Development of an Online Program to Help Manage Chronic Pain in Children and Teenagers

March 24, 2020 updated by: University of Southampton

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Secondary care pain clinic, community sample

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Collaborators

Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

  • Principal Investigator: Christina Liossi, DPsych, University of Southampton, Great Ormond Street Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 12, 2019

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (ACTUAL)

June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45429
  • 19BO01 (OTHER: Great Ormond Street Hospital for Children NHS Foundation Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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