Abdominal Massage for People With Learning Disabilities and Constipation

Constipation Clinical Trial

— AMID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05490654
• Other study ID #: 307439
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Learning Disabilities

Intervention

Procedure:
• Abdominal Massage
Abdominal Massage delivered by manual method or by Mowoot device

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow & Clyde	Glasgow	Strathclyde

Sponsors (3)

Lead Sponsor	Collaborator
Glasgow Caledonian University	Baily Thomas Charitable Fund, NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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