Anxiety, Cataract
Conditions
Keywords
Cataract Surgery, Perioperative Anxiety, Hypnosis, Audioanalgesia, Delta-Wave Stimulation
Brief summary
This prospective, randomized, single-blind trial evaluated the effect of delta-wave binaural beat audio hypnoanalgesia, a non-pharmacological hypnosis technique, on reducing perioperative anxiety and improving hemodynamic stability during cataract surgery performed under local anesthesia. A total of 198 patients were randomized into two groups: one group received delta-wave auditory stimulation, while the control group received standard care without auditory intervention. The primary outcomes measured included changes in anxiety levels, assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), as well as heart rate and blood pressure parameters.
Detailed description
This prospective interventional study aimed to assess the efficacy of delta-wave auditory hypnoanalgesia, a non-pharmacological adjunct technique, during cataract surgery performed under regional anesthesia. Patients in the hypnosis group received binaural beats with delta-frequency waves through headphones before and during the operation. The control group received no auditory stimulation. Hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded, alongside assessments of anxiety using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), pain measured by the Numeric Rating Scale (NRS), bispectral index (BIS) monitoring, and patient satisfaction scores at various time points. The findings support the anxiolytic effect of delta-wave hypnoanalgesia and suggest its potential role in improving patient comfort and satisfaction during cataract surgery.
Interventions
BEHAVIORALDelta-Wave Hypnoanalgesia
Binaural beat audio tracks at delta frequencies (1-4 Hz) to induce deep relaxation and reduce perioperative anxiety.
Sponsors
Military Hospital of Tunis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 * Undergoing cataract surgery under locoregional anesthesia * Provided written informed consent
Exclusion criteria
* Hearing impairment * Cognitive disorders * Requirement for general anesthesia or sedation * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amsterdam Preoperative Anxiety and Information Scale (APAIS) | Baseline to start of surgery | The total anxiety score ranges from 4 to 20. Higher scores indicate higher levels of preoperative anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative heart rate variation | Every 5 minutes throughout the surgical procedure | Heart rate will be recorded at 5-minute intervals during the surgery. Variations in heart rate will be analyzed as an indicator of autonomic response to anxiety and hypnoanalgesia. Lower or more stable values may reflect a calming effect. |
| Intraoperative blood pressure changes | Intraoperative period (every 5 minutes throughout the surgery) | Systolic, diastolic, and mean arterial pressure (SBP, DBP, MAP) measured every 5 minutes during surgery. |
| Numeric Rating Scale (NRS) for pain | Throughout the surgical procedure (intraoperative period) | Ranging from 0 to 10. A score of 0 indicates no pain, while a score of 10 indicates the worst pain imaginable. Higher scores indicate worse pain perception. |
| Bispectral Index Score (BIS) | Throughout the surgical procedure | ranging from 0 to 100. Values below 60 indicate deep sedation, while values between 61 and 90 indicate moderate sedation to mild anxiolysis. Higher scores indicate higher levels of consciousness (less sedation). |
| Satisfaction score from patient, surgeon, and anesthesiologist (0-10 scale) | Immediately after surgery (Day 0) | Numerical scale from 0 (minimum) to 10 (maximum). Higher scores reflect greater satisfaction. |
Countries
Tunisia
Outcome results
None listed