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

NCT ID: NCT06583668

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Burns Fear Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: Therapeutic Story group

I. Assessment:Before the burn dressing II. Assessment: During burn dressing II. Assessment: After burn dressing

Group Type EXPERIMENTAL

Therapeutic Story

Intervention Type OTHER

Listening and watching the therapeutic story in digital media

Standard care

I. Assessment:Before the burn dressing II. Assessment: During burn dressing II. Assessment: After burn dressing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Therapeutic Story

Listening and watching the therapeutic story in digital media

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Okan University

OTHER

Sponsor Role lead

Responsible Party

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Niran Coban

Asst.Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niran ÇOBAN, Dr

Role: STUDY_DIRECTOR

Okan University

Niran ÇOBAN, Dr

Role: STUDY_DIRECTOR

https://www.okan.edu.tr/

Locations

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Istanbul- City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22588748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36859758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27129580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24823326 (View on PubMed)

Other Identifiers

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NSS0

Identifier Type: -

Identifier Source: org_study_id

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