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

Primary Purpose

Constipation

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Abdominal Massage
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NHS Greater Glasgow & Clyde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Abdominal Massage

Control

Arm Description

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

Participants who will have no change to their normal treatment regime

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 26, 2022
Last Updated
August 29, 2023
Sponsor
Glasgow Caledonian University
Collaborators
Baily Thomas Charitable Fund, NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT05490654
Brief Title
Abdominal Massage for People With Learning Disabilities and Constipation
Acronym
AMID
Official Title
Tailored Abdominal Massage Treatment for Constipation in Adults With Learning Disabilities- A Feasibility Study and Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
August 21, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glasgow Caledonian University
Collaborators
Baily Thomas Charitable Fund, NHS Greater Glasgow and Clyde

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-centre feasibility randomised controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abdominal Massage
Arm Type
Experimental
Arm Description
Study participants who will receive abdominal massage by manual or device delivered for 6 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants who will have no change to their normal treatment regime
Intervention Type
Procedure
Intervention Name(s)
Abdominal Massage
Intervention Description
Abdominal Massage delivered by manual method or by Mowoot device
Primary Outcome Measure Information:
Title
Feasibility of the abdominal massage intervention
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Knowles-Eccersley-Scott Symptom Score (KESS)
Description
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.
Time Frame
6 weeks
Title
7 Day Bowel Diary (Non-validated scoring tool)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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: 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.
Facility Information:
Facility Name
NHS Greater Glasgow & Clyde
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G12 0XH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Any request for participant data can be made to Dr Kirsteen Goodman

Learn more about this trial

Abdominal Massage for People With Learning Disabilities and Constipation

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