Chronic PainNCT03992976
Development of an Online Program to Help Manage Chronic Pain in Children and Teenagers
An observational study of Chronic Pain, run by University of Southampton at 1 site in United Kingdom.
Trial summary
This research seeks to develop an internet-based program to help teenagers manage pain at home using a variety of techniques from physiotherapy, medicine, psychology and nursing. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Online Chronic Pain Management Intervention for Teenagers
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2019to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Secondary care pain clinic, community sample
Who may be able to join
- Adolescents aged 12 to 17 years
- Adolescents experiencing chronic pain of any type (minimum duration of three months).
- Parents or legal guardians of adolescents, aged 12 to 17 years, who are experiencing chronic pain of any type (minimum duration of three months).
Who cannot join
- Unable to communicate in fluent, spoken English.
- Adolescents aged 18 years or over.
- Adolescents with chronic cancer pain that are continuing to undergo treatments to eradicate their primary cancer or have received these treatments in the last three months (maintenance therapies are acceptable).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Southampton
Southampton, SO17 1BJ
Christina Liossi, DPsych, 02380594645, c.liossi@soton.ac.uk
Daniel E Schoth, PhD, d.e.schoth@soton.ac.uk
About this study
Official title: Development of an Online, Interdisciplinary Intervention for Paediatric Chronic Pain Management
This research seeks to develop an internet-based program to help teenagers manage pain at home using a variety of techniques from physiotherapy, medicine, psychology and nursing. This study uses interviews to investigate what content and features teenagers and their parents want to see in an online intervention for managing chronic pain in teenagers.
Read the detailed description
This research seeks to develop an internet-based programme to help teenagers manage pain at home using a variety of techniques that mirror clinical practice. This includes content from medicine, physiotherapy, nursing and psychological techniques, such as relaxation.
The study will use interviews (one semi-structured interview and one 'think-aloud' interview per participant) to explore the question: What content and features do young people with chronic pain, and their parents want to see in an online pain management intervention?
The study seeks to recruit a group of teenagers from Great Ormond Street Hospital, as well as a group of parents. After the first round of interviews, participants have the option to be contacted about the second round.
Recruitment for the first round of interviews will continue up until the point where no additional insights are found by adding new data to the analysis ('point of saturation'). We anticipate 30 teenagers and 30 parents will be sufficient. We hope to recruit young people with a mixture of ages and sexes, as well as a mixture of different pain diagnoses, and parents with varying backgrounds and sexes where possible.
The insights gathered from this study will help develop a new program for managing chronic pain in teenagers, which we aim to make available through the NHS. The internet-based intervention hopes to contribute to successful chronic pain management at home, and may be used as an adjunct to clinical services, such as the Pain Control Service at Great Ormond Street Hospital.
- Conditions
- Chronic Pain
- Being tested
- Online Chronic Pain Management Intervention for Teenagers
- Keywords
- Chronic Pain, Paediatric Pain, Pain Management, Qualitative Research
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Chronic Pain Management Intervention for TeenagersOther
The intervention itself is currently under development. This development study is used to gather patient (teenager) insights, as well as insights from parents of these patients, which will inform the content and structure of the proposed intervention. This is done using qualitative-only techniques. Initial ideas for the intervention design mirror current clinical practices in paediatric chronic pain management. There are likely to be several different online modules, which include psychological techniques, medicine (advice), nursing (advice and guidance on non-pharmacological physical pain management), and physiotherapy (guidance for pacing and physiotherapy exercises). The intervention is intended to help teenagers employ a vast range of self-management techniques from these disciplines. Exact content is not yet refined as this is a development study.
| Study group | Role | What they receive |
|---|---|---|
| Teenagers with chronic pain | Semi-structured interviews followed by 'think-aloud' procedure in part two. Semi-structured interviews may last up to 1 hour and are audio-recorded. A pre-piloted interview schedule has been developed and will guide the conversation. 'Think-aloud' procedure involves showing participants some of the online content that has been developed on a computer screen, and asking them to say aloud their commentary on any aspects. Participants will be audio-recorded during the task, and it is not anticipated the task will take longer than 1 hour to complete. Each participant may only take part in one interview and one think-aloud procedure. Receives: Other: Online Chronic Pain Management Intervention for Teenagers | |
| Parents of teenagers with chronic pain | Semi-structured interviews followed by 'think-aloud' procedure in part two. Semi-structured interviews may last up to 1 hour and are audio-recorded. A pre-piloted interview schedule has been developed and will guide the conversation. 'Think-aloud' procedure involves showing participants some of the online content that has been developed on a computer screen, and asking them to say aloud their commentary on any aspects. Participants will be audio-recorded during the task, and it is not anticipated the task will take longer than 1 hour to complete. Each participant may only take part in one interview and one think-aloud procedure. Receives: Other: Online Chronic Pain Management Intervention for Teenagers |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-item interview schedule
Patient-reported outcome collected from semi-structured interviews (dynamic measure). A pre-piloted interview schedule was developed for this specific study. The schedule contains questions about online pain management interventions for adolescents. There are 8 core questions, as well as a warm-up at the start and a debrief at the end.
Measured: approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start12 Dec 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Christina Liossi, DPsych, Principal investigator, University of Southampton, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992976
- Sponsor's protocol ID
- 45429
- Other IDs
- 19BO01
- Status last verified
- Mar 2020
- First submitted
- 13 Jun 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised, transcribed data and audio-recordings will available via the University of Southampton file store for up to 10 years, in-line with university policy.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Online, Interdisciplinary Intervention for Paediatric Chronic Pain Management
- ClinicalTrials.gov ID
- NCT03992976
- Acronym / sponsor ID
- 45429
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Paediatric Pain, Pain Management, Qualitative Research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 20 Jun 2019 (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 research seeks to develop an internet-based program to help teenagers manage pain at home using a variety of techniques from physiotherapy, medicine, psychology and nursing. This study uses interviews to investigate what content and features teenagers and their parents want to see in an online intervention for managing chronic pain in teenagers.
Detailed description
This research seeks to develop an internet-based programme to help teenagers manage pain at home using a variety of techniques that mirror clinical practice. This includes content from medicine, physiotherapy, nursing and psychological techniques, such as relaxation.
The study will use interviews (one semi-structured interview and one 'think-aloud' interview per participant) to explore the question: What content and features do young people with chronic pain, and their parents want to see in an online pain management intervention?
The study seeks to recruit a group of teenagers from Great Ormond Street Hospital, as well as a group of parents. After the first round of interviews, participants have the option to be contacted about the second round.
Recruitment for the first round of interviews will continue up until the point where no additional insights are found by adding new data to the analysis ('point of saturation'). We anticipate 30 teenagers and 30 parents will be sufficient. We hope to recruit young people with a mixture of ages and sexes, as well as a mixture of different pain diagnoses, and parents with varying backgrounds and sexes where possible.
The insights gathered from this study will help develop a new program for managing chronic pain in teenagers, which we aim to make available through the NHS. The internet-based intervention hopes to contribute to successful chronic pain management at home, and may be used as an adjunct to clinical services, such as the Pain Control Service at Great Ormond Street Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teenagers with chronic pain | – | Other: Online Chronic Pain Management Intervention for TeenagersSemi-structured interviews followed by 'think-aloud' procedure in part two. Semi-structured interviews may last up to 1 hour and are audio-recorded. A pre-piloted interview schedule has been developed and will guide the conversation. 'Think-aloud' procedure involves showing participants some of the online content that has been developed on a computer screen, and asking them to say aloud their commentary on any aspects. Participants will be audio-recorded during the task, and it is not anticipated the task will take longer than 1 hour to complete. Each participant may only take part in one interview and one think-aloud procedure. |
| Parents of teenagers with chronic pain | – | Other: Online Chronic Pain Management Intervention for TeenagersSemi-structured interviews followed by 'think-aloud' procedure in part two. Semi-structured interviews may last up to 1 hour and are audio-recorded. A pre-piloted interview schedule has been developed and will guide the conversation. 'Think-aloud' procedure involves showing participants some of the online content that has been developed on a computer screen, and asking them to say aloud their commentary on any aspects. Participants will be audio-recorded during the task, and it is not anticipated the task will take longer than 1 hour to complete. Each participant may only take part in one interview and one think-aloud procedure. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Secondary care pain clinic, community sample
Key inclusion criteria (3 listed)
- Adolescents aged 12 to 17 years
- Adolescents experiencing chronic pain of any type (minimum duration of three months).
- Parents or legal guardians of adolescents, aged 12 to 17 years, who are experiencing chronic pain of any type (minimum duration of three months).
Key exclusion criteria (3 listed)
- Unable to communicate in fluent, spoken English.
- Adolescents aged 18 years or over.
- Adolescents with chronic cancer pain that are continuing to undergo treatments to eradicate their primary cancer or have received these treatments in the last three months (maintenance therapies are acceptable).
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 |
|---|---|---|
| Online Chronic Pain Management Intervention for TeenagersThe intervention itself is currently under development. This development study is used to gather patient (teenager) insights, as well as insights from parents of these patients, which will inform the content and structure of the proposed intervention. This is done using qualitative-only techniques. Initial ideas for the intervention design mirror current clinical practices in paediatric chronic pain management. There are likely to be several different online modules, which include psychological techniques, medicine (advice), nursing (advice and guidance on non-pharmacological physical pain management), and physiotherapy (guidance for pacing and physiotherapy exercises). The intervention is intended to help teenagers employ a vast range of self-management techniques from these disciplines. Exact content is not yet refined as this is a development study. | Other | Parents of teenagers with chronic pain, Teenagers with chronic pain |
Primary outcome
8-item interview schedule
Time frame: approximately 1 hour
Patient-reported outcome collected from semi-structured interviews (dynamic measure). A pre-piloted interview schedule was developed for this specific study. The schedule contains questions about online pain management interventions for adolescents. There are 8 core questions, as well as a warm-up at the start and a debrief at the end.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided. Anonymised, transcribed data and audio-recordings will available via the University of Southampton file store for up to 10 years, in-line with university policy.
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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. This study is not recruiting at the moment.
Christina Liossi, DPsych principal investigator
University of Southampton, Great Ormond Street Hospital
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 Chronic Pain, run by University of Southampton 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna L Hurley-Wallace, MSc (07906352640 ext. 24719, A.Hurley-Wallace@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-item interview schedule (time frame: approximately 1 hour). 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 25 Mar 2020.