Back to resultsEffect of Auditory Distractions on Pediatric Postoperative Pain
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
music and audiobook listening
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- patients aged between 7-14 years old,
- staying in a single room,
- those for whom a surgical procedure for inguinal or abdominal region had been planned,
- in the first hour of postoperative period,
- free of any problem that prevents expression of the post-operative pain,
- free of hearing problems,
- having undergone same analgesia protocol; were included in the study.
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
classical music
Turkish music
audiobook
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Visual Analog Scale (VAS): It is a straight line with a length of 10 cm. On the '0 line', there is "no pain" and on the '10 line', it is "unbearable pain". The child is asked to mark the place indicating the severity of his/her pain.
Wong-Baker Faces Pain Scale
This was developed by Donna Lee Wong and Connie Morain Baker. This scale is used to determine the level of pain in children over three years of age. The severity of pain is determined by the child with choosing the face that describes the child's pain level on the scale starting with the smiling face and ending with the crying face.
State-Trait Anxiety Inventory for Children
This was developed by Spielberger (1973). It is a three-point Likert-type scale. The validity and reliability of the scale were performed by Özusta (1993).The scale consists of two parts as; 'state anxiety scale' and 'trait anxiety scale'. It consists of 40 items in total, 20 items in each part. The STAI-C was adapted from an adult scale and is also known as the "How I Feel Questionnaire". ıt comprises separate self-report scales for measuring two distinct anxiety concepts: state anxiety (S-Anxiety) and trait anxiety (T- Anxiety). The 20- item scale asseses a number of symptoms of anxiety such as "I get a funny feeling in my stomach" and "I am checking one of three alternatives that describes him or her best or indicates frequency of occurrence ( 1 = almost never; 2 = sometimes; 3 = often ).
Secondary Outcome Measures
Visual Analogue Scale
Visual Analog Scale (VAS): It is a straight line with a length of 10 cm. On the '0 line', there is "no pain" and on the '10 line', it is "unbearable pain". The child is asked to mark the place indicating the severity of his/her pain.
Wong-Baker Faces Pain Scale
This was developed by Donna Lee Wong and Connie Morain Baker. This scale is used to determine the level of pain in children over three years of age. The severity of pain is determined by the child with choosing the face that describes the child's pain level on the scale starting with the smiling face and ending with the crying face.
State-Trait Anxiety Inventory for Children
This was developed by Spielberger (1973). It is a three-point Likert-type scale. The validity and reliability of the scale were performed by Özusta (1993).The scale consists of two parts as; 'state anxiety scale' and 'trait anxiety scale'. It consists of 40 items in total, 20 items in each part. The STAI-C was adapted from an adult scale and is also known as the "How I Feel Questionnaire". ıt comprises separate self-report scales for measuring two distinct anxiety concepts: state anxiety (S-Anxiety) and trait anxiety (T- Anxiety). The 20- item scale asseses a number of symptoms of anxiety such as "I get a funny feeling in my stomach" and "I am checking one of three alternatives that describes him or her best or indicates frequency of occurrence ( 1 = almost never; 2 = sometimes; 3 = often ).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03704961
Brief Title
Effect of Auditory Distractions on Pediatric Postoperative Pain
Official Title
Professor (Head of the Departmant of Nursing)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University
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
The aim of the study was to determine the effect of different auditorial methods of attention distraction on postoperative pain and anxiety in children. Three group pre and post-test randomized clinical trial.The data were collected using the Socio-demographic Data Form for Child and Parent, Visual Analogue Scale, Wong-Baker Faces Pain Scale and State-Trait Anxiety Inventory for Children. The investigators found that listening to classical music, Turkish music and audiobook methods played an effective role in decreasing postoperative pain and anxiety state in children in the three groups in the study. As a result, investigators showed that different auditorial attention distraction methods had a decreasing effect on postoperative pain and anxiety in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
classical music
Arm Type
Experimental
Arm Title
Turkish music
Arm Type
Experimental
Arm Title
audiobook
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
music and audiobook listening
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analog Scale (VAS): It is a straight line with a length of 10 cm. On the '0 line', there is "no pain" and on the '10 line', it is "unbearable pain". The child is asked to mark the place indicating the severity of his/her pain.
Time Frame
one hour after the patients were taken to the patient's room after the surgery
Title
Wong-Baker Faces Pain Scale
Description
This was developed by Donna Lee Wong and Connie Morain Baker. This scale is used to determine the level of pain in children over three years of age. The severity of pain is determined by the child with choosing the face that describes the child's pain level on the scale starting with the smiling face and ending with the crying face.
Time Frame
one hour after the patients were taken to the patient's room after the surgery
Title
State-Trait Anxiety Inventory for Children
Description
This was developed by Spielberger (1973). It is a three-point Likert-type scale. The validity and reliability of the scale were performed by Özusta (1993).The scale consists of two parts as; 'state anxiety scale' and 'trait anxiety scale'. It consists of 40 items in total, 20 items in each part. The STAI-C was adapted from an adult scale and is also known as the "How I Feel Questionnaire". ıt comprises separate self-report scales for measuring two distinct anxiety concepts: state anxiety (S-Anxiety) and trait anxiety (T- Anxiety). The 20- item scale asseses a number of symptoms of anxiety such as "I get a funny feeling in my stomach" and "I am checking one of three alternatives that describes him or her best or indicates frequency of occurrence ( 1 = almost never; 2 = sometimes; 3 = often ).
Time Frame
one hour after the patients were taken to the patient's room after the surgery
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analog Scale (VAS): It is a straight line with a length of 10 cm. On the '0 line', there is "no pain" and on the '10 line', it is "unbearable pain". The child is asked to mark the place indicating the severity of his/her pain.
Time Frame
Immediately after the listening was over
Title
Wong-Baker Faces Pain Scale
Description
This was developed by Donna Lee Wong and Connie Morain Baker. This scale is used to determine the level of pain in children over three years of age. The severity of pain is determined by the child with choosing the face that describes the child's pain level on the scale starting with the smiling face and ending with the crying face.
Time Frame
Immediately after the listening was over
Title
State-Trait Anxiety Inventory for Children
Description
This was developed by Spielberger (1973). It is a three-point Likert-type scale. The validity and reliability of the scale were performed by Özusta (1993).The scale consists of two parts as; 'state anxiety scale' and 'trait anxiety scale'. It consists of 40 items in total, 20 items in each part. The STAI-C was adapted from an adult scale and is also known as the "How I Feel Questionnaire". ıt comprises separate self-report scales for measuring two distinct anxiety concepts: state anxiety (S-Anxiety) and trait anxiety (T- Anxiety). The 20- item scale asseses a number of symptoms of anxiety such as "I get a funny feeling in my stomach" and "I am checking one of three alternatives that describes him or her best or indicates frequency of occurrence ( 1 = almost never; 2 = sometimes; 3 = often ).
Time Frame
Immediately after the listening was over
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged between 7-14 years old,
staying in a single room,
those for whom a surgical procedure for inguinal or abdominal region had been planned,
in the first hour of postoperative period,
free of any problem that prevents expression of the post-operative pain,
free of hearing problems,
having undergone same analgesia protocol; were included in the study.
Exclusion Criteria:
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Auditory Distractions on Pediatric Postoperative Pain
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