NCT07099209

Delta-Wave Hypnoanalgesia for Reducing Perioperative Anxiety in Cataract Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Military Hospital of Tunis · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Delta-Wave Hypnoanalgesia	Binaural beat audio tracks at delta frequencies (1-4 Hz) to induce deep relaxation and reduce perioperative anxiety.

Timeline

• Start date: 2023-09-28
• Primary completion: 2024-01-12
• Completion: 2024-05-15
• First posted: 2025-08-01
• Last updated: 2025-08-03

Locations

1 site across 1 country: Tunisia