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

Labour Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177046
• Other study ID #: 160-2002
• Status: Completed
• Start date: July 2010
• Est. completion date: October 2021

Study information

• Verified date: June 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Labour Pain

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

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