Home » Trials » SLCTR/2019/015
A preoperative theatre visit to reduce the anxiety: A randomized controlled trial at Colombo South Teaching Hospital
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SLCTR Registration Number
SLCTR/2019/015
Date of Registration
The date of last modification
Sep 16, 2020
Trial Status
Scientific Title of Trial
A preoperative theatre visit to reduce the anxiety: A randomized controlled trial at Colombo South Teaching Hospital
Public Title of Trial
A preoperative theatre visit to reduce the anxiety associated with surgery: A randomized controlled trial at Colombo South Teaching Hospital
Disease or Health Condition(s) Studied
Anxiety
Scientific Acronym
None
Public Acronym
None
Brief title
A preoperative theatre visit to reduce the anxiety: A randomized controlled trial at Colombo South Teaching Hospital
Universal Trial Number
U1111-1229-8172
Any other number(s) assigned to the trial and issuing authority
34/17 - Ethics Review Committee University of Sri Jayawardenepura
What is the research question being addressed?
Does a preoperative theatre visit reduce the anxiety and anxiety related adverse effects during intra and postoperative time?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Site - Colombo South Teaching Hospital, Sri Lanka.
Patients are randomly assigned to either the experimental or the control group out of each stratum in equal numbers, by attaching a pre-randomized sealed envelope to patients’ BHTs prior to the surgery. Neither the patients nor investigators will be blinded.
Intervention will be delivered by a trained research assistant (pre-intern doctor).
All patients who fall into the experimental group will be taken to the operation theatre for a simple visit 1 day prior to their allocated surgery date after 4 p.m., once surgeries in the theatre is over. They will be shown the setting of the theatre, the attire of the staff and the waiting area. Brief explanation will be given about what would happen, once they reach the waiting area and about the waiting time. All patients who fall into control group will remain in the ward. This will take around 30 minutes.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Difference in level of anxiety using, Amsterdam preoperative anxiety and information scale(APAIS) Hospital anxiety and depression scale (HADS) Visual Analogue Scale (VAS) |
[ The outcomes will be assessed one day before the surgery, at the day of surgery, after the surgery and during the hospital stay post-surgery. ] |
Secondary outcome(s)
|
1.
|
[ The outcomes will be assessed one day before the surgery, at the day of surgery, after the surgery and during the hospital stay post-surgery. ] |
Target number/sample size
24 in each group
Countries of recruitment
Sri Lanka
Anticipated start date
2019-04-25
Anticipated end date
2020-04-25
Date of first enrollment
2019-04-23
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Self funded
Regulatory approvals
Ministry of Health, Sri Lanka
Status
Approved
Date of Approval
2017-06-16
Approval number
34/17
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.Madura Jayawardana
Consultant Obstetrician and Gynecologist
Professorial Obstetrics and Gynaecology Unit, Colombo South Teaching Hospital, Kalubowila, Dehiwela, Sri Lanka
0112763069
0773140500
madurammj@yahoo.com
Contact Person for Public Queries
Dr.Madura Jayawardana
Consultant Obstetrician and Gynecologist
Professorial Obstetrics and Gynaecology Unit, Colombo South Teaching Hospital, Kalubowila, Dehiwela, Sri Lanka
0112763069
0773140500
madurammj@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
