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

NCT ID: NCT03992976

Last Updated: 2020-03-25

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-12

Study Completion Date

2021-03-01

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Anna L Hurley-Wallace, MSc

Role: CONTACT

07906352640 ext. 24719

Christina Liossi, DPsych

Role: CONTACT

02380594645 ext. 24645

Facility Contacts

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Christina Liossi, DPsych

Role: primary

02380594645

Daniel E Schoth, PhD

Role: backup

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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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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