NCT07096661

Brief Summary

This Delphi study aims to establish expert consensus on the role, content, and delivery of pain science education (PSE) for labour and postpartum pain management. Despite the growing application of PSE in other populations, its use in maternity care remains underexplored. Through a three-round electronic Delphi survey, multidisciplinary experts-including physiotherapists, midwives, gynaecologists, pain specialists, nurses, and psychologists-will contribute their perspectives to guide the development of a structured PSE intervention for future clinical testing.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

July 14, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

July 14, 2025

Last Update Submit

April 18, 2026

Conditions

Keywords

Pain Neuroscience EducationPNEPostpartum PainNatal PainLabor PainDelphi Studypersistent pain

Outcome Measures

Primary Outcomes (3)

  • Expert Consensus on Content of Pain Science Education for Labour and Postpartum

    Expert consensus will be assessed using a structured three-round electronic Delphi survey. Survey items will ask participants to rate the importance or relevance of specific pain science education topics and components using a 5-point Likert scale (1 = not important to 5 = essential). Consensus will be defined as ≥70% of participants rating an item as either 4 or 5. Quantitative agreement levels will be calculated per item in SPSS, and qualitative comments will be analysed in NVivo to support interpretation of ratings.

    Day 2

  • Expert Consensus on Optimal Timing for Delivery of Pain Science Education

    Expert consensus on optimal time points for delivering pain science education will be assessed using a structured three-round electronic Delphi survey. Participants will rate each proposed timing option using a 5-point Likert scale (1 = not appropriate to 5 = highly appropriate). Consensus will be defined as ≥70% of experts rating an item as 4 or 5. Quantitative data will be analysed using SPSS.

    Day 2

  • Expert Consensus on Preferred Delivery Methods for Pain Science Education

    Expert agreement on preferred delivery formats for PSE (e.g., individual vs. group sessions, online vs. in-person, specific provider roles) will be assessed via a structured e-Delphi survey. Items will be rated on a 5-point Likert scale (1 = not feasible/effective to 5 = highly feasible/effective). Consensus will be defined as ≥70% of participants selecting 4 or 5. Quantitative data will be analysed in SPSS to determine consensus levels.

    Day 2

Secondary Outcomes (1)

  • Qualitative Insights into Implementation Feasibility and Barriers

    Day 3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of 30 multidisciplinary experts recruited internationally, including physiotherapists, midwives, gynaecologists, pain management specialists, nurses, and psychologists. These participants will be selected using purposive sampling to ensure a diverse representation of professional backgrounds and experiences related to pain science education, pain management, and antenatal care.

You may qualify if:

  • Age 18 years or older
  • Ability to read and write in English
  • Professional background as one of the following:
  • Registered physiotherapist Registered midwife Gynaecologist Pain management specialist Nurses Psychologist

You may not qualify if:

  • Inability to read or write in English
  • Decline or fail to provide informed consent
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Landsdowne Campus

Bournemouth, United Kingdom

Location

MeSH Terms

Conditions

Labor PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 31, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations