most anxious you could be, how have you been feeling in the past week?". Participants were then able to circle any whole number from 0-10 to indicate their answer. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline pain tolerance, self report | This measure asked the following: "How would you rate your pain tolerance (ability to handle pain) in general?". Response choices included: Very low (not much at all), Low, Moderate, High, or Very High (Can tolerate a lot of pain). Patients were asked to check the box of the choice that was correct for them. Conversions to numerical values were as follows: Very low = 1 Low = 2 Moderate = 3 High = 4 Very high = 5 | Median | Inter-Quartile Range | units on a scale |
|
| Expected pain for IUD insertion | This measure asked the following: "On a scale of 0 to 10, where 0 is no anxiety and 10 is the most anxious you could be, how anxious are you about the IUD placement?". Participants were then able to circle any whole number from 0-10 to indicate their answer. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 |
| Placebo |
Placebo Placebo tablet |
|
|
| Secondary | Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately after tenaculum is placed on cervix |
|
|
|
| Secondary | Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately after uterine sounding |
|
|
|
| Secondary | Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Posted | Median | Inter-Quartile Range | units on a scale | Five minutes after IUD insertion is complete |
|
|
|
| Secondary | Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure. | Posted | Median | Inter-Quartile Range | units on a scale | Fifteen minutes after IUD insertion is complete |
|
|
|
| 0 |
| 58 |
| 2 |
| 58 |
| EG001 | Placebo | Placebo Placebo tablet | 0 | 60 | 3 | 60 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |