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Completed

NCT Number: NCT06583668

The Effect of Therapeutic Story on Pain, Fear and Anxiety Levels

Aim: The aim of this study was to evaluate the effect of therapeutic story on pain, anxiety, fear and physiological parameters in children undergoing burn dressing.

Methods: A randomised controlled trial was conducted between April 2023 and June 2024 with 60 patients who were admitted to the burn unit of a hospital in Istanbul and met the inclusion criteria. Patients in the story group (n=30) were listened to the digitised story during burn dressing, while patients in the control group (n=30) did not receive any intervention other than routine care. Data were collected using the Descriptive Characteristics Form, Child Anxiety Scale-Situation Scale, Child Fear Scale, Wong-Barker Pain Scale, Parental Satisfaction Scale (VAS) and Physiological Parameters Form.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Burns Fear Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul- City Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • - To be between 3-6 years old,
  • Consideration of the first dressing of the child in the burn centre
  • 2nd degree superficial and deep burns (2nd degree burns requiring hospital treatment and high pain level)
  • Percentage of burns below 10 per cent (light sedation for children with burn injuries above 10 per cent)
  • Not having any chronic disease other than burns
  • The child's willingness to participate in the research
  • It is the absence of mental, communication problems and visual impairment.

Exclusion criteria

  • • The child's dressing has been done in a burn center before
  • Presence of 1st and 3rd degree burn areas
  • Burn percentage is over 10%

Treatment and study plan

Therapeutic Story

Other

Listening and watching the therapeutic story in digital media

Primary outcomes

  1. The effect of therapeutic history on pain

    Time frame: 15 month

    Wong Barker Pain Scale The Facial Expressions Rating Scale (Wong Baker) consists of six facial expressions. The facial expressions are graded as 'No pain=0 points' and 'Unbearable pain=10 points'. It is a scale based on the child's self-report and is suitable for use in children aged 3-18 years. In this scale, pain scores are given according to the numerical values given to the faces. The lowest score is '1' and the highest score is '5'. As the score obtained from the scale increases, pain tolerance decreases and as the score decreases, tolerance increases.

    This scale was used before, during and after the burn dressing.

  2. The effect of therapeutic history on fear

    Time frame: 15 month

    The scale is used to assess fear in children aged 4-10 years. The scale consists of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety).

    This scale was used before, during and after the burn dressing.

  3. The effect of therapeutic history anxiety

    Time frame: 15 month

    Child Anxiety Scale-Dispositional (CAS-D) Scale The Child Anxiety Scale-Dispositional (CAS-D) Scale aims to determine the anxiety levels of children aged 4-10 years. The CAS-D is shaped like a thermometer with a light bulb at the bottom and horizontal lines with intervals going upwards. In order to measure the state anxiety level, the child is asked to mark how he/she feels 'at the moment'. A transparent metre is placed over the child's rating on which ½ point increments are marked, then the ½ point increment is rounded up to the nearest number. The score can range from 0 to 10.It is determined that as the score value increases, the anxiety level increases, and as the score value decreases, the anxiety level decreases.

    This scale was used before, during and after the burn dressing.

Secondary outcomes

  1. The effect of the therapeutic story applied to children on parents' anxiety levels

    Time frame: 15 month

    State-Trait Anxiety Scale (STAI) The scale has 20 items and is graded between 1-4. The total score obtained from the scale is between 20-80. If the score obtained from the scales is low, it indicates that the anxiety of the individual is low, and if it is high, it indicates that the anxiety of the individual is high.

  2. The effect of therapeutic history on blood pressure/systolic -diastolic

    Time frame: 15 month

    Physiological Parameters Form Blood pressureof the patients were obtained with a form prepared by the investigator. Blood pressure; includes systolic and diastolic blood pressure valuesThis form was used before, during and after the burn dressing.

  3. The effect of therapeutic history on pulse rate

    Time frame: 15 month

    Physiological Parameters Form pulse rate of the patients were obtained with a form prepared by the investigator. This form was used before, during and after the burn dressing.

  4. The effect of therapeutic history on saturation levels

    Time frame: 15 month

    Physiological Parameters Form saturation levels of the patients were obtained with a form prepared by the investigator. This form was used before, during and after the burn dressing.

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

The Effect of Therapeutic Story on Pain, Fear and Anxiety Levels in Children With Burn Dressing

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 4, 2024
Registry last updated
Sep 19, 2024

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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