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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis Group | Experimental | Patients received delta-wave binaural beats via headphones starting 15 minutes before surgery and continuing intraoperatively. |
|
| Control Group | No Intervention | Patients received standard care with no auditory intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta-Wave Hypnoanalgesia | Behavioral | Binaural beat audio tracks at delta frequencies (1-4 Hz) to induce deep relaxation and reduce perioperative anxiety. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amsterdam Preoperative Anxiety and Information Scale (APAIS) | The total anxiety score ranges from 4 to 20. Higher scores indicate higher levels of preoperative anxiety. | Baseline to start of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative heart rate variation | 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. | Every 5 minutes throughout the surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Military Hospital of Tunis | Tunis | Montfleury | 1008 | Tunisia |
Individual participant data will not be shared due to concerns related to patient privacy and confidentiality, as well as restrictions imposed by ethical approvals and informed consent agreements. Additionally, there may be legal and institutional policies limiting data sharing. We are committed to protecting participant identities and complying with all regulatory requirements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2023 | Jul 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2023 | Jul 14, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2023 | Jul 14, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D001523 | Mental Disorders |
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| Intraoperative blood pressure changes |
Systolic, diastolic, and mean arterial pressure (SBP, DBP, MAP) measured every 5 minutes during surgery. |
| Intraoperative period (every 5 minutes throughout the surgery) |
| Numeric Rating Scale (NRS) for pain | 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. | Throughout the surgical procedure (intraoperative period) |
| Bispectral Index Score (BIS) | 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). | Throughout the surgical procedure |
| Satisfaction score from patient, surgeon, and anesthesiologist (0-10 scale) | Numerical scale from 0 (minimum) to 10 (maximum). Higher scores reflect greater satisfaction. | Immediately after surgery (Day 0) |