NCT02712749

Brief Summary

The Investigators verify the effectiveness of "Binaural Beats" as premedication instrument in elderly patients submitted to orthopedic surgery to reduce anxiety , post operative pain and morphine consumption

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

March 4, 2016

Last Update Submit

March 29, 2019

Conditions

AnxietyPostoperative PainMorphine Consumption

Keywords

Binaural BeatElderlypreoperative medicationpostoperative merphine consumptionpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Reduction on postoperative morphine consumption

    Difference of cumulative morphine consumption between Binaural Beat group vs Control group through patient-controlled analgesia device (PCA)

    in the first post-operative day

Secondary Outcomes (1)

  • Reduction in the level of preoperative anxiety assessed by State Anxiety inventory (STAI-1)

    at 20 minutes after a binaural beat listening session

Other Outcomes (1)

  • Postoperative pain reduction

    NRS mesurements at 8, 16 and 24 hours after surgery

Study Arms (2)

Group A : Sound with Binaural Beats

EXPERIMENTAL

Acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz through generated by the software "Gnaural" in stereo option

Device: Sound with Binaural Beats

Group B : Sound without Binaural Beats

ACTIVE COMPARATOR

Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the software "Gnaural" in mono option

Device: Sound without Binaural Beats

Interventions

Sound with Binaural BeatsDEVICE

Acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz generated by the special program Gnaural in stereo option

Group A : Sound with Binaural Beats
Sound without Binaural BeatsDEVICE

Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the program Gnaural in mono option

Group B : Sound without Binaural Beats

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjects over 65 years aged candidated to elective major orthopedic surgery
  • Stable hemodynamic and clinical conditions (ASA 1/2, Goldman Desky Class 1)
  • Absence of cognitive impairment (MMSE greater than 24)
  • Valid consent expression to the study participation
  • No history of epilepsy and other chronic neurological diseases that may interfere with the study procedures.
  • Good collaboration in activities provided by the study
  • No abnormalities at audiometric testing for the frequencies between 256 and 260 Hz.

You may not qualify if:

  • Insufficient level of cooperation or hearing loss
  • Contraindications to the use of binaural beats (a history of epilepsy)
  • Treatment with anti-anxiety drugs or major tranquillizers
  • Denial of informed consent to participate in the study
  • Presence of cognitive impairment (MMSE less than or equal to 24)
  • Presence of neurological diseases or neurological damage that interfere with the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Maria Maddalena Hospital

Volterra, Pisa, 56048, Italy

Location

Related Publications (13)

  • Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.

    PMID: 20007989BACKGROUND

  • Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res. 2000 Dec;49(6):417-22. doi: 10.1016/s0022-3999(00)00189-6.

    PMID: 11182434BACKGROUND

  • Ozalp G, Sarioglu R, Tuncel G, Aslan K, Kadiogullari N. Preoperative emotional states in patients with breast cancer and postoperative pain. Acta Anaesthesiol Scand. 2003 Jan;47(1):26-9. doi: 10.1034/j.1399-6576.2003.470105.x.

    PMID: 12492793BACKGROUND

  • Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.

    PMID: 16115248BACKGROUND

  • Kliempt P, Ruta D, Ogston S, Landeck A, Martay K. Hemispheric-synchronisation during anaesthesia: a double-blind randomised trial using audiotapes for intra-operative nociception control. Anaesthesia. 1999 Aug;54(8):769-73. doi: 10.1046/j.1365-2044.1999.00958.x.

    PMID: 10460529BACKGROUND

  • Dabu-Bondoc S, Vadivelu N, Benson J, Perret D, Kain ZN. Hemispheric synchronized sounds and perioperative analgesic requirements. Anesth Analg. 2010 Jan 1;110(1):208-10. doi: 10.1213/ANE.0b013e3181bea424. Epub 2009 Oct 27.

    PMID: 19861358BACKGROUND

  • Goodin P, Ciorciari J, Baker K, Carey AM, Harper M, Kaufman J. A high-density EEG investigation into steady state binaural beat stimulation. PLoS One. 2012;7(4):e34789. doi: 10.1371/journal.pone.0034789. Epub 2012 Apr 9.

    PMID: 22496862BACKGROUND

  • Le Scouarnec RP, Poirier RM, Owens JE, Gauthier J, Taylor AG, Foresman PA. Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. Altern Ther Health Med. 2001 Jan;7(1):58-63.

    PMID: 11191043BACKGROUND

  • Schmidt WD, O'Connor PJ, Cochrane JB, Cantwell M. Resting metabolic rate is influenced by anxiety in college men. J Appl Physiol (1985). 1996 Feb;80(2):638-42. doi: 10.1152/jappl.1996.80.2.638.

    PMID: 8929609BACKGROUND

  • Millar K, Jelicic M, Bonke B, Asbury AJ. Assessment of preoperative anxiety: comparison of measures in patients awaiting surgery for breast cancer. Br J Anaesth. 1995 Feb;74(2):180-3. doi: 10.1093/bja/74.2.180.

    PMID: 7696068BACKGROUND

  • Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.

    PMID: 12402719BACKGROUND

  • Hollenberg SM. Preoperative cardiac risk assessment. Chest. 1999 May;115(5 Suppl):51S-57S. doi: 10.1378/chest.115.suppl_2.51s.

    PMID: 10331334BACKGROUND

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersPain, Postoperative

Condition Hierarchy (Ancestors)

Mental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Alessandro Tani, MD

    Usl Area Vasta Nord Ovest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 18, 2016

Study Start

September 1, 2016

Primary Completion

March 15, 2019

Study Completion

March 28, 2019

Last Updated

April 1, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)