Development of an Online Program to Help Manage Chronic Pain in Children and Teenagers
NCT ID: NCT03992976
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2019-12-12
2021-03-01
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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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.
Online Chronic Pain Management Intervention for Teenagers
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.
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.
Online Chronic Pain Management Intervention for Teenagers
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.
Interventions
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Online Chronic Pain Management Intervention for Teenagers
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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).
12 Years
17 Years
ALL
No
Sponsors
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Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
University of Southampton
OTHER
Responsible Party
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Principal Investigators
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Christina Liossi, DPsych
Role: PRINCIPAL_INVESTIGATOR
University of Southampton, Great Ormond Street Hospital
Locations
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University of Southampton
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Related Links
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Great Ormond Street Pain Control Service
Other Identifiers
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19BO01
Identifier Type: OTHER
Identifier Source: secondary_id
45429
Identifier Type: -
Identifier Source: org_study_id
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