Abdominal massage for people with constipation: experiences, effects and cost effectiveness
| ISRCTN | ISRCTN64345887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64345887 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/08/2008
- Registration date
- 21/11/2008
- Last edited
- 21/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Catrine Jacobsson
Scientific
Scientific
Department of Nursing
Umeå University
Umeå
SE-901 87
Sweden
| Phone | +46 9 07 86 9162 |
|---|---|
| catrine.jacobsson@nurs.umu.se |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The hypothesis is that abdominal massage for people with constipation could decrease the severity of gastrointestinal symptoms, time to defecate, and laxative use, increase number of bowel movements and quantity of faeces, normalise faeces consistency without increased fluid and fibre intake or increased physical activity. The hypothesis is also that abdominal massage will increase health related quality of life and will be a cost effective intervention. |
| Ethics approval(s) | Ethics Committee at the Medical Faculty, Umeå University. Date of approval: 09/02/2005 (ref: Um dnr. 04-132M) |
| Health condition(s) or problem(s) studied | Constipation |
| Intervention | Age range of the recruited participants: from 36 to 85 years. The participants in the intervention group had 15 minutes of massage 5 days/week for 8 weeks. The duration of massage and number of assessments were based on experiences from a pilot study and recommendations from experts with experiences with gastroenterological studies. The massage consisted of very gentle strokes with light pressure. The hands and abdomen were massaged (8 and 7 minutes respectively) using a systematic movement pattern to stimulate tactile receptors in the skin. As the effect of the massage was assumed to be different between participants, the use of laxatives was adjusted based on clinical evaluation. In the control group, the participants continued with the therapy they were using when they joined the study: bulking agents, osmotic laxative, stimulant laxative, enemas, herbal supplements, or increased fibre intake. Except for a first and a concluding appointment, the contact with the control group during the study consisted of letters with questionnaires. |
| Intervention type | Other |
| Primary outcome measure | 1. Severity of gastrointestinal symptom measured with Gastrointestinal Symptom Rating Scale 2. Laxative use 3. Health related quality of life measured with EQ-5D 4. Experience of being constipated and having abdominal massage 5. Cost effectiveness of the intervention 6. Participants' experiences of having abdominal massage. Data was collected by interviews. The assessments were performed on three occasions: at baseline, Week 4 and 8. |
| Secondary outcome measures | 1. Time to defecate 2. Number of bowel movements 3. Quantity of faeces 4. Faeces consistency 5. Fluid and fibre intake 6. Physical activity The secondary outcomes were self reported in protocols Monday to Friday at baseline, Week 4 and 8. |
| Overall study start date | 24/01/2005 |
| Completion date | 26/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Adults (both males and females) who are constipated, in accordance with Rome II criteria or dependent on laxatives to have sufficient bowel movements 2. Ability to understand and express themselves in Swedish |
| Key exclusion criteria | 1. Diagnosis of dementia 2. Psychiatric disease 3. Abdominal hernia 4. Known intestinal cancer 5. Recently undergone surgical operation in the abdomen |
| Date of first enrolment | 24/01/2005 |
| Date of final enrolment | 26/03/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Nursing
Umeå
SE-901 87
Sweden
SE-901 87
Sweden
Sponsor information
Swedish Research Council (Sweden)
Research council
Research council
-
Stockholm
SE-103 78
Sweden
| Website | http://www.vr.se/2.69f66a93108e85f68d480000.html |
|---|---|
"ROR" |
https://ror.org/03zttf063 |
Funders
Funder type
Research council
Swedish Research Council (Sweden) (Grant ref: K2006-27X-20063-01-3)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Swedish Association of Health Professionals (Sweden)
No information available
Ekhaga Foundation (Sweden) (Grant ref: 2006-16)
No information available
County Council of Västerbotten (Sweden) (Grant ref: VLL 1178:3 2006)
No information available
Senior Centre of Västerbotten (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
