The Use of Delta-Wave Hypnosis as a Non-Pharmacological Adjunct to Reduce Perioperative Anxiety During Cataract Surgery: A Prospective, Randomized, Single-Blind Study
Phase: NA
Conditions: Cataract, Anxiety
Sponsor: Military Hospital of Tunis

                                                                                                                         15-09-2023 
 
The Use of Delta-Wave Hypnoanalgesia as a Non-Pharmacological Adjunct to Reduce 
Perioperative Anxiety During Cataract Surgery: A Prospective Randomized Single-Blind 
Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Study Design and Population: 
A prospective, randomized, single-blind study, conducted over twelve weeks. The study was 
approved by the hospital institutional ethical committee “The Local Committee For The 
Protection Of Persons” under the number (09/2023/CLPP). Informed consent was obtained 
from all the recruited individuals. Patients aged 18-75 years scheduled for cataract surgery 
under regional anesthesia were included. Exclusion criteria included auditory or cognitive 
impairments, need for general anesthesia, or sedation. 
 
Intervention: 
198 Patients were randomized into two group. A total of 99 subjects were allocated to each 
group. The hypnoanalgesia group (H) received delta-wave binaural beats via headphones, 
while the control group (T) received no auditory intervention. Both groups underwent 
standard locoregional anesthesia (LRA). 
 
Outcome Measures: 
Primary outcomes included changes in mean heart rate (HR), systolic blood pressure (SBP), 
diastolic blood pressure (DBP), and mean arterial pressure (MAP). Hemodynamic and 
respiratory parameters were recorded at fixed intervals of five minutes. Secondary outcomes 
included, The Amsterdam Preoperative Anxiety and Information Scale (APAIS) scores for 
anxiety (Table 1). 
 
Numeric Rating Scale (NRS) to assess pain severity using a 0 to 10 scale, with zero meaning 
“no pain” and 10 meaning “the worst pain imaginable”. 
Bispectral index (BIS) was employed to evaluate level of conscious sedation through an 
electroencephalogram sensor on a scale of 1-100:  A value below 60 are indicative of deep 
sedation, whereas values between 61 and 90 correlate with moderate sedation to mild 
anxiolysis. 
A satisfaction assessment score has been adopted to measure the level of postoperative 
satisfaction of the patient, the anesthesiologist, and the surgeon. This tool is based on a 
numerical scale from 0 to 10, where 1 indicates complete dissatisfaction, 5 moderate 
satisfaction, and 10 maximum satisfaction.