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Effect of Preoperative Music on Anxiety

Primary Purpose

Music on Postoperative Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music
no music
Sponsored by
Ankara Diskapi Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Music on Postoperative Anxiety focused on measuring postoperative anxiety, State - Trait Anxiety Inventory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Diskapi Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

music

no music

Arm Description

The preference of the patients will be listened to preoperatively through the headphones.

preoperative music will not be listened

Outcomes

Primary Outcome Measures

STAI score
preoperative and postoperative STAI I and II score questions will be asked.
11-point numerical rating scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2019
Last Updated
September 24, 2019
Sponsor
Ankara Diskapi Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03816501
Brief Title
Effect of Preoperative Music on Anxiety
Official Title
The Effect of Favorite Music on Postoperative Anxiety and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Diskapi Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to postoperative anxiety.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music on Postoperative Anxiety
Keywords
postoperative anxiety, State - Trait Anxiety Inventory

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
music
Arm Type
Other
Arm Description
The preference of the patients will be listened to preoperatively through the headphones.
Arm Title
no music
Arm Type
Other
Arm Description
preoperative music will not be listened
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
The preference of the patients will be listened to preoperatively through the headphones
Intervention Type
Other
Intervention Name(s)
no music
Intervention Description
the patients will not be listened
Primary Outcome Measure Information:
Title
STAI score
Description
preoperative and postoperative STAI I and II score questions will be asked.
Time Frame
24 hours
Title
11-point numerical rating scale (NRS)
Description
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Diskapi Teaching and Research Hospital
City
Ankara
State/Province
Altindag
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Preoperative Music on Anxiety

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