Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NAPREC 97.053
Study information
Scientific title
Acronym
Study hypothesis
Does massage for chronic non-malignant pain reduce pain and anxiety?
Ethics approval
Oxford Nursing and Allied Professions Ethics Committee (NAPREC) (ref: 97.053)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Chronic non-malignant pain
Intervention
Intervention: 15 min massage
Control intervention: 15 min talk with a nurse about their pain
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Pain, assessed immediately after massage and 1, 2, 3 and 4 hours later using a Visual Analogue Scale (VAS) and the McGill Pain Questionnaire
2. Anxiety, assessed immediately after massage and 1, 2, 3 and 4 hours later by the short form Spielberg State-Trait Anxiety scale
Secondary outcome measures
Overall rating of intervention by patient and observer (researcher), assessed by an interview after intervention (normally at 4 hours, however for some of the participants who dropped out of study the interview took place at a earlier timepoint)
Overall trial start date
01/01/1998
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients aged 18 or over attending pain relief unit whose pain was described as moderate or severe.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Non-English speakers
2. Taken analgesics within two hours prior to treatment
Recruitment start date
01/01/1998
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Whichford House
Oxford
OX4 2JY
United Kingdom
Sponsor information
Organisation
Royal College of Nursing Institute (UK)
Sponsor details
Whichford House
Building 1400
Parkway Court
Oxford Business Park
Oxford
OX4 2JY
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Oxfordshire Health Services Research Fund (UK)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18601729
Publication citations
-
Results
Seers K, Crichton N, Martin J, Coulson K, Carroll D, A randomised controlled trial to assess the effectiveness of a single session of nurse administered massage for short term relief of chronic non-malignant pain., BMC Nurs, 2008, 7, 10, doi: 10.1186/1472-6955-7-10.