- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816501
Effect of Preoperative Music on Anxiety
The Effect of Favorite Music on Postoperative Anxiety and Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) I and II.
117 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into two groups as preoperative music played and not played. The list of patients listening to the music will be played through the headphones which are the preference of the patients. The postoperative STAI questionnaire will be applied again. results will be evaluated statistically
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altindag
-
Ankara, Altindag, Turkey
- Diskapi Teaching and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- inguinal hernia surgery
- speak Turkish language
Exclusion Criteria:
- Patients with dementia and psychiatric disorders
- anxiolytic and psychiatric drug users
- patients without written consent
- poor vision,
- significant hearing loss,
- active opioid use,
- unwillingness to participate in the study
- unwillingness to listening to music
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: music
The preference of the patients will be listened to preoperatively through the headphones.
|
The preference of the patients will be listened to preoperatively through the headphones
|
Other: no music
preoperative music will not be listened
|
the patients will not be listened
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
11-point numerical rating scale (NRS)
Time Frame: 24 hours
|
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
|
24 hours
|
STAI score
Time Frame: 24 hours
|
preoperative and postoperative STAI I and II score questions will be asked.
|
24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Anxiety
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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