Chronic PainNCT04171869
Survey on Sensory Processing Sensitivity in Chronic Pediatric Pain
An observational study of Chronic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. Read more about this study
- Who is it for?
- Ages 17 to 19 years
- Conditions the study is for
- Chronic Pain
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 May 2020to 30 Sep 2020
- 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 17 to 19 years
- All sexes
- Child, Adult
Study population: Adolescents suffering from persistent or recurrent pain for 3 or more months, community sample, recruited mainly via pain clinics
Who may be able to join
- Adolescents aged 17-19 years
- Persistent or recurrent pain for 3 months or more
- Fluent in German or English
Who cannot join
- Younger than 17 or older than 19 years
- Acute pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards a Deeper Understanding of Chronic Pediatric Pain: Exploring the Role of Sensory Processing Sensitivity
Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has been proposed to underlie increased pain sensitivity is central sensitization, i.e., increased efficacy of the nervous system in transmitting pain signals, which manifests itself as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk factor for the development of chronic pain. Being more sensitive to pain is one feature commonly shared by those with high sensory processing sensitivity (SPS), who are thought to react more strongly to both positive and negative environmental influences. The relationship between this increased sensitivity and pain tolerance has not been studied to date, but could contribute to our understanding of why some children and adolescents are more vulnerable to developing chronic pain than others.
Objectives and Aims: The aim of this project is to increase scientific understanding of 1) the distribution and correlates of high SPS among children and adolescents suffering from chronic pain, and 2) whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain.
Methods: To determine the distribution (aim 1a) and correlates (aim 1b) of SPS among a population of children and adolescents suffering from chronic pain, an online survey will be conducted. Participants will be asked to complete questionnaires about their SPS as well as pain history and pain characteristics. The distribution of SPS will then be compared to an existing distribution in a sample of healthy children and adolescents.
- Conditions
- Chronic Pain
- Being tested
- no intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Highly Sensitive Child Scale
Sensory Processing Sensitivity
Measured: through study completion, an average of 6 months
Functional Disability Inventory for children
Physical functioning and disability in children with chronic pain
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start8 May 2020
- Primary completion15 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Koechlin, University Hospital, Basel, Switzerland
- Investigators
- Helen Koechlin, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171869
- Sponsor's protocol ID
- Sensory Processing Sensitivity
- Status last verified
- Sep 2020
- First submitted
- 14 Nov 2019
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Deeper Understanding of Chronic Pediatric Pain: Exploring the Role of Sensory Processing Sensitivity
- ClinicalTrials.gov ID
- NCT04171869
- Acronym / sponsor ID
- Sensory Processing Sensitivity
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 21 Nov 2019 (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.
Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has been proposed to underlie increased pain sensitivity is central sensitization, i.e., increased efficacy of the nervous system in transmitting pain signals, which manifests itself as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk factor for the development of chronic pain. Being more sensitive to pain is one feature commonly shared by those with high sensory processing sensitivity (SPS), who are thought to react more strongly to both positive and negative environmental influences. The relationship between this increased sensitivity and pain tolerance has not been studied to date, but could contribute to our understanding of why some children and adolescents are more vulnerable to developing chronic pain than others.
Objectives and Aims: The aim of this project is to increase scientific understanding of 1) the distribution and correlates of high SPS among children and adolescents suffering from chronic pain, and 2) whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain.
Methods: To determine the distribution (aim 1a) and correlates (aim 1b) of SPS among a population of children and adolescents suffering from chronic pain, an online survey will be conducted. Participants will be asked to complete questionnaires about their SPS as well as pain history and pain characteristics. The distribution of SPS will then be compared to an existing distribution in a sample of healthy children and adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents suffering from persistent or recurrent pain for 3 or more months, community sample, recruited mainly via pain clinics
Key inclusion criteria (3 listed)
- Adolescents aged 17-19 years
- Persistent or recurrent pain for 3 months or more
- Fluent in German or English
Key exclusion criteria (2 listed)
- Younger than 17 or older than 19 years
- Acute pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational study, no intervention | Other | – |
Primary outcome
Highly Sensitive Child Scale
Time frame: through study completion, an average of 6 months
Sensory Processing Sensitivity
Functional Disability Inventory for children
Time frame: through study completion, an average of 6 months
Physical functioning and disability in children with chronic pain
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 1 Oct 2020.
- Individual participant dataSharing planned: Yes
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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.
Helen Koechlin, PhD principal investigator
University Hospital, Basel, Switzerland
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 Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 2 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 1 Oct 2020. 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 Switzerland. 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?
Highly Sensitive Child Scale (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2020.