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

Any Patients Undergoing Vitrectomy Under Local Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383629
• Other study ID #: UMERC004
• Status: Completed
• Phase: N/A
• First received: June 27, 2011
• Last updated: June 27, 2011
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Any Patients Undergoing Vitrectomy Under Local Anaesthesia

Intervention

Behavioral:
• Counselling
Preoperative counselling

Locations

Country	Name	City	State
Malaysia	Universiy of Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Tan CS, Mahmood U, O'Brien PD, Beatty S, Kwok AK, Lee VY, Au Eong KG. Visual experiences during vitreous surgery under regional anesthesia: a multicenter study. Am J Ophthalmol. 2005 Dec;140(6):971-975. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient fear	Patient fear during surgery is measured on a visual analogue scale	1 week	No
Secondary	Type of visual perception during vitrectomy surgery under local anaesthesia	Patients visual perception during surgery	1 week	No