NCT02969434

Brief Summary

Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy, improve both sleep quality and also pain management, and reduce interference of pain with daily activities. As effective pain relief decreases sleep disturbances, improvement in sleep has been proposed as marker of effective pain management. Hence it is useful to evaluate sleep disturbances in chronic pain population both in clinical and research setting. There are many tools to evaluate sleep quality; the routinely used simple brief pain inventory (BPI) has a single question about sleep. We will compare three dedicated sleep measures to the BPI in patients with chronic pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
Last Updated

April 21, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

November 17, 2016

Last Update Submit

April 20, 2017

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Recruitment of 50 patients

    16 weeks

Study Arms (1)

Sleep questionnaires assessment tools

EXPERIMENTAL

Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).

Other: Sleep assessment tools

Interventions

Sleep assessment toolsOTHER

Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).

Sleep questionnaires assessment tools

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 16 or over Chronic pain Fluent in English Able to report on their health and pain status (neurologically stable)

You may not qualify if:

  • Under 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen/NHS Grampian

Aberdeen, Scotland, AB25 2ZB, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saravanakumar F Kanakarajan

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

November 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 20, 2017

Last Updated

April 21, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)