Clinical trial · Interventional
Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety
Comparison Between Music Therapy and Intravenous Midazolam 0,02 mg/kgBW in Reducing Preoperative Anxiety: Study on Patient Undergoing Brachytherapy With Spinal Anesthesia
NCT03269929CI-TRIAL-00029391completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Midazolam | Drug | — | UNRESOLVED |
| Music therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Music therapy
- interventionNames
- Other: Music therapy
- type
- ACTIVE_COMPARATOR
- label
- Midazolam
- interventionNames
- Drug: Midazolam
Primary outcomes (4)
- measure
- APAIS score
- timeFrame
- Day 1
- measure
- Blood pressure
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (27)
- BACKGROUNDMohd 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. PMID 26358022
- BACKGROUNDCaumo 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. PMID 11207465
- BACKGROUNDHyde 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. PMID 9534647
- BACKGROUNDBradt 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. PMID 23740695
- BACKGROUNDWright 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. PMID 17179531
- BACKGROUNDGriffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013 Summer;13(2):214-23. PMID 23789008
- BACKGROUNDSun 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. PMID 18772216
- BACKGROUNDKain 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.