Survey on Sensory Processing Sensitivity in Chronic Pedia... | NCT04171869

Studies
Survey on Sensory Processing Sensitivity in Chronic Pediatric Pain

NCT04171869

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Oct 1, 2020Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Chronic Pain

Interventions

no intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2020Actual

Primary Completion Date

Aug 15, 2020Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Nov 14, 2019

First Submission Date that Met QC Criteria

Nov 18, 2019

First Posted Date

Nov 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2020

Last Update Posted Date

Oct 1, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helen Koechlin, Adjunct senior researcher, University Hospital, Basel, SwitzerlandPrincipal Investigator

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	observational study, no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Younger than 17 or older than 19 years
Acute pain

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helen Koechlin, PhD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Psychology, University of Basel		Basel		40555	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided