AzTrials
AzTrials

AnxietyNCT04813978

The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

A study testing Music in people with Anxiety and Music, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anxiety is a common phenomenon among patients who are undergoing surgery. It is a condition characterized by stress, nervousness, fear, unpleasant feeling, and higher activity of Autonomic Nervous System. The current studies demonstrated that listening to music, reduces anxiety levels. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Music, Preoperative
What is being tested?
Music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteNepal
Study dates
8 Apr 2021to 1 Jul 2021
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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age more than 18 years scheduled for elective surgery
  • American Society of Anaesthesiologists Physical Status I, II

Who cannot join

  • Patient's refusal
  • Patient's with known auditory disability
  • Psychiatric disorder
  • Altered mental status
  • Patients routinely taking CNS depressant drugs (eg : Diazepam, Clonazepam)

Trial locations and contacts

1 site in 1 country.

Nepal1 site

  • Maharajgunj medical campus, TUTH

    Kathmandu

Other trials in Nepal

About this study

Anxiety is a common phenomenon among patients who are undergoing surgery. It is a condition characterized by stress, nervousness, fear, unpleasant feeling, and higher activity of Autonomic Nervous System. The current studies demonstrated that listening to music, reduces anxiety levels.

Read the detailed description

Pre-operative anxiety is recognised as a potential and preventable risk factor for post-operative complications. It is estimated that between 25% to 80% of patients admitted to hospital for surgery experience pre-operative anxiety, and anxiety can negatively influence patient recovery.Physiologically pre-operative anxiety can lead to autonomic dysfunction and can modify inflammatory responses, platelet activity, and immunologic functioning. The Beck Anxiety Inventory(BAI), created by Aaron T. Beck is a 21 questions multiple choice self report inventory which measures the severity of an anxiety in adults and adolescents. It has been widely used in clinical research in mental health care mainly to measure general anxiety. The total score for all 21 symptoms can range between 0 and 63 points. A total score of 0 - 7 is interpreted as "Minimal" level of anxiety, 8 - 15 as "Mild"; 16 - 25 as "Moderate" and 26 - 63 as "Severe" level of anxiety.

This study aims to compare the alleviation of Pre-operative anxiety in patients undergoing surgery with or without music.

Being tested
Music
Keywords
anxiety, music, preoperative
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MusicOther

    For the interventional group, in addition to normal nursing care, patients will listen to instrumental relaxing music genre consist of pitch, rhythm and tone color for 30 minutes pre-operatively, using mp3 player and over-ear headphones to reduce outside interference, at a volume of the patient's preference.

Study groups in NCT04813978
Study groupRoleWhat they receive
Group B (control)No interventionHead phone will be placed and music will not be played, will get normal nursing care
Group A (music intervention)ExperimentalFor the interventional group, in addition to normal nursing care, patients will listen to instrumental relaxing music genre consist of pitch, rhythm and tone color for 30 minutes pre-operatively, using mp3 player and over-ear headphones to reduce outside interference, at a volume of the patient's preference.
Receives: Other: Music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of music therapy on preoperative anxiety in elective surgery

    preoperative anxiety will be assessed by using Beck's Anxiety Inventory in one group and the other group will only get routine nursing care.The total score for all 21 symptoms can range between 0 and 63 points. A total score of 0 - 7 is interpreted as "Minimal" level of anxiety, 8 - 15 as "Mild"; 16 - 25 as "Moderate" and 26 - 63 as "Severe" level of anxiety. More the score greater the anxiety.

    Measured: 6 months

Secondary outcomes (4)

  1. The effect of music therapy on preoperative anxiety in elective surgery

    systolic blood pressure

    Measured: 6 months

  2. The effect of music therapy on preoperative anxiety in elective surgery

    Diastolic blood pressure

    Measured: 6 months

  3. The effect of music therapy on preoperative anxiety in elective surgery

    mean arterial pressure

    Measured: 6 months

  4. The effect of music therapy on preoperative anxiety in elective surgery

    heart rate

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start8 Apr 2021
  3. Primary completion7 May 2021
  4. Study completion1 Jul 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813978
Sponsor's protocol ID
SNAMLEWAR
Status last verified
Jul 2021
First submitted
19 Mar 2021
Last updated
13 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.

    PubMed 29624026

  • Tulloch I, Rubin JS. Assessment and Management of Preoperative Anxiety. J Voice. 2019 Sep;33(5):691-696. doi: 10.1016/j.jvoice.2018.02.008. Epub 2018 May 9.

    PubMed 29753446

  • Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.

    PubMed 24731896

  • Lee WP, Wu PY, Lee MY, Ho LH, Shih WM. Music listening alleviates anxiety and physiological responses in patients receiving spinal anesthesia. Complement Ther Med. 2017 Apr;31:8-13. doi: 10.1016/j.ctim.2016.12.006. Epub 2017 Jan 7.

    PubMed 28434475

  • Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

    PubMed 3204199

  • Lemos MF, Lemos-Neto SV, Barrucand L, Vercosa N, Tibirica E. [Preoperative education reduces preoperative anxiety in cancer patients undergoing surgery: Usefulness of the self-reported Beck anxiety inventory]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):1-6. doi: 10.1016/j.bjan.2018.07.003. Epub 2018 Nov 3.

    PubMed 30401475

  • Franzoi MA, Goulart CB, Lara EO, Martins G. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial. Rev Lat Am Enfermagem. 2016 Dec 19;24:e2841. doi: 10.1590/1518-8345.1121.2841.

    PubMed 27992027

  • Jimenez-Jimenez M, Garcia-Escalona A, Martin-Lopez A, De Vera-Vera R, De Haro J. Intraoperative stress and anxiety reduction with music therapy: a controlled randomized clinical trial of efficacy and safety. J Vasc Nurs. 2013 Sep;31(3):101-6. doi: 10.1016/j.jvn.2012.10.002.

    PubMed 23953858

  • Wang Y, Dong Y, Li Y. Perioperative psychological and music interventions in elderly patients undergoing spinal anesthesia: effect on anxiety, heart rate variability, and postoperative pain. Yonsei Med J. 2014 Jul;55(4):1101-5. doi: 10.3349/ymj.2014.55.4.1101.

    PubMed 24954343

  • Ottaviani S, Bernard JL, Bardin T, Richette P. Effect of music on anxiety and pain during joint lavage for knee osteoarthritis. Clin Rheumatol. 2012 Mar;31(3):531-4. doi: 10.1007/s10067-011-1925-9. Epub 2011 Dec 30.

    PubMed 22207250

  • Ni CH, Tsai WH, Lee LM, Kao CC, Chen YC. Minimising preoperative anxiety with music for day surgery patients - a randomised clinical trial. J Clin Nurs. 2012 Mar;21(5-6):620-5. doi: 10.1111/j.1365-2702.2010.03466.x. Epub 2011 Feb 20.

    PubMed 21332853

  • Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: a report by the American Society of Anesthesiologist Task Force on Preoperative Fasting. Anesthesiology. 1999 Mar;90(3):896-905. doi: 10.1097/00000542-199903000-00034. No abstract available.

    PubMed 10078693

Questions about this trial

What is this clinical trial studying?

A study testing Music in people with Anxiety and Music, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.

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 2 inclusion and 5 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 13 Jul 2021. 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 Nepal. 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?

The effect of music therapy on preoperative anxiety in elective surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04813978, which also lists 12 linked publications.

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 13 Jul 2021.

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