PedPainSleep: Sleep, Pain and Stress in Adolescents With Persistent Pain

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677412

Collaborator

University of Helsinki (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic Sleep	Behavioral: suggestive relaxation Behavioral: Neutral story	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Experimental within-subject study designExperimental within-subject study design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sleep, Pain and Stress in Adolescents With Persistent Pain

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: neutral story Neutral story before the sleep onset	Behavioral: Neutral story neutral story before sleep
Experimental: suggestive story Suggestive story to find out the effect of relaxation to sleep structures.	Behavioral: suggestive relaxation suggestive story before sleep onset

Arm

Intervention/Treatment

Active Comparator: neutral story

Neutral story before the sleep onset

Behavioral: Neutral story

neutral story before sleep

Experimental: suggestive story

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

Behavioral: suggestive relaxation

suggestive story before sleep onset

Outcome Measures

Primary Outcome Measures

Sleep quality [one night]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Helsinki University Central Hospital
University of Helsinki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reetta Sipilä, Head of research, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT05677412

Other Study ID Numbers:

ULSHelsinki

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Jan 10, 2023