Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202012719779261 Date of Registration: 14/12/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF VIDEO-BASED INFORMATION ON PRE-OPERATIVE STATE TRAIT ANXIETY INVENTORY SCORES IN ADULT PATIENTS PRESENTING FOR ELECTIVE CAESAREAN SECTION
Official scientific title EFFECT OF VIDEO-BASED INFORMATION ON PRE-OPERATIVE STATE TRAIT ANXIETY INVENTORY SCORES IN ADULT PATIENTS PRESENTING FOR ELECTIVE CAESAREAN SECTION
Brief summary describing the background and objectives of the trial Background: Preoperative anxiety is a common occurrence in patients presenting for surgery with a reported incidence of up to 80%. Higher incidences have been reported in the female population and in the obstetric population compared to general surgical patients. Increased preoperative anxiety has been associated with increased anaesthetic requirements, a more turbulent immediate postoperative course, poor patient satisfaction, protracted hospital stays, and poorer surgical outcomes. Provision of information relating to surgery and anaesthesia to patients has been proven to have benefit in allaying anxiety. However, the best format of information dissemination remains unknown and especially so targeting a specific patient population. Objective: The primary objective was to determine the effect of video information in addition to the pre-anaesthetic review on the mean preoperative STAI-S score in adult patients presenting for elective caesarean section under spinal anaesthesia at AKUHN. Secondary objectives were to determine the prevalence of preoperative anxiety in the obstetric population presenting for elective caesarean section at AKUHN as well as to determine the effect of age, level of education, parity and exposure to previous anaesthetic on preoperative anxiety.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Caesarean section under spinal anaesthesia ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Stat Trait Anxiety Inventory
Purpose of the trial Psychosocial
Anticipated trial start date 01/11/2018
Actual trial start date 01/11/2018
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants) 38
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2018 REC 68 v3 Research Ethics Committee AKU Kenya
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Information video on spinal anaesthesia for elective caesarean section Shown a video for a spinal block during the pre-anesthesia assessment session 7.55 minutes Shown a video for a spinal block 21
Control Group Normal practice arm Explanation done without the use of video information None No video information 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age 18 years and above • Elective cesarean section • Reviewed in clinic • Has consented to a spinal anesthetic • Consent given for study participation • Previous neuraxial anesthetic • Patients unable fill the questionnaire including those unable to read and/or write non-English speaking, or with markedly poor eyesight • Patients with factors that predispose to high anxiety levels including high-risk pregnancies, concurrent uncontrolled thyroid disorder, and history of psychiatric illness • Use of psychotropic medications that may give erroneous anxiety scores • Patients premedicated with an anxiolytic prior to filling the questionnaire Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
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 24/10/2018 Research Ethics Committee AKU Kenya
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 • To determine the effect of video information on the mean preoperative State Anxiety scores in adult patients presenting for elective caesarean section under spinal anesthesia at AKUHN Prior to cesarean section
Secondary Outcome • To determine the prevalence of preoperative anxiety in the obstetric population presenting for elective cesarean section at AKUHN • To determine the effect of age, level of education, parity, and exposure to the previous anaesthetic on change in mean preoperative anxiety scores. Before cesarean section
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 Committee 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 Hospital Nairobi 3rd Parklands Avenue off Limuru Road Nairobi 00100 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
1. Operating theatres anaesthesia consultants Aga Khan University Hospital Nairobi 2. Dr Jasmit Shah Statistician Aga Khan University Nairobi 3. Mr Dominic Mutai and Sabbath Kivuva Video technician 4. 3rd Paklands Avenue off Limuru Road Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Timothy Kanyeki tkanyeki@gmail.com +254721944 3rd Parklands Avenue off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Anaesthesiologist
Role Name Email Phone Street address
Scientific Enquiries Vitalis Mungayi vitalis.mung'ayi@aku.edu +254904010 3rd Parklands Avenue off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Consultant and Faculty
Role Name Email Phone Street address
Public Enquiries Research Committee Research Committee research.support@aku.edu +254711092148 3rd Parklands Avenue off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research Committee
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 37 patients were randomized in this study. The mean STAI-T score in the sampled population was 45.64 (SD 5.625). The mean baseline STAI-S score was 46.32 (SD 4.911). There was no statistically significant difference in change in STAI score between the video and control arms (p>0.005). There was no significant association between STAI scores and the age, level of education, parity, or previous anesthetic history of the participants. Study Protocol 12 months None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/11/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/11/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks None
Changes to trial information