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Delta-Wave Hypnoanalgesia for Reducing Perioperative Anxiety in Cataract Surgery

M

Military Hospital of Tunis

Status

Completed

Conditions

Cataract
Anxiety

Treatments

Behavioral: Delta-Wave Hypnoanalgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT07099209
Military-Hypno-CAT-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

198 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

198 participants in 2 patient groups

Hypnosis Group
Experimental group
Description:
Patients received delta-wave binaural beats via headphones starting 15 minutes before surgery and continuing intraoperatively.
Treatment:
Behavioral: Delta-Wave Hypnoanalgesia
Control Group
No Intervention group
Description:
Patients received standard care with no auditory intervention.

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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