University College Hospital
London, NW1 2BU, United Kingdom
Completed
NCT Number: NCT02222064
Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain
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?
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- >18 years, pain experienced
- >3 months, proficiency in English
Exclusion criteria
- previous mindfulness experience
- severe cognitive impairment
- profound hearing difficulties
Treatment and study plan
Mindfulness
BehavioralMindfulness 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.
Primary outcomes
-
Change in pain distress rating on 11 point numerical rating scale
Time frame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
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"
Secondary outcomes
-
Hospital Anxiety and Depression Scale
Time frame: At baseline, week 8
-
Pain Self Efficacy Questionnaire
Time frame: At baseline, week 8
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"
-
Chronic Pain Acceptance Questionnaire
Time frame: At baseline, week 8
a 20 item measure included to provide a rating of acceptance of pain
-
Five Facet Mindfulness Questionnaire
Time frame: At baseline, week 8
a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis
-
Self-report record of using mindfulness exercises (frequency and duration)
Time frame: 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
Time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
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
-
Change in pain intensity rating on 11 point numerical rating scale
Time frame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
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"
Sponsors and collaborators
Lead sponsor
University College, London
Other
Registry information
Official study title
Exploratory Study of Mindfulness for Inpatients With Chronic Gastrointestinal Pain: Does it Reduce Pain Related Distress and Increase Confidence in Pain Self-management?
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Aug 21, 2014
- Registry last updated
- Dec 4, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.