Delta-Wave Hypnoanalgesia for Reducing Perioperative Anxiety in Cataract Surgery

NCT07099209 | Completed

• 1 other identifier: Military-Hypno-CAT-2023
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Anxiety

Keywords

Cataract Surgery; Perioperative Anxiety; Hypnosis; Audioanalgesia; Delta-Wave Stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Intraoperative heart rate variation

  Every 5 minutes throughout the surgical procedure

• Intraoperative blood pressure changes

  Intraoperative period (every 5 minutes throughout the surgery)

• Numeric Rating Scale (NRS) for pain

  Throughout the surgical procedure (intraoperative period)

• Bispectral Index Score (BIS)

  Throughout the surgical procedure

• Satisfaction score from patient, surgeon, and anesthesiologist (0-10 scale)

  Immediately after surgery (Day 0)

Study Arms (2)

Hypnosis Group

EXPERIMENTAL

Patients received delta-wave binaural beats via headphones starting 15 minutes before surgery and continuing intraoperatively.

Behavioral: Delta-Wave Hypnoanalgesia

Control Group

NO INTERVENTION

Patients received standard care with no auditory intervention.

Interventions

Delta-Wave Hypnoanalgesia BEHAVIORAL

Binaural beat audio tracks at delta frequencies (1-4 Hz) to induce deep relaxation and reduce perioperative anxiety.

Hypnosis Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Undergoing cataract surgery under locoregional anesthesia
• Provided written informed consent

You may not qualify if:

• Hearing impairment
• Cognitive disorders
• Requirement for general anesthesia or sedation
• Refusal to participate

Sponsors & Collaborators

• Military Hospital of Tunis: lead

Study Sites (1)

Main Military Hospital of Tunis

Tunis, Montfleury, 1008, Tunisia

Location

MeSH Terms

Conditions

Cataract; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 1, 2025
• Study Start: September 28, 2023
• Primary Completion: January 12, 2024
• Study Completion: May 15, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)