Effects of Oral Contraceptives on DNIC in Non-painful Healthy Women

Effects of Oral Contraceptives on Diffuse Noxious Inhibitory Stimulus (DNIC) in Non-painful Healthy Women

The purpose of this study is tu assess the influence of oral contraceptives (OC) on diffuse noxious inhibitory control (DNIC) in healthy women, tested during high, low endogenous estrogens sessions and ovulatory period.

Study Overview

• Status: Completed
• Conditions: Contraceptive Usage; Diffuse Noxious Inhibitory Control
• Intervention / Treatment: Device: Mechanical stimulus; Procedure: Thermal (cold) stimulus; Other: Oral contraceptive (OC); Other: No oral contraceptive (No OC)

Detailed Description

After being informed about the study and it protocol, all patients giving written informed consent, will undergo to a cephalic (masseter) and extracephalic (finger) mechanical stimulus to evaluate the threshold of mechanical pain, and physiological records of systolic/diastolic pressure and heart rates. After, we will evaluate the threshold response and physiological rates to the same mechanical stimulus under a thermal (cold) conditional pain (TCP) at 3 different moments of menstrual period in No contraceptive group (No OC) versus Contraceptive group (CO). Finally, we will compare the mechanical threshold response, physiological rates and pain perception between both groups.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Valparaiso
    • Viña Del Mar, Valparaiso, Chile
      • Universidad Viña del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy women with oral contraceptive treatment (for at least 3 consecutive months), greater than or equal to 15 years old.
• Healthy women without oral contraceptive treatment, greater than or equal to 15 years old.
• Non pregnant women.
• Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
• Without systemic pathologies.

Exclusion Criteria:

• Treatment of a pain, depression, hypertension, convulsion condition with or without medication.
• Regular use of benzodiazepines.
• Systemic pathologies
• Pregnant women
• Menopausal women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral contraceptive (OC); Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.	Device: Mechanical stimulus; Electrical dynamometer to measure mechanical pressure; Procedure: Thermal (cold) stimulus; Water cold bath; Other: Oral contraceptive (OC); Oral contraceptive (OC)
Experimental: No oral contraceptive (No OC); No oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.	Device: Mechanical stimulus; Electrical dynamometer to measure mechanical pressure; Procedure: Thermal (cold) stimulus; Water cold bath; Other: No oral contraceptive (No OC); No oral contraceptive (No OC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women	The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a mechanical pressure in the masseter (cephalic) and finger (extracephalic) stimulus as the "test stimulus" and a cold-water bath as the "conditioning stimulus". The results of this test will be used as the primary outcome measure.	Baseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual period

Collaborators and Investigators

• Sponsor: Universidad Vina del Mar
• Investigators: Principal Investigator: Nicolás Pinto-Pardo, DDS, Ms, Ph.D, Universidad Viña del Mar

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No