Development of a Multi-attribute Health Index: to Measure the Quality of Labour Analgesia: The QLA Index

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 findings of this research will be used to develop a scale for measuring the quality of epidural pain relief achieved during labour and vaginal delivery.

Study Overview

• Status: Completed
• Conditions: Labour Pain

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 752

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who received neuraxial labour analgesia during the current pregnancy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychometric instrument development study	Exploration and description of language, nature, and variability of women's pain experiences during labour and delivery.	5-6 years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Dr. Pamela Angle, MD, MSc, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: August 4, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Women receiving labour epidural for most recent delivery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 160-2002