NCT04171869

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

May 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

November 14, 2019

Last Update Submit

September 30, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Highly Sensitive Child Scale

    Sensory Processing Sensitivity

    through study completion, an average of 6 months

  • Functional Disability Inventory for children

    Physical functioning and disability in children with chronic pain

    through study completion, an average of 6 months

Interventions

observational study, no intervention

Eligibility Criteria

Age17 Years - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Adolescents suffering from persistent or recurrent pain for 3 or more months, community sample, recruited mainly via pain clinics

You may qualify if:

  • Adolescents aged 17-19 years
  • Persistent or recurrent pain for 3 months or more
  • Fluent in German or English

You may not qualify if:

  • Younger than 17 or older than 19 years
  • Acute pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology, University of Basel

Basel, 40555, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Helen Koechlin, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct senior researcher

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 21, 2019

Study Start

May 8, 2020

Primary Completion

August 15, 2020

Study Completion

September 30, 2020

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations