Contact information
Type
Scientific
Primary contact
Dr Catrine Jacobsson
ORCID ID
Contact details
Department of Nursing
Umeå University
Umeå
SE-901 87
Sweden
+46 9 07 86 9162
catrine.jacobsson@nurs.umu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics Committee at the Medical Faculty, Umeå University. Date of approval: 09/02/2005 (ref: Um dnr. 04-132M)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
24/01/2005
Overall trial end date
26/03/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Diagnosis of dementia
2. Psychiatric disease
3. Abdominal hernia
4. Known intestinal cancer
5. Recently undergone surgical operation in the abdomen
Recruitment start date
24/01/2005
Recruitment end date
26/03/2007
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Nursing
Umeå
SE-901 87
Sweden
Sponsor information
Organisation
Swedish Research Council (Sweden)
Sponsor details
-
Stockholm
SE-103 78
Sweden
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Swedish Research Council (Sweden) (Grant ref: K2006-27X-20063-01-3)
Alternative name(s)
Swedish Research Council, VR
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Funder name
Swedish Association of Health Professionals (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ekhaga Foundation (Sweden) (Grant ref: 2006-16)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
County Council of Västerbotten (Sweden) (Grant ref: VLL 1178:3 2006)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Senior Centre of Västerbotten (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary