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

August 31, 2024 updated by: Niran Coban, Okan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul- City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Therapeutic Story group
I. Assessment:Before the burn dressing II. Assessment: During burn dressing II. Assessment: After burn dressing
Other: Therapeutic Story
Listening and watching the therapeutic story in digital media
No Intervention: Standard care
I. Assessment:Before the burn dressing II. Assessment: During burn dressing II. Assessment: After burn dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 month
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.
15 month
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 scale was developed by Ersig et al. (2013) and its Turkish validity and reliability was performed by Özalp Gerçeker et al. 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.

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 month
The effect of therapeutic history on blood pressure
Time Frame: 15 month
Physiological Parameters Form Blood pressureof the patients were obtained with a form prepared by the investigator. This form was used before, during and after the burn dressing.
15 month
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.
15 month
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.
15 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Investigators

  • Study Director: Niran ÇOBAN, Dr, Okan University
  • Study Director: Niran ÇOBAN, Dr, https://www.okan.edu.tr/

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 31, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 31, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSS0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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