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CancerNCT03269929

Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety

A study testing Music therapy and Midazolam in people with Cancer, run by Universitas Indonesia at 1 site in Indonesia.

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

This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Cancer
What is being tested?
Music therapy and Midazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndonesia
Study dates
1 Jan 2017to 1 Jul 2017
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Woman aged 18-65 years old
  • Undergoing one day care brachtherapy with spinal anesthesia
  • American Society of Anesthesiologist (ASA) physical status of I-III
  • Agreed to participate in this study and signed informed consent
  • Able to read, write, and speak in Indonesian language.

Who cannot join

  • Subjects with severe hearing impairment
  • Subjects with cognitive/mental impairment based on medical record
  • Subjects with previous routine use of antipsychotic and benzodiazepine drug
  • Subjects with prior heart disease or uncontrolled hypertension.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Central National Hospital

    Central Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Comparison Between Music Therapy and Intravenous Midazolam 0,02 mg/kgBW in Reducing Preoperative Anxiety: Study on Patient Undergoing Brachytherapy With Spinal Anesthesia

This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia

Read the detailed description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Intravenous (IV) cannula had been set and The Amsterdam Preoperative Anxiety and Information (APAIS) score questionnaire was filled by the subject. Blood pressure, pulse rate, and mean arterial pressure were recorded. Subjects were then randomized into two groups (music therapy and midazolam). In music therapy group, subjects listened to music using headphone attached to music player for 30 minutes. Music player has been filled with variety of slow beat songs (60 - 80 BPM), including instrumental, pop, jazz, classical, and so forth. In midazolam group, subjects was given intravenous midazolam 0,02 mg/kgBW injection without listening to music. After injection, subjects are allowed to rest or sleep for 30 minutes. After intervention, APAIS score was filled by subjects with blood pressure, pulse rate, and mean arterial pressure recorded again. Subjects then were moved to brachytherapy room.

Conditions
Cancer
Being tested
Music therapy, Midazolam
Medical subject headings
Neoplasms

What participants receive

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

  • Music therapyOther

    Subjects listened to music for 30 minutes before undergoing brachytherapy with spinal anesthesia

  • MidazolamDrug

    Subjects received intravenous midazolam 0,02 mg/kgBW injection before undergoing brachytherapy with spinal anesthesia

Study groups in NCT03269929
Study groupRoleWhat they receive
Music therapyExperimentalNot described
Receives: Other: Music therapy
MidazolamActive comparatorNot described
Receives: Drug: Midazolam

What is being measured

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

  1. APAIS score

    Measured: Day 1

  2. Blood pressure

    Measured: Day 1

  3. Pulse rate

    Measured: Day 1

  4. Mean Arterial Pressure

    Measured: Day 1

Timeline

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

  1. First posted1 Sep 2017
  2. Study start1 Jan 2017
  3. Primary completion31 Mar 2017
  4. Study completion1 Jul 2017

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03269929
Sponsor's protocol ID
IndonesiaUAnes018
Status last verified
Aug 2017
First submitted
19 Jul 2017
Last updated
1 Sep 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mohd Fahmi Z, Lai LL, Loh PS. Validation of the Malay version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Med J Malaysia. 2015 Aug;70(4):243-8.

    PubMed 26358022

  • Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.

    PubMed 11207465

  • Hyde R, Bryden F, Asbury AJ. How would patients prefer to spend the waiting time before their operations? Anaesthesia. 1998 Feb;53(2):192-5. doi: 10.1046/j.1365-2044.1998.00268.x.

    PubMed 9534647

  • Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.

    PubMed 23740695

  • Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007 Jan;31(1):52-79. doi: 10.1177/0145445506295055.

    PubMed 17179531

  • Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013 Summer;13(2):214-23.

    PubMed 23789008

  • Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.

    PubMed 18772216

  • Kain ZN, Sevarino F, Pincus S, Alexander GM, Wang SM, Ayoub C, Kosarussavadi B. Attenuation of the preoperative stress response with midazolam: effects on postoperative outcomes. Anesthesiology. 2000 Jul;93(1):141-7. doi: 10.1097/00000542-200007000-00024.

    PubMed 10861157

  • Marwick C. Music therapists chime in with data on medical results. JAMA. 2000 Feb 9;283(6):731-3. No abstract available.

    PubMed 10683042

  • Kamer S, Ozsaran Z, Celik O, Bildik O, Yalman D, Bolukbasi Y, Haydaroglu A. Evaluation of anxiety levels during intracavitary brachytherapy applications in women with gynecological malignancies. Eur J Gynaecol Oncol. 2007;28(2):121-4.

    PubMed 17479673

  • Wetsch WA, Pircher I, Lederer W, Kinzl JF, Traweger C, Heinz-Erian P, Benzer A. Preoperative stress and anxiety in day-care patients and inpatients undergoing fast-track surgery. Br J Anaesth. 2009 Aug;103(2):199-205. doi: 10.1093/bja/aep136. Epub 2009 May 30.

    PubMed 19483203

  • Mitchell M. Influence of gender and anaesthesia type on day surgery anxiety. J Adv Nurs. 2012 May;68(5):1014-25. doi: 10.1111/j.1365-2648.2011.05801.x. Epub 2011 Aug 2.

    PubMed 21806671

  • Cooke M, Chaboyer W, Schluter P, Hiratos M. The effect of music on preoperative anxiety in day surgery. J Adv Nurs. 2005 Oct;52(1):47-55. doi: 10.1111/j.1365-2648.2005.03563.x.

    PubMed 16149980

  • 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.

    PubMed 19388893

  • Leardi S, Pietroletti R, Angeloni G, Necozione S, Ranalletta G, Del Gusto B. Randomized clinical trial examining the effect of music therapy in stress response to day surgery. Br J Surg. 2007 Aug;94(8):943-7. doi: 10.1002/bjs.5914.

    PubMed 17636513

Questions about this trial

What is this clinical trial studying?

A study testing Music therapy and Midazolam in people with Cancer, run by Universitas Indonesia at 1 site in Indonesia.

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 5 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 1 Sep 2017. 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 Indonesia. 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?

APAIS score (time frame: Day 1). The study lists 4 primary outcomes in all. 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 NCT03269929, which also lists 27 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 1 Sep 2017.

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