Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201601001423246 Date of Approval: 15/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of a preanaesthesia clinic consultation on adult patient anxiety at a tertiary hospital in Kenya; A cohort study
Official scientific title The effect of a preanaesthesia clinic consultation on adult patient anxiety at a tertiary hospital in Kenya; A cohort study
Brief summary describing the background and objectives of the trial Background Preoperative anxiety is a common perioperative complication seen in approximately 11-80% of adults undergoing surgery. One of the goals of the preanaesthesia clinic is to allay anxiety. A preanaesthesia clinic evaluation has been shown to reduce anxiety however current studies done on anxiety and the preanaesthesia clinic have not quantified this reduction. Objective To determine the reduction in anxiety in patients evaluated in the clinic versus those evaluated in the ward.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2015
Actual trial start date 12/01/2015
Anticipated date of last follow up 29/01/2016
Actual Last follow-up date 29/01/2016
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 51
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2013/REC-56(v3) Health Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ward group Ward preanaesthesia assessment Prior to surgery Ward preanaesthesia assessment 23 Active-Treatment of Control Group
Experimental Group Preanaesthesia clinic assessment 48 hours prior to surgery Prior to surgery Preanaesthesia clinic assessment 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All surgical patients attending the pre-anaesthesia clinic at least 48 hours prior to elective surgery and all patients having a preanaesthesia evaluation in the wards a day prior to elective surgery aged above 18 years were included in the study. 1. Patients seen in the anaesthesia clinic more than 2 weeks before elective surgery. 2. Patients seen in the ward more than 24 hours prior to elective surgery. 3. Patients undergoing surgical procedures due to malignancy. 4. Patients undergoing cardiac surgery. 5. Patients with diagnosed psychiatric illness. 6. Patients undergoing neurosurgery for ailments that may cause changes in cognitive function. 7. Patients, who cannot understand, read or write high school level English. 8. Inability to understand the consent due to language barrier, inability to read or write. 9. Refusal to participate in the study. 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/03/2014 Aga khan University East Africa
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue off Limuru Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The aim of the study was to assess whether the standard preanaesthesia evaluation in the outpatient clinic would reduce the preoperative anxiety by 10 points as assessed by the STAI score when compared to a standard preoperative evaluation in the ward. Preoperative area in theatre
Primary Outcome 3. To determine the influence of prior anaesthetic experience on reduction in anxiety on preanaesthetic patients Preoperative area in theatre
Secondary Outcome 1. To determine the influence of gender on reduction in anxiety in pre-anaesthetic patients Preoperative area in theatre
Secondary Outcome 2. To determine the influence of duration of hospital stay on reduction in anxiety in preanaesthetic patients. Preoperative area in theatre
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital Nairobi 3rd Parklands Avenue off Limuru road Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
University research council 3rd Parklands Avenue off Limuru road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University East Africa 3rd Parklands Avenue off Limuru road Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Aga Khan University Hospital Nairobi 3rd Parklands Avenue off Limuru road Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vitalis Mungayi vitalis.mung'ayi@aku.edu +254 203662158 3rd parklands Avenue off Limuru road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Fulltime Faculty
Role Name Email Phone Street address
Principal Investigator Anthony Kamau anthony.kamau@aku.edu +254 203662158 3rd parklands Avenue off Limuru road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya
Role Name Email Phone Street address
Principal Investigator Gerald Yonga gerald.yonga@aku.edu +254 203662158 3rd parklands Avenue off Limuru road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Fulltime Faculty
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information