NCT05605561

Brief Summary

Digital storytelling is the craft and art of exploring different media and software applications to communicate stories in new and powerful ways using digital media. Because new digital tools are inexpensive and widely available, digital storytelling tends to be highly personal and at the same time universal. All in all, it is a very powerful form of communication. Digital storytelling applications include short (three to five minute) films with pictures, video clips, soundtrack and narration; storytelling performances and talks supported by media slideshows or interactive presentations; and web-based applications, including streaming media, podcasts, and blogs. When looking at the literature, different approaches to using digital storytelling are seen: it is used in the education of health professionals, in academic education, for digital story development and research, and as a therapeutic care intervention. Studies on the use of digital stories in the field of health have just begun to gain popularity, and it is noteworthy that the studies in the health services literature are not yet at the desired level and prevalence. Healthcare is a unique environment to use digital storytelling intervention as a therapeutic purpose in addition to gaining knowledge in all our activities. Using digital stories; It is thought that it will provide significant benefits to parents/children and health professionals by filling the gap in the literature in order to reduce the negative emotional behaviors and anxiety of children undergoing day surgery in the preoperative period, as an informative intervention that can attract the attention of their children while having fun.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

October 31, 2022

Last Update Submit

June 22, 2024

Conditions

Keywords

childrenpreoperative perioddigital storytelling

Outcome Measures

Primary Outcomes (3)

  • Children's Emotional Manifestation Scale

    This scale was developed by Li and Lopez (2005) to measure the emotional responses of children during stressful medical procedures. Children's Emotional Manifestation Scale was adapted into Turkish by Mete Izci and Çetinkaya (2020). Turkish version of the Children's Emotional Manifestation scale (T-CEMS) was found to be valid and reliable in order to measure the emotional responses of children before stressful medical procedures or in the preoperative period.

    Day Surgery Day: In the Surgery Waiting Room

  • Physiological Measurement Form

    This form consists of children's physiological measurements (pulse, blood pressure and respiration). Physiological measurements will be based on pulse (60-95 beats/minute), blood pressure (100-120/60-75 mmHg) and respiration (14-22 minutes) values, which are considered normal for the 6-12 age group (Hartman and Cheifetz). 2011).

    Day Surgery Day: In the Surgery Waiting Room

  • State Anxiety Scale for Children (How Do I Feel Questionnaire)

    The Children's State Trait Anxiety Inventory was developed by Spielberger in 1973 for 4th and 6th grade children, and its Turkish validity and reliability was established by Özusta (1995) in 615 children aged 9-12 (Özusta 1995).

    Preoperative Clinic: 5-7 days before Day Surgery, Day Surgery Day: In the Surgery Waiting Room,At home: 2 weeks postoperatively

Study Arms (2)

Intervention Group (Digital Story)

EXPERIMENTAL

The web-based digital story preparation process will be completed as a 3-5 minute short film by using pictures, videos, voiceovers and various video editing techniques by the researcher trained in storytelling. The digital story will be prepared in an appropriate format, taking into account the cognitive development and period characteristics of school children (7-12 years old).

Other: Digital Story

Standard Maintenance Group

NO INTERVENTION

It is the standard of care given according to the hospital's policies and procedures.

Interventions

It is the standard of care given according to the hospital's policies and procedures.

Also known as: Standard Maintenance Group
Intervention Group (Digital Story)

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Admission to hospital for day surgery Having internet Access Written informed consent from family and volunteers to participate in the study

You may not qualify if:

  • Children with neurological development and learning problems Children with chronic illness who require special medical care No internet Access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20100, Turkey (Türkiye)

Location

Study Officials

  • Bengü ÇETİNKAYA, Phd,Prof.

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this study, study and control groups were determined using the simple randomization method to prevent selection bias. Patients do not know that they are in the experimental and control groups. The data in the study was collected by the researcher. To prevent bias during data collection, the State Anxiety Scale, which could enable patients to self-report, was used. The research was conducted according to the CONSORT 2010 reporting guideline (Schulz et al., 2010). In order to prevent reporting bias, the research data were evaluated by a statistician.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Candidate

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 4, 2022

Study Start

November 15, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

no.

Locations