Sleep, Pain and Stress in Adolescents With Persistent Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-17
SponsorHelsinki University Central Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 15-17 years with persistent (> 3months) pain reporting average pain intensity over 3/10 on the Numerical Rating Scale (NRS).
Disqualifiers
ongoing medication for sleep or pain.
Trial design
Design model
Crossover
Treatments tested in this trial
suggestive relaxation
Behavioralsuggestive story before sleep onset
Neutral story
Behavioralneutral story before sleep
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: neutral storyActive comparator 1 intervention
Group B: suggestive storyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
one nightSponsors and contacts
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Helsinki University Central Hospital
Lead sponsor
University of Helsinki
Collaborator
Source ClinicalTrials.gov