Chronic PainNCT04261114
Exploring the Link Between Pain and Distress in Adolescent Patients with Chronic Pain
An observational study of Chronic Pain, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The primary aim is to explore what it is about the experience of chronic pain that may cause emotional distress in some young people but not in others, and how particular individual characteristics, as well as family factors may contribute to young persons' pain experiences and their emotional responses to pain. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Chronic Pain
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2022to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 77 Adolescents with chronic pain and their parents/ caregivers
Who may be able to join
- Part 1: Adolescents
- Participant is willing and able to give assent (aged 12-15) or informed consent (aged =>16) for participation in the study
- Adolescents aged 12 to 19 years
- Self-reported experience of chronic pain (i.e., recurrent and/or persistent pain at least once per week for at least 3 months).
- Able to read and converse fluently in English
- Parent/carer willing to give informed consent for participants aged 12-15
Show all 12Show fewer
- Part 2: Adults
- Participant is willing and able to give informed consent for participation in the study.
- Participant is the parent/carer for a child aged 12 to 19 years, with chronic pain (i.e., recurrent or persistent pain at least once per week for the past 3 months), and this child is participating in this study.
- Able to read and converse fluently in English
- Additional criteria for Part 3: Follow-up part
- In possession of a smartphone to complete the momentary assessments.
Who cannot join
- Part 1: Adolescents
- If some type of serious pathology (e.g., infection, fracture, disease process (e.g., cancer)) or surgical procedure is the cause of the resulting pain complaint.
- If the patient is too psychologically unstable (e.g., experience of hallucinations or delusions, or with known acute suicide risk) to safely participate in this research, based on clinical judgment.
- Part 2: Adults
- -If the clinical care team thinks the parent/ caregiver is unsuitable for this study.
- Additional criteria for Part 3: Follow-up part
- -Inability to provide data via the use of a smartphone
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Centre for Children and Young People in Pain
Oxford, Oxfordshire
About this study
Official title: Exploring the Relationship Between Physical Pain and Emotional Distress in Adolescents with Chronic Pain - a Three-step Observational Follow-up Study
The primary aim is to explore what it is about the experience of chronic pain that may cause emotional distress in some young people but not in others, and how particular individual characteristics, as well as family factors may contribute to young persons' pain experiences and their emotional responses to pain.
Read the detailed description
This is a three-part observational follow-up study:
Part one will explore (a) whether the current sample reports emotional distress, including feelings of burdensomeness, hopelessness and thoughts and acts of self-harm, and if young people perceive there to be a link between pain and any such feelings of distress, and (b) which aspects of the pain experience, if any, are associated with such distress, using qualitative and quantitative data.
Part two will explore potential individual-level and family-level risk and resilience factors underpinning the hypothesised relationship between aspects of the pain experience and burdensomeness, hopelessness and thoughts and acts of self-harm, using adolescent and parental baseline data.
In part three, adolescent participants will be invited to complete daily diaries on their pain experience, three times per day over 7 days, in order to investigate which aspects of the pain experience are associated with burdensomeness and hopelessness at follow-up.
This study has the potential to improve the care of young people with chronic pain, and in particular the emotional support that young people receive.
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Adolescents, Emotional distress, Burdensomeness, Self-harm, Hopelessness
- Medical subject headings
- Chronic Pain, Self-Injurious Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived burdensomeness
Interpersonal Needs Questionnaire (INQ), completed by the adolescents. Scores range from 1="not at all true for me" to 7="very true for me", with higher scores indicating more perceived burdensomeness.
Measured: at baseline
Secondary outcomes (4)
Perceived burdensomeness
Interpersonal Needs Questionnaire (INQ), completed by the adolescents. Scores range from 1="not at all true for me" to 7="very true for me", with higher scores indicating more perceived burdensomeness.
Measured: at 7-day follow-up
Hopelessness
Hopelessness Scale for Children (HSC), completed by the adolescents. Participants score each item as 1=True and 0=False. The higher the score, the greater the hopelessness for the future.
Measured: at baseline
Hopelessness
Hopelessness Scale for Children (HSC), completed by the adolescents. Participants score each item as 1=True and 0=False. The higher the score, the greater the hopelessness for the future.
Measured: at 7-day follow-up
Thoughts and acts of self-harm
4 single items on the presence/ absence of self-harm thoughts and acts, completed by the adolescents.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start13 Jun 2022
- Primary completion12 Jun 2023
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oskar-Helene-Heim Foundation
- Responsible party
- Principal investigator, VerenaHinze, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261114
- Sponsor's protocol ID
- PID14553-SP001-AC001
- Status last verified
- Sep 2024
- First submitted
- 5 Feb 2020
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The syntax code and a fully de-identified version of the final dataset may be shared with third parties to support future related research where it is in the public interest.
Publications
Hinze V, Gjelsvik B, Crane C, Jacobs K. Prevalence and Correlates of Suicidal Distress in Adolescents in a Chronic Pain Service. Paediatr Neonatal Pain. 2026 Sep 30;8(4):e70046. doi: 10.1002/pne2.70046. eCollection 2026 Dec.
PubMed 42818986
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Physical Pain and Emotional Distress in Adolescents with Chronic Pain - a Three-step Observational Follow-up Study
- ClinicalTrials.gov ID
- NCT04261114
- Acronym / sponsor ID
- PID14553-SP001-AC001
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Adolescents, Emotional distress, Burdensomeness, Self-harm, Hopelessness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oskar-Helene-Heim Foundation
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to explore what it is about the experience of chronic pain that may cause emotional distress in some young people but not in others, and how particular individual characteristics, as well as family factors may contribute to young persons' pain experiences and their emotional responses to pain.
Detailed description
This is a three-part observational follow-up study:
Part one will explore (a) whether the current sample reports emotional distress, including feelings of burdensomeness, hopelessness and thoughts and acts of self-harm, and if young people perceive there to be a link between pain and any such feelings of distress, and (b) which aspects of the pain experience, if any, are associated with such distress, using qualitative and quantitative data.
Part two will explore potential individual-level and family-level risk and resilience factors underpinning the hypothesised relationship between aspects of the pain experience and burdensomeness, hopelessness and thoughts and acts of self-harm, using adolescent and parental baseline data.
In part three, adolescent participants will be invited to complete daily diaries on their pain experience, three times per day over 7 days, in order to investigate which aspects of the pain experience are associated with burdensomeness and hopelessness at follow-up.
This study has the potential to improve the care of young people with chronic pain, and in particular the emotional support that young people receive.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 77 Adolescents with chronic pain and their parents/ caregivers
Key inclusion criteria (12 listed)
- Part 1: Adolescents
- Participant is willing and able to give assent (aged 12-15) or informed consent (aged =>16) for participation in the study
- Adolescents aged 12 to 19 years
- Self-reported experience of chronic pain (i.e., recurrent and/or persistent pain at least once per week for at least 3 months).
- Able to read and converse fluently in English
Key exclusion criteria (7 listed)
- Part 1: Adolescents
- If some type of serious pathology (e.g., infection, fracture, disease process (e.g., cancer)) or surgical procedure is the cause of the resulting pain complaint.
- If the patient is too psychologically unstable (e.g., experience of hallucinations or delusions, or with known acute suicide risk) to safely participate in this research, based on clinical judgment.
- Part 2: Adults
- -If the clinical care team thinks the parent/ caregiver is unsuitable for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived burdensomeness
Time frame: at baseline
Interpersonal Needs Questionnaire (INQ), completed by the adolescents. Scores range from 1="not at all true for me" to 7="very true for me", with higher scores indicating more perceived burdensomeness.
4 secondary outcomes
Perceived burdensomeness
Time frame: at 7-day follow-up
Hopelessness
Time frame: at baseline
Hopelessness
Time frame: at 7-day follow-up
Thoughts and acts of self-harm
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 42818986Hinze V, Gjelsvik B, Crane C, Jacobs K. Prevalence and Correlates of Suicidal Distress in Adolescents in a Chronic Pain Service. Paediatr Neonatal Pain. 2026 Sep 30;8(4):e70046. doi: 10.1002/pne2.70046. eCollection 2026 Dec.
- Individual participant dataSharing planned: Undecided. The syntax code and a fully de-identified version of the final dataset may be shared with third parties to support future related research where it is in the public interest.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived burdensomeness (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.