Condition category
Digestive System
Date applied
15/08/2008
Date assigned
21/11/2008
Last edited
21/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vr.se/2.69f66a93108e85f68d480000.html

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

Publication citations

Additional files

Editorial Notes