Development of a Multi-attribute Health Index to Measure the Quality of Labour Analgesia: Psychometric Development of a Quality of Neuraxial Labour Analgesia Scale

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01177046
First received: August 4, 2010
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

The current lack of a tool to measure the overall quality of neuraxial pain relief provided in labour analgesia trials has produced studies unable to provide clear direction to clinical care and research. Our previous work explored and described the underlying dimensions and attributes of quality neuraxial analgesia from the perspectives of labouring women as the initial phase of development of an Index to measure this as an outcome in research. We now seek to confirm our findings as well as to generate additional items (descriptors) of quality neuraxial analgesia from the perspectives of parturients and experts (obstetrical anesthesiologists and experienced labour nurses). Once generated, the full list of items will be used to in a subsequent study involving only parturients (Item Reduction phase) to develop a scale permitting global measurement of quality neuraxial labour analgesia. The resulting scale, once validated, will provide researchers with a simple global measure for quality in labour analgesia research. This scale will be used later in our program of research to assist with validation studies of the larger Multi-attribute Health Index we are developing.


Condition
Labour Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Sunnybrook Health Sciences Centre:

Estimated Enrollment: 60
Study Start Date: July 2010
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women who received neuraxial labour analgesia during the current pregnancy

Criteria

Inclusion Criteria:

  1. Use of neuraxial labour analgesia during the current pregnancy
  2. Native English-speakers
  3. Term pregnancies (>37-42weeks)
  4. The ability to read and write in English
  5. Provision of written informed consent.

Exclusion Criteria:

  1. Women who received IM or IV narcotics within 4 hours of epidural/ combined spinal epidural (CSE) placement
  2. Women with evidence or history of maternal cognitive impairment
  3. Women who experienced a neonatal death during the current pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177046

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Dr. Pamela Angle, MD, MSc    416-323-6400 ext 6269      
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Dr. Pamela Angle, MD, MSc Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Pamela Angle, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01177046     History of Changes
Other Study ID Numbers: 160-2002
Study First Received: August 4, 2010
Last Updated: July 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Women receiving a labour epidural during most recent delivery

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014