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Clinical Trials/NCT05677412
NCT05677412RecruitingNot Applicable

Sleep, Pain and Stress in Adolescents With Persistent Pain

Helsinki University Central Hospital1 site in 1 country20 target enrollmentStarted: May 23, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Sleep quality

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

neutral story

Active Comparator

Neutral story before the sleep onset

Intervention: Neutral story (Behavioral)

suggestive story

Experimental

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

Intervention: suggestive relaxation (Behavioral)

Outcomes

Primary Outcomes

Sleep quality

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reetta Sipilä

Head of research

Helsinki University Central Hospital

Study Sites (1)

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