Ciropractic Care and Pregnant Women

Study Overview
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Brief Summary
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Objective: The aim of this study is to investigate the effectiveness of Chiropractic care on pain, quality of life and sleep in pregnant women compared to a control group. The study is designed as non-randomized controlled trial. Forty-two pregnant women at least on the 14th week of gestation will be included. Control group will include women receiving regular care, but no chiropractic care. Care will extend for 4 weeks. Outcomes measures include sleep quality, pain and quality of life questionnaires.

Official Title
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The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women

Conditions
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Pain, Back, Pregnancy Related, Sleep, Quality of Life

Intervention / Treatment
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* Procedure: Chiropractic adjustments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women over the age of 18 of at least 14 weeks gestation, with a good understanding of English, Spanish or French. Exclusion Criteria: women over the age of 45, pregnancies of more than 35 weeks gestation high-risk pregnancies (tobacco, alcohol or substance use, diagnosed medical conditions or high blood pressure).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will be evaluated for any health contraindication. Once reviewed they will received full spine chiropractic treatment for 4 weeks, at the rate of one adjustment per week. After three visits they will complete the outcome measures | Procedure: Chiropractic adjustments<br>* Chiropractic adjustment is a procedure in which trained specialists (chiropractors) use their hands or a small instrument to apply a controlled, sudden force to a spinal joint. The goal of this procedure, also known as spinal manipulation, is to improve spinal motion and improve your body's physical function.<br>|
| No Intervention: Control group<br>Paticipants will be selected amongst thse attending predelivery sessions. They receive no chiropracti care. They will complete the outcomes at the same time as the Intervention group and then 4 weeks later. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 questionnaire Quality of Life | The Short Form-36 Health Survey (SF-36) is one of the most frequently used and evaluated health-related quality of life measures for pregnancy. It is composed of 36 questions (items) that evaluate both positive and negative states of health. The questionnaire assesses eight dimensions: physical functioning, role limitation from physical health problems, bodily pain, general health, vitality, social functioning, and role limitation from emotional health problems | 4 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire, which evaluates sleep quality and disturbances over a period of one month. It is composed of nineteen individual items creating seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction and the total PSQI score. | 4 weeks | 
| Numeric pain rating scale | The Numeric Rating Scale (NRS) is among the most commonly used measures of pain intensity in clinical and research settings. The NRS is an 11-point scale, from 0 to 10 with 0 indicating no pain and 10 representing the worst imaginable pain. Participants select the number that best represents their pain intensity. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chiropractic