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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01383629
Enrollment
100
Registered
2011-06-28
Start date
2010-01-31
Completion date
2011-03-31
Last updated
2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any Patients Undergoing Vitrectomy Under Local Anaesthesia

Keywords

Vitrectomy, Local anaesthesia, Counselling, Fear, Visual perception

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.

Interventions

BEHAVIORALCounselling

Preoperative counselling

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient fear1 weekPatient fear during surgery is measured on a visual analogue scale

Secondary

MeasureTime frameDescription
Type of visual perception during vitrectomy surgery under local anaesthesia1 weekPatients visual perception during surgery

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026