Abdominal Massage for People With Learning Disabilities and Constipation (AMID)

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Procedure: Abdominal Massage

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom, G12 0XH
      • NHS Greater Glasgow & Clyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University
• Collaborators: NHS Greater Glasgow and Clyde; Baily Thomas Charitable Fund

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Signs and Symptoms, Digestive; Neurodevelopmental Disorders; Communication Disorders; Constipation; Learning Disabilities
• Other Study ID Numbers: 307439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Any request for participant data can be made to Dr Kirsteen Goodman

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No