The Effect of Intraoperative Music Listening on Sevoflurane Consumption and Recovery Parameters

NCT02220452 | Unknown DMC

• 1 other identifier: Sofia-Music
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• The perioperative period can be a significant source of psychological burden, anxiety and fear for patients
• Both pharmacological and non-pharmacological methods have been proposed in order to alleviate perioperative stress
• Music is one of the non-pharmacological methods which have been used in this context, with favorable effects both preoperatively and postoperatively
• The attenuation of perioperative stress through music listening is probably due to the activation of emotional and cognitive processes that evoke feeling of pleasure and can distract patients' attention from fear and unpleasant thoughts related to the surgical procedure
• Little information is available regarding the effect of intraoperative music listening on anesthetized, unconscious patients
• There is a notion that general anesthesia does not completely abolish auditory perception and that some processing of intraoperative events can occur in unconscious patients, even in the absence of postoperative recall
• The investigators hypothesis is that intraoperative music listening can decrease anesthetic requirements and reduce sevoflurane consumption in female patients subjected to abdominal hysterectomy for benign disease.

Conditions

Anesthesia; Stress; Music; Auditory Perception

Outcome Measures

Primary Outcomes (1)

• sevoflurane consumption during general anesthesia

  the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined

  change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours

Secondary Outcomes (6)

• recall of postoperative events

  participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour

• recall of postoperative sounds

  participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour

• occurence of postoperative nausea or vomiting

  participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour

• intensity of postoperative pain

  participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour

• satisfaction from anesthesia

  participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour

Other Outcomes (2)

• sleep diary

  first postoperative night

• sleep diary

  second postoperative night

Study Arms (2)

music listening during anesthesia

EXPERIMENTAL

In patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia

Other: music listening during anesthesia

absence of music listening during anesthesia

ACTIVE COMPARATOR

In patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music

Other: absence of music listening during anesthesia

Interventions

music listening during anesthesia OTHER

In patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia

music listening during anesthesia

absence of music listening during anesthesia OTHER

In patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music

absence of music listening during anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective hysterectomy for benign disease

You may not qualify if:

• hearing impairment
• psychiatric disease (depression, dementia)
• mental disability
• concurrent treatment with medication known to affect anesthetic requirement, such as benzodiazepines, anticonvulsants, opioids, psychotropic drugs or alcohol

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Aretaieion University Hospital

Athens, 115 28, Greece

RECRUITING

Related Publications (7)

• Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14.

  PMID: 19388893 BACKGROUND

• Wang SM, Kulkarni L, Dolev J, Kain ZN. Music and preoperative anxiety: a randomized, controlled study. Anesth Analg. 2002 Jun;94(6):1489-94, table of contents. doi: 10.1097/00000539-200206000-00021.

  PMID: 12032013 BACKGROUND

• Ganidagli S, Cengiz M, Yanik M, Becerik C, Unal B. The effect of music on preoperative sedation and the bispectral index. Anesth Analg. 2005 Jul;101(1):103-6, table of contents. doi: 10.1213/01.ANE.0000150606.78987.3B.

  PMID: 15976214 BACKGROUND

• Zhang XW, Fan Y, Manyande A, Tian YK, Yin P. Effects of music on target-controlled infusion of propofol requirements during combined spinal-epidural anaesthesia. Anaesthesia. 2005 Oct;60(10):990-4. doi: 10.1111/j.1365-2044.2005.04299.x.

  PMID: 16179044 BACKGROUND

• Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Human learning during general anaesthesia and surgery. Br J Anaesth. 1991 Feb;66(2):170-8. doi: 10.1093/bja/66.2.170.

  PMID: 1817616 BACKGROUND

• Evans C, Richardson PH. Improved recovery and reduced postoperative stay after therapeutic suggestions during general anaesthesia. Lancet. 1988 Aug 27;2(8609):491-3. doi: 10.1016/s0140-6736(88)90131-6.

  PMID: 2900410 BACKGROUND

• Lindh A, Carlstrom K, Eklund J, Wilking N. Serum steroids and prolactin during and after major surgical trauma. Acta Anaesthesiol Scand. 1992 Feb;36(2):119-24. doi: 10.1111/j.1399-6576.1992.tb03436.x.

  PMID: 1532279 BACKGROUND

Study Officials

• Kassiani Theodoraki, PhD, DEAA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD, DEAA

CONTACT

#306974634162; ktheodoraki@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anaesthesiology

Study Record Dates

• First Submitted: August 17, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

GR (1)