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Completed

NCT Number: NCT05490654

Abdominal Massage for People With Learning Disabilities and Constipation

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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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Greater Glasgow & Clyde

Glasgow, Strathclyde, G12 0XH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Abdominal Massage

Procedure

Abdominal Massage delivered by manual method or by Mowoot device

Primary outcomes

  1. Feasibility of the abdominal massage intervention

    Time frame: 6 weeks

    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 outcomes

  1. Knowles-Eccersley-Scott Symptom Score (KESS)

    Time frame: 6 weeks

    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.

  2. 7 Day Bowel Diary (Non-validated scoring tool)

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Collaborators

  • Baily Thomas Charitable Fund
  • NHS Greater Glasgow and Clyde

Registry information

Official study title

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

Acronym: AMID

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 8, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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