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Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02222064
Enrollment
15
Registered
2014-08-21
Start date
2014-08-31
Completion date
2015-09-30
Last updated
2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-intestinal Pain

Brief summary

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?

Interventions

BEHAVIORALMindfulness

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.

Sponsors

University College, London
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>18 years, pain experienced * \>3 months, proficiency in English

Exclusion criteria

* previous mindfulness experience * severe cognitive impairment * profound hearing difficulties

Design outcomes

Primary

MeasureTime frameDescription
Change in pain distress rating on 11 point numerical rating scaleBaseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8A 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

MeasureTime frameDescription
Hospital Anxiety and Depression ScaleAt baseline, week 8
Chronic Pain Acceptance QuestionnaireAt baseline, week 8a 20 item measure included to provide a rating of acceptance of pain
Five Facet Mindfulness QuestionnaireAt baseline, week 8a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis
Pain Self Efficacy QuestionnaireAt baseline, week 8a 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
Brief account of experience of pain and doing the mindfulness exercisesWeek 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8participants 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 scaleBaseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8A 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
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026