Ciropractic Care and Pregnant Women (ChiroPW)
June 4, 2021 updated by: Pablo Perez de la Ossa, Barcelona College of Chiropractic
The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08034
- Barcelona College of Chiropractic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
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
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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.
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-36 questionnaire Quality of Life
Time Frame: 4 weeks
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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
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4 weeks
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 weeks
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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.
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4 weeks
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Numeric pain rating scale
Time Frame: 4 weeks
|
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.
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
May 10, 2018
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
June 4, 2021
First Submitted That Met QC Criteria
June 4, 2021
First Posted (Actual)
June 9, 2021
Study Record Updates
Last Update Posted (Actual)
June 9, 2021
Last Update Submitted That Met QC Criteria
June 4, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCC2018AJ
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.