Clinical trial NCT06583668: The Effect of Therapeutic Story on Pain, Fear and Anxiety Levels
Official title: The Effect of Therapeutic Story on Pain, Fear and Anxiety Levels in Children With Burn Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Burns
Fear
Anxiety
Keywords: Anxiety
Burn
Child
Pain
Fear
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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%

Primary outcomes:
measure: The effect of therapeutic history on pain
timeFrame: 15 month
measure: The effect of therapeutic history on fear
timeFrame: 15 month
measure: The effect of therapeutic history anxiety
timeFrame: 15 month
Secondary outcomes:
measure: The effect of the therapeutic story applied to children on parents' anxiety levels
timeFrame: 15 month
measure: The effect of therapeutic history on blood pressure/systolic -diastolic
timeFrame: 15 month
measure: The effect of therapeutic history on pulse rate
timeFrame: 15 month
measure: The effect of therapeutic history on saturation levels
timeFrame: 15 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul- City Hospital
Study officials:
affiliation: Okan University
name: Niran ÇOBAN, Dr
role: STUDY_DIRECTOR
affiliation: https://www.okan.edu.tr/
name: Niran ÇOBAN, Dr
role: STUDY_DIRECTOR
References:
citation: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
citation: Farzan R, Parvizi A, Haddadi S, Sadeh Tabarian M, Jamshidbeigi A, Samidoust P, Ghorbani Vajargah P, Mollaei A, Takasi P, Karkhah S, Firooz M, Hosseini SJ. Effects of non-pharmacological interventions on pain intensity of children with burns: A systematic review and meta-analysis. Int Wound J. 2023 Sep;20(7):2898-2913. doi: 10.1111/iwj.14134. Epub 2023 Mar 1.
citation: Chester SJ, Stockton K, De Young A, Kipping B, Tyack Z, Griffin B, Chester RL, Kimble RM. Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):223. doi: 10.1186/s13063-016-1346-9.
citation: Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019.