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Clinical Trials/NCT03992976
NCT03992976
Unknown
Not Applicable

Development of an Online, Interdisciplinary Intervention for Paediatric Chronic Pain Management

University of Southampton1 site in 1 country60 target enrollmentDecember 12, 2019
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Southampton
Enrollment
60
Locations
1
Primary Endpoint
8-item interview schedule
Last Updated
6 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
December 12, 2019
End Date
March 1, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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.

Study Sites (1)

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