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NCT Number: NCT07099209

Delta-Wave Hypnoanalgesia for Reducing Perioperative Anxiety in Cataract Surgery

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.

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Key information

Conditions

Cataract Anxiety Anxiety Disorders Eye Diseases Lens Diseases Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Main Military Hospital of Tunis

Tunis, Montfleury, 1008, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delta-Wave Hypnoanalgesia

Behavioral

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

Primary outcomes

  1. Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: Baseline to start of surgery

    The total anxiety score ranges from 4 to 20. Higher scores indicate higher levels of preoperative anxiety.

Secondary outcomes

  1. Intraoperative heart rate variation

    Time frame: Every 5 minutes throughout the surgical procedure

    Heart rate will be recorded at 5-minute intervals during the surgery. Variations in heart rate will be analyzed as an indicator of autonomic response to anxiety and hypnoanalgesia. Lower or more stable values may reflect a calming effect.

  2. Intraoperative blood pressure changes

    Time frame: Intraoperative period (every 5 minutes throughout the surgery)

    Systolic, diastolic, and mean arterial pressure (SBP, DBP, MAP) measured every 5 minutes during surgery.

  3. Numeric Rating Scale (NRS) for pain

    Time frame: Throughout the surgical procedure (intraoperative period)

    Ranging from 0 to 10. A score of 0 indicates "no pain," while a score of 10 indicates "the worst pain imaginable." Higher scores indicate worse pain perception.

  4. Bispectral Index Score (BIS)

    Time frame: Throughout the surgical procedure

    ranging from 0 to 100. Values below 60 indicate deep sedation, while values between 61 and 90 indicate moderate sedation to mild anxiolysis. Higher scores indicate higher levels of consciousness (less sedation).

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

    Time frame: Immediately after surgery (Day 0)

    Numerical scale from 0 (minimum) to 10 (maximum). Higher scores reflect greater satisfaction.

Sponsors and collaborators

Lead sponsor

Military Hospital of Tunis

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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