Abdominal massage for people with constipation: experiences, effects and cost effectiveness

ISRCTN	ISRCTN64345887
DOI	https://doi.org/10.1186/ISRCTN64345887
Protocol serial number	N/A
Sponsor	Swedish Research Council (Sweden)
Funders	Swedish Research Council (Sweden) (Grant ref: K2006-27X-20063-01-3), Swedish Association of Health Professionals (Sweden), Ekhaga Foundation (Sweden) (Grant ref: 2006-16), County Council of Västerbotten (Sweden) (Grant ref: VLL 1178:3 2006), Senior Centre of Västerbotten (Sweden)

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

Department of Nursing
Umeå University
Umeå
SE-901 87
Sweden

Phone	+46 9 07 86 9162
Email	catrine.jacobsson@nurs.umu.se

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	26/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan