Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain

Study Overview
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Brief Summary
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Research questions/hypotheses 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? How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness methods?

Official Title
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Exploratory Study of Mindfulness for Inpatients With Chronic Gastrointestinal Pain: Does it Reduce Pain Related Distress and Increase Confidence in Pain Self-management?

Conditions
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Gastro-intestinal Pain

Intervention / Treatment
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* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years, pain experienced >3 months, proficiency in English Exclusion Criteria: previous mindfulness experience severe cognitive impairment profound hearing difficulties

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>8 week self-managed mindfulness based intervention | Behavioral: Mindfulness<br>* Mindfulness is a psychological intervention based on increasing skills of non-judgemental awareness using meditations. In this study a self-directed 8 week course of mindfulness will be used involving self-help materials in the form of a book and 8 guided meditations on audio files.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale |  | At baseline, week 8 | 
| 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 | 
| Chronic Pain Acceptance Questionnaire | a 20 item measure included to provide a rating of acceptance of pain | At baseline, week 8 | 
| Five Facet Mindfulness Questionnaire | a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis | At baseline, week 8 | 
| 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 | 
| 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 | 
| 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 |