Sleep, Pain and Stress in Adolescents With Persistent Pain

Sleep Clinical Trial

— PedPainSleep  

Official title:

Sleep, Pain and Stress in Adolescents With Persistent Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677412
• Other study ID #: ULSHelsinki
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: Helsinki University Central Hospital
• Contact: Reetta M Sipilä, PhD
• Phone: +358406812427
• Email: reetta.sipila[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Sleep

Intervention

Behavioral:
• suggestive relaxation
suggestive story before sleep onset
• Neutral story
neutral story before sleep

Locations

Country	Name	City	State
Finland	New Childrens Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one night