Ciropractic Care and Pregnant Women

Quality of Life Clinical Trial

— ChiroPW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919278
• Other study ID #: BCC2018AJ
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: June 2021
• Source: Barcelona College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 15, 2018
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Chiropractic adjustments
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.

Locations

Country	Name	City	State
Spain	Barcelona College of Chiropractic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Barcelona College of Chiropractic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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