Gastro-intestinal Pain Clinical Trial
Official title:
Exploratory Study of Mindfulness for Inpatients With Chronic Gastrointestinal Pain: Does it Reduce Pain Related Distress and Increase Confidence in Pain Self-management?
| Verified date | May 2015 |
| Source | University College, London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: National Health Service |
| Study type | Interventional |
Research questions/hypotheses
1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients
reduce pain-related distress, improve quality of life, and increase confidence in pain
self-management?
2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness
methods?
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | September 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - >18 years, pain experienced - >3 months, proficiency in English Exclusion Criteria: - previous mindfulness experience - severe cognitive impairment - profound hearing difficulties |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University College Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| University College, London |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in pain distress rating on 11 point numerical rating scale | A numerical rating scale scored from 0 to 10 which asks "how distressing is the pain on average in the last week with 0 being not distressing at all and 10 being extreme distress" | Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8 | No |
| Secondary | Hospital Anxiety and Depression Scale | At baseline, week 8 | No | |
| Secondary | Pain Self Efficacy Questionnaire | a 10 item scale that attempts to capture a measure of individual's confidence in being active despite pain, rated on a numerical scale from 0 "not at all confident" to 6 "completely confident" | At baseline, week 8 | No |
| Secondary | Chronic Pain Acceptance Questionnaire | a 20 item measure included to provide a rating of acceptance of pain | At baseline, week 8 | No |
| Secondary | Five Facet Mindfulness Questionnaire | a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis | At baseline, week 8 | No |
| Secondary | Self-report record of using mindfulness exercises (frequency and duration) | Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8 | No | |
| Secondary | Brief account of experience of pain and doing the mindfulness exercises | participants will be asked to write a brief (<1 page) account of their experience of their pain and of doing the mindfulness exercises over the preceding week | Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8 | No |
| Secondary | Change in pain intensity rating on 11 point numerical rating scale | A numerical rating scale scored from 0 to 10 which asks "how intense is the pain on average in the last week with 0 being no pain and 10 being extreme pain" | Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8 | No |