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Trial registered on ANZCTR


Registration number
ACTRN12623001299695
Ethics application status
Approved
Date submitted
14/06/2023
Date registered
13/12/2023
Date last updated
13/12/2023
Date data sharing statement initially provided
13/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of perioperative music therapy and lavender on anxiety and satisfaction in adult patients undergoing orthopedic hand surgery with regional anaesthesia
Scientific title
The effect of perioperative music therapy and lavender on anxiety and satisfaction in adult patients undergoing orthopedic hand surgery with regional anaesthesia
Secondary ID [1] 309895 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 330357 0
patient satisfaction 330358 0
Condition category
Condition code
Alternative and Complementary Medicine 327199 327199 0 0
Herbal remedies
Alternative and Complementary Medicine 327200 327200 0 0
Other alternative and complementary medicine
Anaesthesiology 327203 327203 0 0
Pain management
Surgery 327204 327204 0 0
Other surgery
Mental Health 327956 327956 0 0
Anxiety
Public Health 327957 327957 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects of the intervention arms receive a recorded music or a lavender eye pillow or both of them.
The interventions will be started to apply in the operating room after the patient lies on the operating table. The interventions will be removed at the end of the surgery before patient is taken to the postoperative care unit. The approximate duration of the the intervention is approximately 1 hour. Anesthesiologist records will be used to monitor.
The music (soothing playlist) was selected and recorded by a master of musician from our university and music will be heard through an on-ear headphone connected to a digital music player. The purple Lavender Aromatherapy Eye Pillow filled with lavender flowers will be placed over both eyes of the patients till the end of the surgery by the anesthesiologist.
In the third intervention group both the patient will listen to music through the ear headphones and a lavender eye pillow will be placed over both the eyes during the procedure.
All the interventions will be provided by the anesthesiologist and pain specialists.
Intervention code [1] 326320 0
Treatment: Other
Comparator / control treatment
Control group will have no treatment or intervention. They will not listen to music and purple Lavender Aromatherapy Eye Pillow will not be placed over the eyes of the patient. Our standard anesthesia and operation procedure will be performed.
Control group
Active

Outcomes
Primary outcome [1] 335079 0
The primary outcome parameter is anxiety and will be assessed by State-trait Anxiety Inventory (STAI) test.
Timepoint [1] 335079 0
baseline is one day before the operation
6 hours after the operation
Primary outcome [2] 335080 0
the primary outcome 2: pateint satisfaction will be assessed by using 40-item Quality of Recovery (QoR) survey
Timepoint [2] 335080 0
Baseline one day before surgery,
5 days after operation
Secondary outcome [1] 422992 0
Secondary outcome is pain intensity assessed by Visual Analog Scale (VAS)
Timepoint [1] 422992 0
It will be measured 1 hour postoperatively
Secondary outcome [2] 429844 0
Heart Rate measured using electrocadiography
Timepoint [2] 429844 0
before the anaesthesia and then every 15 minutes to the end of the operation
Secondary outcome [3] 429845 0
systolic arterial pressure (SAP) measured using automated blood pressure monitor
Timepoint [3] 429845 0
before the anaesthesia and then every 15 minutes to the end of the operation
Secondary outcome [4] 429846 0
diastolic arterial pressure (DAP) measured using automated blood pressure monitor
Timepoint [4] 429846 0
before the anaesthesia and then every 15 minutes to the end of the operation
Secondary outcome [5] 429847 0
mean arterial pressure (MAP) measured using automated blood pressure monitor
Timepoint [5] 429847 0
before the anaesthesia and then every 15 minutes to the end of the operation
Secondary outcome [6] 429868 0
oxygen saturation (O2sat) measured using pulse oximeter
Timepoint [6] 429868 0
before the anaesthesia and then every 15 minutes to the end of the operation

Eligibility
Key inclusion criteria
Inclusion criteria were: (1) American Society of Anesthesiologists (ASA) grade I–II (2) of at least 18 years of age (3) has no smell nor auditory impairment, (4) conscious, able to communicate with the researchers (5) being at least primary school graduates
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were (1) patient refusal (2) allergy or sensitivity to lavender (3) respiratory problems (4)speech and auditory disabilities (5)history of neurological or psychological illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients meeting the inclusion criteria were randomized in four groups, by using Central randomisation by computer either the music group (MG), the lavender group (LG), both the music and lavender group (ML) or the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by using computer-generated randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study data were analyzed with the SPSS (Statistical Package for Social Science, version24). In this study, descriptive statistics ( mean and standard deviation) were used to examine the general characteristics of the groups. Differences between groups were evaluated by ANOVA test. Pearson Correlation test was applied to determine the relationships between the measurements. Moreover, dependent groups t-test was used to analyze the variation of certain measurements (HR, SAP, DAP, MAP, 02SAT) between the 1st minute and the 15th minute. For the significance level of the statistical results, p < 0.05 was used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/02/2021
Date of last participant enrolment
Anticipated
Actual
5/04/2022
Date of last data collection
Anticipated
Actual
11/04/2022
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 25593 0
Turkey
State/province [1] 25593 0
IZMIR

Funding & Sponsors
Funding source category [1] 314080 0
Self funded/Unfunded
Name [1] 314080 0
Zeynep Cagiran
Country [1] 314080 0
Turkey
Primary sponsor type
Individual
Name
Zeynep Cagiran
Address
Ege University Medical Faculty, Department of Anesthesiology and Reanimation Bornova, Izmir 35100
Country
Turkey
Secondary sponsor category [1] 315989 0
None
Name [1] 315989 0
none
Address [1] 315989 0
none
Country [1] 315989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313218 0
Institutional Review Board of the Ege University Faculty of Medicine
Ethics committee address [1] 313218 0
Kazimdirik mah. Ege University Faculty of Medicine Anesthesiology and Reanimation Department Bornova Izmir 35100
Ethics committee country [1] 313218 0
Turkey
Date submitted for ethics approval [1] 313218 0
01/03/2019
Approval date [1] 313218 0
20/03/2019
Ethics approval number [1] 313218 0
20.03.2019-19-3.1T/67

Summary
Brief summary
Purpose: Perioperative anxiety is a common cause of physchiological stress for patients undergoing surgery under regional anesthesia. In recent years, using complementary and alternative therapies such as acupuncture, aromatherapy, music therapy, hypnotism have become more attractive. Aromatherapy and music therapy are simple, cheap, non-invasive, safe and low-cost methods of reducing operative anxiety. This research was aimed to evaluate the effects of music intervention in the style of nature sounds and a lavender-scented eye pillow placed on the eyelids of patients undergoing the similar type of operation under regional anesthesia on patient anxiety and patient satisfaction.
Methods: In this prospective, randomized study 120 patients were divided randomly into 4 groups. the music group (MG), the lavender group (LG), both the music and lavender group (ML), the control group. Primary outcome is self rated anxiety level assessed by State-Trait Anxiety Inventory(STAI) test and patient satisfaction assessed by The Quality of Recovery Score (QoR-40). Secondary outcomes are pain measured by Visual analog scale (VAS), vital parameters such as heart rate, blood pressure and respiratory rate and oxygen saturation,
Ethical Considerations: The study was carried out in accordance with the Declaration of Helsinki, after obtaining the Institutional Review Board of the Ege University Faculty of Medicine.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127382 0
Dr Zeynep Cagiran
Address 127382 0
Ege University Faculty of Medicine Anaesthesiology and Reanimation Department Bornova , Izmir 35100
Country 127382 0
Turkey
Phone 127382 0
+90 5319921423
Fax 127382 0
Email 127382 0
[email protected]
Contact person for public queries
Name 127383 0
Zeynep Cagiran
Address 127383 0
Ege University Faculty of Medicine Anaesthesiology and Reanimation Department Bornova , Izmir 35100
Country 127383 0
Turkey
Phone 127383 0
+90 5319921423
Fax 127383 0
Email 127383 0
[email protected]
Contact person for scientific queries
Name 127384 0
Zeynep Cagiran
Address 127384 0
Ege University Faculty of Medicine Anaesthesiology and Reanimation Department Bornova , Izmir 35100
Country 127384 0
Turkey
Phone 127384 0
+90 5319921423
Fax 127384 0
Email 127384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification; individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no-end date determined
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
It is available for any purpose
How or where can data be obtained?
All data can be obtained from the principal investigator by email ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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