The Effect of Preoperative Counseling on Patient Fear From Visual Experience During Vitrectomy Surgery Under Regional Anesthesia

Not Applicable

Completed

• Conditions: Any Patients Undergoing Vitrectomy Under Local Anaesthesia
• Interventions: Behavioral: Counselling

• Registration Number: NCT01383629
• Lead Sponsor: University of Malaya

Brief Summary

This RCT aims to study the effect of preoperative counselling in reducing patients fear and visual perception during vitrectomy under local anaesthesia.

Detailed Description

This was a single-blinded, randomised clinical trial conducted at University of Malaya Medical Centre, Kuala Lumpur, Malaysia, and approved by the Institutional Review Board of the hospital. Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were included. Patients who could not understand English, who had psychiatric illness or mental retardation, or who refused to give consent were excluded.

After obtaining informed consent, patients were randomised to two groups: Group A received additional preoperative counseling while Group B did not receive any additional counseling. Both groups received routine preoperative counseling regarding potential risks and benefits of vitrectomy by an ophthalmologist one day prior to the operation.

The information covered during counselling and the method of delivery were standardised for all patients. An ophthalmologist reviewed the patient one day prior to the operation and patients who were randomised to additional counselling were counselled regarding the possible visual perceptions that they might encounter during surgery. These included lights, colours, movements, flashes, instruments and surgeon's hands or face. Twenty four hours after the surgery, another ophthalmologist blinded to the patient randomisation interviewed the patients on their visual perceptions during surgery using a standard questionnaire. Patients were interviewed regarding the types of visual sensations they perceived and if they caused fear to them. Patients were asked to grade their fear based on a visual analogue scale. The fear was graded from 0 to 10, with a score of 0 meaning no fear and a score of 10 being the maximum or extreme fear. At the end of the questionnaire the interviewer was allowed to ask the patient if he or she has received preoperative counselling and if they prefer to be or not to be counselled. Patients were asked to describe in details the images and objects that they saw during the operation. The data were analyzed using SPSS version 17.0.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Last Update Submitted: 2011-06-27
• Study First Posted: 2011-06-28
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were included

Exclusion Criteria

• Patients who could not understand English, who had psychiatric illness or mental retardation, or who refused to give consent were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative counselling	Counselling	Counselling to patient about what to expect during vitrectomy surgery under local anaesthesia

Primary Outcome Measures

Name	Time	Method
Patient fear	1 week	Patient fear during surgery is measured on a visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Type of visual perception during vitrectomy surgery under local anaesthesia	1 week	Patients visual perception during surgery

Trial Locations

Locations (1)

Universiy of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia