AdultsPNE-DELPHINCT07096661
Pain Science Education for Labour and Postpartum Pain
An observational study of Adults and Female, run by Bournemouth University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adults, Female, Labour Pain
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Inability to read or write in English
- Lack of relevant professional background or clinical experience as outlined in the inclusion criteria
- Decline or fail to provide informed consent
- Under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Expert Perspectives on Pain Science Education for Labour and Postpartum Pain: A Delphi Study
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.
Read the detailed description
Labour pain is a critical and complex experience that can significantly influence both immediate and long-term maternal outcomes. Although antenatal education often addresses pain minimally or inconsistently, pain science education (PSE)-which reconceptualizes pain as a biopsychosocial phenomenon-has demonstrated benefits in other clinical contexts, such as chronic pain and musculoskeletal rehabilitation. PSE may reduce fear, enhance coping strategies, and support physiological birth outcomes. However, its integration into maternity care, particularly during labour and postpartum periods, has yet to be defined.
This study employs a three-round electronic Delphi (e-Delphi) methodology to gain consensus on the use of PSE in this context. The Delphi method is ideal for topics where empirical evidence is limited but expert opinion is available. Guided by established best practices including the CREDES (Guidance on Conducting and REporting DElphi Studies) this study ensures methodological rigour and transparency.
Multidisciplinary experts will be purposively recruited internationally via professional networks and social media platforms. To participate, experts must be English-speaking adults with relevant clinical experience or academic contributions in PSE, pain management, or antenatal education. The study will include physiotherapists, midwives, gynaecologists, psychologists, nurses, and pain specialists. Participants will be provided with detailed study information and will give informed consent electronically.
The Delphi process will be conducted in three iterative rounds, allowing experts to respond anonymously to survey items, review aggregate group feedback, and refine their views. This method aims to identify convergence in expert perspectives and clarify the key components of a future PSE intervention for labour and postpartum care. Data will be analysed using NVivo for qualitative responses and SPSS for quantitative analysis.
The outcome of this study will inform the development of a clearly defined, evidence-informed PSE intervention to be tested in future clinical trials. It represents an important step toward improving antenatal education and enhancing pain management during and after childbirth.
- Conditions
- Adults, Female, Labour Pain, Postpartum Pain, Chronic Pain
- Keywords
- Pain Neuroscience Education, PNE, Postpartum Pain, Natal Pain, Labor Pain, Delphi Study, persistent pain
- Medical subject headings
- Labor Pain, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 2
Secondary outcomes (1)
Qualitative Insights into Implementation Feasibility and Barriers
Open-ended responses collected during the e-Delphi rounds will be analysed thematically to identify perceived barriers, facilitators, and implementation considerations for integrating PSE into routine antenatal care. Data will be analysed using qualitative content analysis in NVivo, with codes developed inductively and reviewed by multiple researchers to ensure rigour.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University, Vrije Universiteit Brussel, McMaster University
- Responsible party
- Principal investigator, Omer Elma, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096661
- Sponsor's protocol ID
- 61318
- Acronym
- PNE-DELPHI
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Perspectives on Pain Science Education for Labour and Postpartum Pain: A Delphi Study
- ClinicalTrials.gov ID
- NCT07096661
- Acronym / sponsor ID
- PNE-DELPHI / 61318
- Conditions
- Adults, Female, Labour Pain, Postpartum Pain, Chronic Pain
- Keywords
- Pain Neuroscience Education, PNE, Postpartum Pain, Natal Pain, Labor Pain, Delphi Study, persistent pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Akdeniz University, Vrije Universiteit Brussel, McMaster University
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Labour pain is a critical and complex experience that can significantly influence both immediate and long-term maternal outcomes. Although antenatal education often addresses pain minimally or inconsistently, pain science education (PSE)-which reconceptualizes pain as a biopsychosocial phenomenon-has demonstrated benefits in other clinical contexts, such as chronic pain and musculoskeletal rehabilitation. PSE may reduce fear, enhance coping strategies, and support physiological birth outcomes. However, its integration into maternity care, particularly during labour and postpartum periods, has yet to be defined.
This study employs a three-round electronic Delphi (e-Delphi) methodology to gain consensus on the use of PSE in this context. The Delphi method is ideal for topics where empirical evidence is limited but expert opinion is available. Guided by established best practices including the CREDES (Guidance on Conducting and REporting DElphi Studies) this study ensures methodological rigour and transparency.
Multidisciplinary experts will be purposively recruited internationally via professional networks and social media platforms. To participate, experts must be English-speaking adults with relevant clinical experience or academic contributions in PSE, pain management, or antenatal education. The study will include physiotherapists, midwives, gynaecologists, psychologists, nurses, and pain specialists. Participants will be provided with detailed study information and will give informed consent electronically.
The Delphi process will be conducted in three iterative rounds, allowing experts to respond anonymously to survey items, review aggregate group feedback, and refine their views. This method aims to identify convergence in expert perspectives and clarify the key components of a future PSE intervention for labour and postpartum care. Data will be analysed using NVivo for qualitative responses and SPSS for quantitative analysis.
The outcome of this study will inform the development of a clearly defined, evidence-informed PSE intervention to be tested in future clinical trials. It represents an important step toward improving antenatal education and enhancing pain management during and after childbirth.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to read or write in English
- Lack of relevant professional background or clinical experience as outlined in the inclusion criteria
- Decline or fail to provide informed consent
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expert Consensus on Content of Pain Science Education for Labour and Postpartum
Time frame: Day 2
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.
Expert Consensus on Optimal Timing for Delivery of Pain Science Education
Time frame: Day 2
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.
Expert Consensus on Preferred Delivery Methods for Pain Science Education
Time frame: Day 2
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.
1 secondary outcome
Qualitative Insights into Implementation Feasibility and Barriers
Time frame: Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults and Female, run by Bournemouth University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expert Consensus on Content of Pain Science Education for Labour and Postpartum (time frame: Day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.