Abdominal Massage for People With Learning Disabilities and Constipation

NCT05490654 | Completed

• 1 other identifier: 307439
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Knowles-Eccersley-Scott Symptom Score (KESS)

  6 weeks

• 7 Day Bowel Diary (Non-validated scoring tool)

  6 weeks

Study Arms (2)

Abdominal Massage

EXPERIMENTAL

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

Procedure: Abdominal Massage

Control

NO INTERVENTION

Participants who will have no change to their normal treatment regime

Interventions

Abdominal Massage PROCEDURE

Abdominal Massage delivered by manual method or by Mowoot device

Abdominal Massage

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. A person with a Learning Disability who is known to suffer from constipation including:
• a-those on long term laxatives but still prone to constipation
• b- those who have been admitted to hospital due to impaction
• c- those who use enemas regularly but still have emptying problems.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• Baily Thomas Charitable Fund: collaborator
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

NHS Greater Glasgow & Clyde

Glasgow, Strathclyde, G12 0XH, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre feasibility randomised controlled trial.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 8, 2022
• Study Start: June 14, 2022
• Primary Completion: August 21, 2023
• Study Completion: March 22, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)