Pain, PostoperativeNCT03704961
Effect of Auditory Distractions on Pediatric Postoperative Pain
A study testing music and audiobook listening in people with Pain, Postoperative, run by Uludag University.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- music and audiobook listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- -
About this study
Official title: Professor (Head of the Departmant of Nursing)
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.
- Conditions
- Pain, Postoperative
- Being tested
- music and audiobook listening
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music and audiobook listeningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| classical music | Experimental | Not described Receives: Behavioral: music and audiobook listening |
| Turkish music | Experimental | Not described Receives: Behavioral: music and audiobook listening |
| audiobook | Experimental | Not described Receives: Behavioral: music and audiobook listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one hour after the patients were taken to the patient's room after the surgery
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.
Measured: one hour after the patients were taken to the patient's room after the surgery
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 ).
Measured: one hour after the patients were taken to the patient's room after the surgery
Secondary outcomes (3)
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.
Measured: Immediately after the listening was over
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.
Measured: Immediately after the listening was over
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 ).
Measured: Immediately after the listening was over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study startJan 2017
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nurcan özyazıcıoğlu, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704961
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor (Head of the Departmant of Nursing)
- ClinicalTrials.gov ID
- NCT03704961
- Acronym / sponsor ID
- 1
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| classical music | Experimental | Behavioral: music and audiobook listening |
| Turkish music | Experimental | Behavioral: music and audiobook listening |
| audiobook | Experimental | Behavioral: music and audiobook listening |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music and audiobook listening | Behavioural | Turkish music, audiobook, classical music |
Primary outcome
Visual Analogue Scale
Time frame: one hour after the patients were taken to the patient's room after the surgery
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
Time frame: one hour after the patients were taken to the patient's room after the surgery
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
Time frame: one hour after the patients were taken to the patient's room after the surgery
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 ).
3 secondary outcomes
Visual Analogue Scale
Time frame: Immediately after the listening was over
Wong-Baker Faces Pain Scale
Time frame: Immediately after the listening was over
State-Trait Anxiety Inventory for Children
Time frame: Immediately after the listening was over
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing music and audiobook listening in people with Pain, Postoperative, run by Uludag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: one hour after the patients were taken to the patient's room after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.