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

Completed

• Conditions: Labour Pain

• Registration Number: NCT01177046
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 752

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada