Clinical trial NCT03992976: Development of an Online Program to Help Manage Chronic Pain in Children and Teenagers
Official title: Development of an Online, Interdisciplinary Intervention for Paediatric Chronic Pain Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Chronic Pain
Paediatric Pain
Pain Management
Qualitative Research
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
First posted: 2019-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care pain clinic, community sample

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.

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).

Primary outcomes:
measure: 8-item interview schedule
timeFrame: approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
Study officials:
affiliation: University of Southampton, Great Ormond Street Hospital
name: Christina Liossi, DPsych
role: PRINCIPAL_INVESTIGATOR
References: