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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03992976
• Other study ID #: 45429
• Secondary ID: 19BO01
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2020
• Source: University of Southampton
• Contact: Anna L Hurley-Wallace, MSc
• Phone: 07906352640
• Email: A.Hurley-Wallace[@]soton.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Southampton	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
University of Southampton	Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 1 hour

External Links

•   Great Ormond Street Pain Control Service