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
This RCT aims to study the effect of preoperative counselling in reducing patients fear and visual perception during vitrectomy under local anaesthesia.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care