PainNCT05698290
HELP Pain Training Program
An observational study of Pain, run by Michigan State University at 1 site in United States.
Trial summary
The aim of this project is to develop and test the Helping Educators Learn Pediatric Pain Assessment \& Intervention Needs (HELP Pain) program. HELP Pain provides training for school providers (e.g., school nurses, mental health professionals) on strategies to assess and manage pain-related concerns in school… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pain
- What is being tested?
- HELP Pain Training Program
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to Nov 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Providers (nurses and mental health professionals) serving Michigan schools.
Who may be able to join
- engaged as a school provider in Michigan
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
Grand Rapids, Michigan, 49503
About this study
Official title: Engaging School Providers to Manage Student Pain in Michigan Schools
The aim of this project is to develop and test the Helping Educators Learn Pediatric Pain Assessment \& Intervention Needs (HELP Pain) program. HELP Pain provides training for school providers (e.g., school nurses, mental health professionals) on strategies to assess and manage pain-related concerns in school children. Participants will learn cognitive behavioral therapy techniques to help school children manage pain, and report on their use of strategies, and child's progress throughout the school year. Follow-up data will be collected in year 2.
Read the detailed description
Chronic pain is common among school children, and impacts social, emotional and academic functioning. School providers are often tasked with addressing student pain, but may have limited training in evidence-based pain management strategies. Thus, the PI developed a training program, HELP Pain, to train school providers, such as school nurses and mental health professionals, in cognitive behavioral therapy strategies for addressing student pain. In this study, the feasibility and acceptability of the training program will be evaluated. Provider knowledge will be evaluated before and after receiving the HELP Pain training. Further, the use of HELP Pain strategies with students and their associated disability and pain outcomes will be evaluated. Results will help to tailor the HELP Pain training program for future use.
- Conditions
- Pain
- Being tested
- HELP Pain Training Program
- Keywords
- Pain, Cognitive Behavioral Therapy, School Providers
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELP Pain Training ProgramOther
A training program to teach school providers nonpharmacologic (e.g., cognitive behavioral and mindfulness meditation) strategies to use with students with pain symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Health Department of Northwest Michigan | School providers (school nurses, mental health specialists) from the Health Department of Northwest Michigan. Receives: Other: HELP Pain Training Program | |
| Michigan Association of School Nurses | School providers (nurses) from the Michigan Association of School Nurses. Receives: Other: HELP Pain Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Qualitative report
Implementation success of the program measured by a semi-structured qualitative interview method which addresses feasibility.
Measured: 9 months
Acceptability - Qualitative report
Implementation success of the program measured by a semi-structured qualitative interview method which addresses acceptability.
Measured: 9 months
Appropriateness - Qualitative report
Implementation success of the program measured by a semi-structured qualitative interview method which addresses appropriateness.
Measured: 9 months
Implementation Success - Quantitative report
Twelve psychometrically validated items to assess program implementation success, will be administered after training. Providers will rate items with responses using a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5).
Measured: 9 months
Secondary outcomes (3)
Knowledge
Knowledge quiz scores before and after training, 0-20, where 20 indicates higher knowledge.
Measured: 9 months
Fidelity
Self-reported use of HELP Pain strategies with students via online survey.
Measured: 9 months, 2 years
Self-report Knowledge
Self-reported agreeableness using a 5-point Likert scale from strongly disagree (1) to strongly agree (5) to 3 statements indicating knowledge from the program.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start25 Aug 2022
- Primary completion1 Jul 2024
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
- Investigators
- Natoshia R Cunningham, Ph.D., Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698290
- Sponsor's protocol ID
- STUDY00007400
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging School Providers to Manage Student Pain in Michigan Schools
- ClinicalTrials.gov ID
- NCT05698290
- Acronym / sponsor ID
- STUDY00007400
- Conditions
- Pain
- Keywords
- Pain, Cognitive Behavioral Therapy, School Providers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Jan 2023 (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.
The aim of this project is to develop and test the Helping Educators Learn Pediatric Pain Assessment \& Intervention Needs (HELP Pain) program. HELP Pain provides training for school providers (e.g., school nurses, mental health professionals) on strategies to assess and manage pain-related concerns in school children. Participants will learn cognitive behavioral therapy techniques to help school children manage pain, and report on their use of strategies, and child's progress throughout the school year. Follow-up data will be collected in year 2.
Detailed description
Chronic pain is common among school children, and impacts social, emotional and academic functioning. School providers are often tasked with addressing student pain, but may have limited training in evidence-based pain management strategies. Thus, the PI developed a training program, HELP Pain, to train school providers, such as school nurses and mental health professionals, in cognitive behavioral therapy strategies for addressing student pain. In this study, the feasibility and acceptability of the training program will be evaluated. Provider knowledge will be evaluated before and after receiving the HELP Pain training. Further, the use of HELP Pain strategies with students and their associated disability and pain outcomes will be evaluated. Results will help to tailor the HELP Pain training program for future use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Department of Northwest Michigan | – | Other: HELP Pain Training ProgramSchool providers (school nurses, mental health specialists) from the Health Department of Northwest Michigan. |
| Michigan Association of School Nurses | – | Other: HELP Pain Training ProgramSchool providers (nurses) from the Michigan Association of School Nurses. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Providers (nurses and mental health professionals) serving Michigan schools.
Key inclusion criteria (1 listed)
- engaged as a school provider in Michigan
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HELP Pain Training ProgramA training program to teach school providers nonpharmacologic (e.g., cognitive behavioral and mindfulness meditation) strategies to use with students with pain symptoms. | Other | Health Department of Northwest Michigan, Michigan Association of School Nurses |
Primary outcome
Feasibility - Qualitative report
Time frame: 9 months
Implementation success of the program measured by a semi-structured qualitative interview method which addresses feasibility.
Acceptability - Qualitative report
Time frame: 9 months
Implementation success of the program measured by a semi-structured qualitative interview method which addresses acceptability.
Appropriateness - Qualitative report
Time frame: 9 months
Implementation success of the program measured by a semi-structured qualitative interview method which addresses appropriateness.
Implementation Success - Quantitative report
Time frame: 9 months
Twelve psychometrically validated items to assess program implementation success, will be administered after training. Providers will rate items with responses using a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5).
3 secondary outcomes
Knowledge
Time frame: 9 months
Fidelity
Time frame: 9 months, 2 years
Self-report Knowledge
Time frame: 9 months
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 13 Apr 2026.
Related trials for Pain
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
RecruitingPhase 4
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Opioid Use, Fractures, Bone
Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
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. This study is not recruiting at the moment.
Natoshia R Cunningham, Ph.D. principal investigator
Michigan State University
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 Pain, run by Michigan State University at 1 site in United States.
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 1 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 13 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 States. 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?
Feasibility - Qualitative report (time frame: 9 months). The study lists 4 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 13 Apr 2026.