Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000406707
Ethics application status
Approved
Date submitted
29/03/2013
Date registered
12/04/2013
Date last updated
17/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of music, white noise, and ambient noise on sedation and anxiety in patients operated under spinal anesthesia
Scientific title
The effects of music, white noise, and ambient noise on sedation and anxiety in patients undergoing general surgical, urological and orthopedic operations under spinal anesthesia
Secondary ID [1] 282208 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perioperative anxiety 288727 0
Anxiety and sedation for urological and orthopedic operations 288728 0
Condition category
Condition code
Anaesthesiology 289083 289083 0 0
Other anaesthesiology
Mental Health 289200 289200 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
25 cases from each group, amounting to 75 patients, were included in the assessments.
Group O: : Ambient noise in the operating room that is because of working, staff etc is usually seen at surgery center. The duration that participants listen to this noise is continuously after induction of anaesthesia, until the end of the operation. Also the patients is that were brought into the operating room, listened to the amplified ambient noise with the aid of a headset. Because of the noise was set at a comfortable audio level.
Ambient noise in the operating room was augmented using an amplifier [Mini Amplifier, No: 9988, Ekincioglu (Registered Trademark), Istanbul], and the patients used a headset [SN-802, Snopy (Registered Trademark)] to listen to the ambient noise, during, and after the operation (until the end of the operation, not at the recovery room).

Group B: The patients selected one compact disc (CD) among three white noise CDs (Babling Brook, Distant Thunderstorm, Restful Rain) provided from Pure White Noise(Registered Trademark) Co. USA and listened during preoperative, postspinal, intraoperative, and postoperative periods (the duration that participants listen to the white noise after induction of anaesthesia and continues until 30 minutes post-operatively). Also Group B patients started to listen to white noise using a headset connected to a computerized system. Because of their most comfortable sound level was maintained.

Group M: Numerous musical pieces in the MP3 format were loaded on an Acer (Registered Trademark) laptop. In compliance with the patients’ wishes, the patients listened to the songs from their favorite playlists using the same headset during preoperative, postspinal, intraoperative, and postoperative periods (the duration that participants listen to the white noise after induction of anaesthesia and continues until 30 minutes post-operatively). Group M started to listen to songs from a preprepared playlist using a headset connected to a computerized system. Why that is their most comfortable sound level was maintained.

When the patients entered into the waiting room for the first time, their state of anxiety, and sedation was evaluated using VAS (Visual Anxiety Scale: 0 = very calm; 10 = very anxious), STAI (The State-Trait Anxiety Inventory) and OAA/S (Observer's Assessment of Alertness/Sedation Scale) scale scoring systems. OAA/S was graded as follows:
The patient (1) gives a response only when his /her shoulders prodded, (2) responds only after calling his/her name loudly, (3) responds slowly after calling his/her name with normal tone (4) responds normally when his/her name is spoken with normal tone. STAI consists of two different parts, as STAI-TA (Trait Anxiety Inventory) and STAI-SA (State Anxiety Inventory). The first test determines baseline anxiety level and the second one indicates anxiety level generated by environmental changes. This test requires from the patients to respond to the 40-item questionnaire. Twenty items were prepared for STAI-TA, and 20 items for STAI-SA scales. For each domain, the allocated scores vary between 20 and 80 points, representing the highest and the lowest levels of anxiety, respectively. In our study, STAI-TA test results were evaluated preoperatively. Assessments of STAI-SA tests were performed during preoperative period, before induction of prespinal anesthesia, 5 minutes before surgical intervention, and at 30 minutes recovery period.
In the preoperative waiting room, Group B patients started to listen to white noise, while Group M listened to songs from a preprepared playlist using a headset connected to a computerized system. Their most comfortable sound level was maintained. All groups were asked about their educational level, their tastes in music, and frequency of listening to music. Their responses to the questions were recorded.
When patients were brought to the regional anesthesia unit, their electrocardiogram (EKGs), non-invasive blood pressure test results, and saturation of peripheral oxygen (SpO2) levels were monitored and their preoperative baseline values were recorded. Before induction of spinal anesthesia, in addition to the measurements of hemodynamic parameters, VAS, STAI-SA, and OAA/S tests were reapplied to the patients. The patients stopped listening to musical pieces or white noise during institution of spinal anesthesia. After maintenance of adequate hydration, spinal anesthesia was achieved with administration of 10-15mg, 0.5% hyperbaric bupivacaine. All patients received 25microgram/kg IV midazolam after induction of spinal anesthesia. Their hemodynamic parameters, VAS and OAA/S scores were evaluated and recorded at 5-minute intervals before they were taken into the operating room. Five minutes before lying on the operating table, their STAI-SA scores were reevaluated for the third time.
The patients were brought into the operating room, and underwent standard monitoring procedures. O2 was delivered through a nasal cannula at a rate of 3 L/min as patients in Group O listened to the amplified ambient noise with the aid of a headset. The noise was set at a comfortable audio level.
During the intraoperative period, heart rate, diastolic/systolic blood pressure (mean blood pressure), SpO2, respiratory rate, VAS (0-10), and OAA/S (1-5) measurements were performed at 5-minute intervals. All patients received uninterrupted IV midazolam infusion at a dose of 0.5microgram/kg/min during the duration of the operation.
At the end of the operation, IV infusion of midazolam was stopped. The duration of anesthesia was determined and recorded as the time interval between the induction of anesthesia to the end of the operation. The patients were transferred to the postoperative recovery room and monitored for 30 minutes for hemodynamic parameters, level of sedation, and occurrence of adverse effects. In the recovery room, vital signs, OAA/S, and VAS scores were evaluated at 5-minute intervals. Patients in Groups M and B continued to listen to their favorite songs, and STAI-SA scores were reevaluated 30 minutes later for the fourth time. Patient satisfaction with this application was evaluated (1: Poor, 2: Moderate, 3: Good, 4: Excellent) before their transfer to their wards.
Intervention code [1] 286825 0
Treatment: Other
Comparator / control treatment
The patients were divided into three groups. Patients listened to ambient noise (Group O), white noise (Group B) or music (Group M).
Control group
Active

Outcomes
Primary outcome [1] 289193 0
Effects of music, white, and ambient (background) noise on anxiety, and sedation.
Their state of anxiety, and sedation was evaluated using VAS (Visual Anxiety Scale), STAI (The State-Trait Anxiety Inventory), STAI-SA (State Anxiety Inventory) and OAA/S (Observer's Assessment of Alertness/Sedation Scale) scale scoring systems.
Timepoint [1] 289193 0
1-STAI-TA test; for once preoperatively.
2-STAI-SA tests; during preoperative period, before induction of spinal anesthesia, 5 minutes before surgical intervention and 30 minutes into the recovery period.
3-VAS and OAA/S: When the patients entered into the waiting room, before induction of spinal anesthesia, at 5-minute intervals before they were taken into the operating room and during the intraoperative period. In the recovery room OAA/S and VAS scores were evaluated at 5-minute intervals for 30 minutes.
Secondary outcome [1] 302006 0
heart rate as assessed by electrocardiogram (EKGs)
Timepoint [1] 302006 0
Secondary timepoint are from patient arrived the regional anesthesia unit to until 30 minutes post-operatively at 5-minute intervals.
Secondary outcome [2] 302215 0
non-invasive blood pressure
Timepoint [2] 302215 0
Secondary timepoint are from patient arrived the regional anesthesia unit to until 30 minutes post-operatively at 5-minute intervals.
Secondary outcome [3] 302216 0
saturation of peripheral oxygen (SpO2) levels by using pulse oximeter
Timepoint [3] 302216 0
Secondary timepoint are from patient arrived the regional anesthesia unit to until 30 minutes post-operatively at 5-minute intervals.

Eligibility
Key inclusion criteria
1-American Society of Anesthesiologists (ASA) (ASA class I-II

2-Patients who underwent surgical, urological, and orthopedic operations.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Contraindications to regional anesthesia
2-Hearing impairment
3-History of psychiatric drug use
4-Hepatic, renal, and hormonal dysfunction, and serious cardiopulmonary disorders.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2010
Actual
4/01/2010
Date of last participant enrolment
Anticipated
7/06/2010
Actual
10/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 4960 0
Turkey
State/province [1] 4960 0
samsun

Funding & Sponsors
Funding source category [1] 286971 0
Self funded/Unfunded
Name [1] 286971 0
nazan koylu ilkaya
Country [1] 286971 0
Turkey
Primary sponsor type
Individual
Name
nazan koylu ilkaya
Address
ondokuz mayis university faculty of medicine
kurupelit/atakum/samsun/turkey
postcode: 55139
Country
Turkey
Secondary sponsor category [1] 285761 0
Individual
Name [1] 285761 0
cengiz kaya
Address [1] 285761 0
ondokuz mayis university faculty of medicine
kurupelit/atakum/samsun/turkey
postcode: 55139
Country [1] 285761 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289020 0
19 Mayis University Ethics Committee of Clinical Investigations
Ethics committee address [1] 289020 0
Ethics committee country [1] 289020 0
Turkey
Date submitted for ethics approval [1] 289020 0
Approval date [1] 289020 0
Ethics approval number [1] 289020 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38838 0
Dr nazan koylu ilkaya
Address 38838 0
ondokuz mayis university faculty of medicine
kurupelit/atakum/samsun/turkey
postcode: 55139
Country 38838 0
Turkey
Phone 38838 0
+90 5353696195
Fax 38838 0
Email 38838 0
[email protected]
Contact person for public queries
Name 38839 0
cengiz kaya
Address 38839 0
ondokuz mayis university faculty of medicine
kurupelit/atakum/samsun/turkey
postcode: 55139
Country 38839 0
Turkey
Phone 38839 0
+90 03623121919
Fax 38839 0
Email 38839 0
[email protected]
Contact person for scientific queries
Name 38840 0
cengiz kaya
Address 38840 0
ondokuz mayis university faculty of medicine
kurupelit/atakum/samsun/turkey
postcode: 55139
Country 38840 0
Turkey
Phone 38840 0
+90 03623121919
Fax 38840 0
Email 38840 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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