CataractNCT07099209
Delta-Wave Hypnoanalgesia for Reducing Perioperative Anxiety in Cataract Surgery
A study testing Delta-Wave Hypnoanalgesia in people with Cataract and Anxiety, run by Military Hospital of Tunis at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Delta-Wave Hypnoanalgesia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTunisia
- Study dates
- 28 Sep 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- Undergoing cataract surgery under locoregional anesthesia
- Provided written informed consent
Who cannot join
- Hearing impairment
- Cognitive disorders
- Requirement for general anesthesia or sedation
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed 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.
- Being tested
- Delta-Wave Hypnoanalgesia
- Keywords
- Cataract Surgery, Perioperative Anxiety, Hypnosis, Audioanalgesia, Delta-Wave Stimulation
- Medical subject headings
- Cataract, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta-Wave HypnoanalgesiaBehavioural
Binaural beat audio tracks at delta frequencies (1-4 Hz) to induce deep relaxation and reduce perioperative anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Group | Experimental | Patients received delta-wave binaural beats via headphones starting 15 minutes before surgery and continuing intraoperatively. Receives: Behavioral: Delta-Wave Hypnoanalgesia |
| Control Group | No intervention | Patients received standard care with no auditory intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
The total anxiety score ranges from 4 to 20. Higher scores indicate higher levels of preoperative anxiety.
Measured: Baseline to start of surgery
Secondary outcomes (5)
Intraoperative heart rate variation
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.
Measured: Every 5 minutes throughout the surgical procedure
Intraoperative blood pressure changes
Systolic, diastolic, and mean arterial pressure (SBP, DBP, MAP) measured every 5 minutes during surgery.
Measured: Intraoperative period (every 5 minutes throughout the surgery)
Numeric Rating Scale (NRS) for pain
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.
Measured: Throughout the surgical procedure (intraoperative period)
Bispectral Index Score (BIS)
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).
Measured: Throughout the surgical procedure
Satisfaction score from patient, surgeon, and anesthesiologist (0-10 scale)
Numerical scale from 0 (minimum) to 10 (maximum). Higher scores reflect greater satisfaction.
Measured: Immediately after surgery (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start28 Sep 2023
- Primary completion12 Jan 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099209
- Sponsor's protocol ID
- Military-Hypno-CAT-2023
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to concerns related to patient privacy and confidentiality, as well as restrictions imposed by ethical approvals and informed consent agreements. Additionally, there may be legal and institutional policies limiting data sharing. We are committed to protecting participant identities and complying with all regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07099209
- Acronym / sponsor ID
- Military-Hypno-CAT-2023
- Keywords
- Cataract Surgery, Perioperative Anxiety, Hypnosis, Audioanalgesia, Delta-Wave Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Group | Experimental | Behavioral: Delta-Wave HypnoanalgesiaPatients received delta-wave binaural beats via headphones starting 15 minutes before surgery and continuing intraoperatively. |
| Control Group | No intervention | –Patients received standard care with no auditory intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75
- Undergoing cataract surgery under locoregional anesthesia
- Provided written informed consent
Key exclusion criteria (4 listed)
- Hearing impairment
- Cognitive disorders
- Requirement for general anesthesia or sedation
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delta-Wave HypnoanalgesiaBinaural beat audio tracks at delta frequencies (1-4 Hz) to induce deep relaxation and reduce perioperative anxiety. | Behavioural | Hypnosis Group |
Primary outcome
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.
5 secondary outcomes
Intraoperative heart rate variation
Time frame: Every 5 minutes throughout the surgical procedure
Intraoperative blood pressure changes
Time frame: Intraoperative period (every 5 minutes throughout the surgery)
Numeric Rating Scale (NRS) for pain
Time frame: Throughout the surgical procedure (intraoperative period)
Bispectral Index Score (BIS)
Time frame: Throughout the surgical procedure
Satisfaction score from patient, surgeon, and anesthesiologist (0-10 scale)
Time frame: Immediately after surgery (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to concerns related to patient privacy and confidentiality, as well as restrictions imposed by ethical approvals and informed consent agreements. Additionally, there may be legal and institutional policies limiting data sharing. We are committed to protecting participant identities and complying with all regulatory requirements.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delta-Wave Hypnoanalgesia in people with Cataract and Anxiety, run by Military Hospital of Tunis at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (time frame: Baseline to start of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.