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Delta-Wave Hypnoanalgesia for Reducing Perioperative Anxiety in Cataract Surgery

NCT07099209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-08-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

Delta-Wave Hypnoanalgesia

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

Sponsors & Collaborators

  • Military Hospital of Tunis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2024-01-12
Completion
2024-05-15

Countries

  • Tunisia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099209 on ClinicalTrials.gov