Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
na
Study information
Scientific title
The benefits of an interactive, individualized online patient pathway for patients undergoing minimally invasive radioguided parathyroidectomy (MIRP). A prospective, double-blinded, randomized clinical trial
Acronym
Study hypothesis
The provision of an online, interactive patient pathway would offer an appropriate means of delivering patient information that would be viewed positively by patients.
Ethics approval
Ethics Committee of University College Cork (Ireland) approved on the 19th Feb 2007 (ref: ECM 4 (q) 06/03/07)
Study design
Prospective double blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patient education prior to surgery
Intervention
Web based access to information about their hospital process prior to undergoing MIRP.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Anxiety levels 24 hours pre-operatively:
Anxiety was measured the evening before surgery using the anxiety portion of the externally validated Hospital Anxiety and Depression Scale (HADS).
Secondary outcome measures
1. Postoperative pain was scored using a visual analogue pain score and analgesia requirements were assessed according to the World Health Organization (WHO) analgesia ladder 24 hours following surgery.
2. Postoperative assessments of satisfaction with capacity to consent and perception of website utility were measured.
Overall trial start date
19/02/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients undergoing elective MIRP
2. Age over 18
3. Full capacity to consent to both the study and the operation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64
Participant exclusion criteria
1. Cognitive or visual impairment
2. Lack of access to internet facilities
Recruitment start date
19/02/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Ireland
Trial participating centre
Department of Surgery
Cork
-
Ireland
Funders
Funder type
Hospital/treatment centre
Funder name
Cork University Hospital / University College Cork (Ireland) - Investigator led and funded
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