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Completed

NCT Number: NCT03704961

Effect of Auditory Distractions on Pediatric Postoperative Pain

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

music and audiobook listening

Behavioral

Primary outcomes

  1. 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.

  2. 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.

  3. 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 ).

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: Immediately after the listening was over

    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.

  2. Wong-Baker Faces Pain Scale

    Time frame: Immediately after the listening was over

    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.

  3. State-Trait Anxiety Inventory for Children

    Time frame: Immediately after the listening was over

    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 ).

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

Professor (Head of the Departmant of Nursing)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2018
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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