NCT03704961

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 10, 2018

Last Update Submit

October 17, 2018

Conditions

Outcome Measures

Primary 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.

    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.

    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 ).

    one hour after the patients were taken to the patient's room after the surgery

Secondary Outcomes (3)

  • Visual Analogue Scale

    Immediately after the listening was over

  • Wong-Baker Faces Pain Scale

    Immediately after the listening was over

  • State-Trait Anxiety Inventory for Children

    Immediately after the listening was over

Study Arms (3)

classical music

EXPERIMENTAL
Behavioral: music and audiobook listening

Turkish music

EXPERIMENTAL
Behavioral: music and audiobook listening

audiobook

EXPERIMENTAL
Behavioral: music and audiobook listening

Interventions

Turkish musicaudiobookclassical music

Eligibility Criteria

Age7 Years - 14 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
UludagU

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

January 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share