Abdominal Massage for People With Learning Disabilities and Constipation

Study Overview
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Brief Summary
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Background and study aims: Constipation, which is difficulty going to the toilet to do a 'poo' is common in adults with learning disabilities (LD), but there is not a lot of knowledge (information) about the best way to help treat constipation experienced by adults with learning disabilities. Adults with learning disabilities who have constipation should be assessed and treated. There is knowledge to suggest that abdominal massage may help some people with constipation so that people with constipation can go to the toilet more easily. There is also knowledge to suggest that the use of a device to do the massage may be as beneficial as getting a carer to do it for the participant. This research wants to invite 40 adults with learning disabilities with constipation to take part. 30 will be offered the abdominal massage, either by a carer or the device, and 10 will not be offered the massage. However, the participants will be shown how to do it at the end of the study. This research wants to find out if people with LD are willing to take part in such a study and if the participants are more willing to let a carer do the massage, or would rather use the device. It is also important that the investigators know if the participants who are in the group not getting the massage are willing to continue in the research. Taking part for 6 weeks will provide the investigators with this important information before the investigators undertake a much larger study which the investigators need to do to find out if it helps with constipation.

Official Title
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Tailored Abdominal Massage Treatment for Constipation in Adults With Learning Disabilities- A Feasibility Study and Pilot Trial

Conditions
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Constipation

Intervention / Treatment
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* Procedure: Abdominal Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. A person with a Learning Disability who is known to suffer from constipation including: 1a-those on long term laxatives but still prone to constipation 1b- those who have been admitted to hospital due to impaction 1c- those who use enemas regularly but still have emptying problems. Exclusion Criteria: A history of malignant bowel obstructions or abdominal growth A history of inflammatory bowel disease of the intestine e.g. Chron's disease Unstable spinal surgery Recent scarring or abdominal surgery Abdominal skin lesions Abdominal hernia Pregnancy Indwelling catheter Increased sensitivity to touch Has undertaken Abdominal Massage within the last 3 months.

Ages Eligible for Study
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Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre feasibility randomised controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal Massage<br>Study participants who will receive abdominal massage by manual or device delivered for 6 weeks | Procedure: Abdominal Massage<br>* Abdominal Massage delivered by manual method or by Mowoot device<br>|
| No Intervention: Control<br>Participants who will have no change to their normal treatment regime | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the abdominal massage intervention | Feasibility Questionnaire (Non- validated) to determine the acceptability of the intervention. Content analysis of free text and scoring of 0-5 Likert scale for level of confidence for posed questions with 5 being highly confident and 0 having no confidence. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowles-Eccersley-Scott Symptom Score (KESS) | The Knowles-Eccersley-Scott Symptom Score will assess degree and impact of constipation and be completed before and after the intervention. 11 scored questions with score values of Minimum 1 and maximum of 5. The higher score indicates the higher degree of severity. | 6 weeks | 
| 7 Day Bowel Diary (Non-validated scoring tool) | 7 day Bowel Diary completed before and after the intervention. Scoring indicates the frequency of stools per day for 7 days with the higher number indicating a better outcome. | 6 weeks |