ConstipationAMIDNCT05490654
Abdominal Massage for People With Learning Disabilities and Constipation
A study testing Abdominal Massage in people with Constipation, run by Glasgow Caledonian University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Abdominal Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2022to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy
- Indwelling catheter
- Increased sensitivity to touch
- Has undertaken Abdominal Massage within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Greater Glasgow & Clyde
Glasgow, Strathclyde, G12 0XH
About this study
Official title: 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.
Read more
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.
- Conditions
- Constipation
- Being tested
- Abdominal Massage
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MassageProcedure or surgery
Abdominal Massage delivered by manual method or by Mowoot device
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage | Experimental | Study participants who will receive abdominal massage by manual or device delivered for 6 weeks Receives: Procedure: Abdominal Massage |
| Control | No intervention | Participants who will have no change to their normal treatment regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start14 Jun 2022
- Primary completion21 Aug 2023
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre feasibility randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Baily Thomas Charitable Fund, NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490654
- Sponsor's protocol ID
- 307439
- Acronym
- AMID
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any request for participant data can be made to Dr Kirsteen Goodman
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Abdominal Massage Treatment for Constipation in Adults With Learning Disabilities- A Feasibility Study and Pilot Trial
- ClinicalTrials.gov ID
- NCT05490654
- Acronym / sponsor ID
- AMID / 307439
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- Baily Thomas Charitable Fund, NHS Greater Glasgow and Clyde
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre feasibility randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage | Experimental | Procedure: Abdominal MassageStudy participants who will receive abdominal massage by manual or device delivered for 6 weeks |
| Control | No intervention | –Participants who will have no change to their normal treatment regime |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal MassageAbdominal Massage delivered by manual method or by Mowoot device | Procedure or surgery | Abdominal Massage |
Primary outcome
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.
2 secondary outcomes
Knowles-Eccersley-Scott Symptom Score (KESS)
Time frame: 6 weeks
7 Day Bowel Diary (Non-validated scoring tool)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No. Any request for participant data can be made to Dr Kirsteen Goodman
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Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Massage in people with Constipation, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the abdominal massage intervention (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.