Delta-Wave Hypnoanalgesia for Reducing Perioperative Anxiety in Cataract Surgery

NCT ID: NCT07099209

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2024-05-15

Brief Summary

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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.

Detailed Description

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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

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Cataract Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Hypnosis Group

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

Group Type EXPERIMENTAL

Delta-Wave Hypnoanalgesia

Intervention Type BEHAVIORAL

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

Control Group

Patients received standard care with no auditory intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Delta-Wave Hypnoanalgesia

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Hospital of Tunis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Main Military Hospital of Tunis

Tunis, Montfleury, Tunisia

Site Status

Countries

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Tunisia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Military-Hypno-CAT-2023

Identifier Type: -

Identifier Source: org_study_id

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