Abdominal Massage for People With Learning Disabilities and Constipation

NCT ID: NCT05490654

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2024-03-22

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abdominal Massage

Study participants who will receive abdominal massage by manual or device delivered for 6 weeks

Group Type: EXPERIMENTAL

Abdominal Massage

Intervention Type: PROCEDURE

Abdominal Massage delivered by manual method or by Mowoot device

Control

Participants who will have no change to their normal treatment regime

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Abdominal Massage

Abdominal Massage delivered by manual method or by Mowoot device

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baily Thomas Charitable Fund

UNKNOWN

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

Glasgow Caledonian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NHS Greater Glasgow & Clyde

Glasgow, Strathclyde, United Kingdom

Countries

United Kingdom

Other Identifiers

307439

Identifier Type: -

Identifier Source: org_study_id