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CompletedNCT05490654AMIDUpdated Aug 15, 2024

Abdominal Massage for People With Learning Disabilities and Constipation

An interventional study of Abdominal Massage in Constipation, sponsored by Glasgow Caledonian University. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Glasgow Caledonian University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
16 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Constipation

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03

In context

Constipation

1,041 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 31 is below the median of 78 across 867 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Glasgow Caledonian University is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Abdominal Massage

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

    Procedure: Abdominal Massage

  • No intervention
    Control

    Participants who will have no change to their normal treatment regime

Interventions

  • ProcedureAbdominal Massage

    Abdominal Massage delivered by manual method or by Mowoot device

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What researchers measure

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.

    Time frame: 6 weeks

Secondary outcomes

  1. 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.

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

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Study locations

1 site
  • NHS Greater Glasgow & Clyde
    Glasgow, Strathclyde G12 0XH, United Kingdom
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References and documents

Individual participant data

Plan to share: No — Any request for participant data can be made to Dr Kirsteen Goodman

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05490654
Lead sponsor
Glasgow Caledonian University
Collaborators
Baily Thomas Charitable Fund, NHS Greater Glasgow and Clyde
Responsible party
Sponsor
First posted
Aug 8, 2022
Start date
Jun 14, 2022
Primary completion
Aug 21, 2023
Completion
Mar 22, 2024
Last update
Aug 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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