Clinical trial NCT05490654: Abdominal Massage for People With Learning Disabilities and Constipation
Official title: Tailored Abdominal Massage Treatment for Constipation in Adults With Learning Disabilities- A Feasibility Study and Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: Baily Thomas Charitable Fund
name: NHS Greater Glasgow and Clyde
First posted: 2022-08-08
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre feasibility randomised controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

1. A history of malignant bowel obstructions or abdominal growth
2. A history of inflammatory bowel disease of the intestine e.g. Chron's disease
3. Unstable spinal surgery
4. Recent scarring or abdominal surgery
5. Abdominal skin lesions
6. Abdominal hernia
7. Pregnancy
8. Indwelling catheter
9. Increased sensitivity to touch
10. Has undertaken Abdominal Massage within the last 3 months.

Primary outcomes:
measure: Feasibility of the abdominal massage intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Knowles-Eccersley-Scott Symptom Score (KESS)
timeFrame: 6 weeks
measure: 7 Day Bowel Diary (Non-validated scoring tool)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
state: Strathclyde
Study officials:
References: