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

17 Apr 2019

The date of last modification

Aug 24, 2019



Application Summary


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


Trial Details


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

  1. Patients above 18 years undergoing major elective gynaecological surgeries.
  2. Those who had no prior exposure to the theatre environment

Exclusion criteria

  1. Patients not willing to give consent for the research
  2. Patients who had a past history of surgeries
  3. Patients who expose to the theatre environment (eg: Doctors and theatre staff)
  4. Emergency surgeries
  5. Known patients with mental illnesses
  6. Patients aged below 18 years


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.
  1. Compare the difference in anxiety between the intervention and control group.

  2. Compare the pre-induction vital parameter between the intervention and control group. Vital Parameters are heart rate, respiratory rate, blood pressure and random blood sugar levels.

  3. Compare the level of pain at 6 hours and 24 hours postoperatively, postoperative pain would be compared using VAS.

  4. Compare the analgesic requirement postoperatively between the two groups.

[

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

Recruiting


Funding source

Self funded


Regulatory approvals

Ministry of Health, Sri Lanka



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Colombo South Teaching Hospital

B229 Hospital Rd, Dehiwala-Mount Lavinia
0112 763 262


Secondary study sponsor (If any)

None





Trial Completion details


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