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Sleep, Pain and Stress in Adolescents With Persistent Pain (PedPainSleep)

Primary Purpose

Pain, Chronic, Sleep

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
suggestive relaxation
Neutral story
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

15 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 15-17 years with persistent (> 3months) pain reporting average pain intensity over 3/10 on the Numerical Rating Scale (NRS). Exclusion Criteria: ongoing medication for sleep or pain.

Sites / Locations

  • New Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

neutral story

suggestive story

Arm Description

Neutral story before the sleep onset

Suggestive story to find out the effect of relaxation to sleep structures.

Outcomes

Primary Outcome Measures

Sleep quality
The overnight PSG (Somnomedics) is used to measure sleep during two nights (Somnomedics, Somnoscreen plus HD), with the following recorded parameters: electroencephalography (left and right for F, C, O); left and right eletrooculogram; left and right electromyogram; electrocardiogram. Sleep recordings are done with portable devices so that the patients will sleep at their home during the recordings.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2023
Last Updated
May 23, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT05677412
Brief Title
Sleep, Pain and Stress in Adolescents With Persistent Pain
Acronym
PedPainSleep
Official Title
Sleep, Pain and Stress in Adolescents With Persistent Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim is the gain information of sleep structures in adolescents with persistent pain. Also to study simple interventions to support their sleep and pain management. The main aim of this study is to test the efficacy and feasibility of suggestive presleep relaxation technique in improving sleep quality and sleep-related emotional memory processing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Experimental within-subject study design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neutral story
Arm Type
Active Comparator
Arm Description
Neutral story before the sleep onset
Arm Title
suggestive story
Arm Type
Experimental
Arm Description
Suggestive story to find out the effect of relaxation to sleep structures.
Intervention Type
Behavioral
Intervention Name(s)
suggestive relaxation
Intervention Description
suggestive story before sleep onset
Intervention Type
Behavioral
Intervention Name(s)
Neutral story
Intervention Description
neutral story before sleep
Primary Outcome Measure Information:
Title
Sleep quality
Description
The overnight PSG (Somnomedics) is used to measure sleep during two nights (Somnomedics, Somnoscreen plus HD), with the following recorded parameters: electroencephalography (left and right for F, C, O); left and right eletrooculogram; left and right electromyogram; electrocardiogram. Sleep recordings are done with portable devices so that the patients will sleep at their home during the recordings.
Time Frame
one night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 15-17 years with persistent (> 3months) pain reporting average pain intensity over 3/10 on the Numerical Rating Scale (NRS). Exclusion Criteria: ongoing medication for sleep or pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reetta M Sipilä, PhD
Phone
+358406812427
Email
reetta.sipila@hus.fi
Facility Information:
Facility Name
New Childrens Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reetta M Sipilä, PhD
Phone
+358406812427
Email
reetta.sipila@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sleep, Pain and Stress in Adolescents With Persistent Pain

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