Sleep, Pain and Quality of Life in Chronic Pain Patients

Chronic Pain Clinical Trial

Official title:

Sleep, Pain and Health-related Quality of Life in Chronic Pain Patients. Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265586
• Other study ID #: HUS/577/2019
• Status: Completed
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The interventional study will have two main aims. First, to compare two interventions aiming to improve sleep in chronic pain patients. And secondly, to study the associations of sleep, mood, chronic pain and quality of life. Half of participants will go through iCBT intervention for insomnia and the other half will receive sleep hygiene education. Additionally, the study will gather information which patients will benefit/will not benefit the tertiary pain clinic treatment when the outcome variable is the Health-related Quality of Life (HrQoL).

Description:

Sleep disturbances associates closely with chronic pain. It now seems that sleep problems usually precede and maintain persistent pain. Anxiety and worry frequently precede and associate with disturbed sleep and chronic pain. Depression is usually a consequence of chronic pain. Pain and depression disturb sleep further. These elements form a vicious circle where poor sleep is a critical driver. Previous studies have shown that sleep disturbances are a major contributor to the poor health-related quality of life (HRQoL) of patients with chronic pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• fluency in Finnish

Exclusion Criteria:

• severe psychiatric conditions (e.g. scizopherenia)

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Education
Sleep hygiene education is either face-to-face appointment or "video-meeting" with trained nurse.
• Web-based Cognitive Behavioural Therapy (iCBT)
iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.

Locations

Country	Name	City	State
Finland	HUH Pain Clinic	Helsinki
Finland	Turku University Hospitla Pain Clinic	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Turku University Hospital, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life (HrQoL) questionnaire (15D)	15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL	Change from Baseline HrQoL at 12 months
Secondary	Mood -BDI-II and STAI-Y	Questionnaires about depression and anxiety, BDI-II values ranging from 0-63, and STAI-Y values ranging form 20-80 for both state and trait anxiety. Higher values in both questionnaires indicates higher amount of asked symptom.	Change from Baseline mood at 12 months
Secondary	Pain related catastrophizing (PCS)	Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency.	Change from Baseline pain related catatsrophizing at 12 months
Secondary	Stress and worrying tendency	Questionnaires about perceived stress and worrying tendency. Values ranges from 16 to 80, higher values indicating higher amount of worring tendency.	Change from Baseline stress and worrying tendency at 12 months
Secondary	Brief Pain Inventory (BPI)	12-item questionnaire abour self-reported pain intensity and interference. Values ranges from 0 to 120, higher values indicating higher amount of pain interference and intensity.	Change from Baseline pain intensity and interference at 12 months
Secondary	Insomnia Severity Index (ISI)	5-item questionnaire of self-reported symptoms of insomnia. Values ranging from 0 to 28, higher values indicating higer amount of symptoms of insomnia.	Change from Baseline symptoms of insomnia at 12 months