The Effect of Digital Storytelling Applied to Children in Preoperative Period

NCT ID: NCT05605561

Last Updated: 2024-06-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The type of study planned is randomized controlled experimental design. The study group is divided into two as intervention and control groups. The intervention and control groups will be selected by simple random sampling method from among the volunteer participants who meet the inclusion criteria. Power analysis was performed to determine the sample size. It was observed that the effect size obtained in the reference study (Chow et al. 2017) was quite strong (d=0.96). As a result of the power analysis we performed, assuming that a lower level of effect size could be obtained (d=0.8), it was calculated that 80% power could be obtained at the 95% confidence level when at least 52 people (at least 26 people for each group) were included in the study. Considering that there may be data losses, the sample size was planned as 72 people (36 people for each group), taking approximately 30% more than the number of samples calculated as a result of the power analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Preoperative Period

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group (Digital Story)

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).

Group Type EXPERIMENTAL

Digital Story

Intervention Type OTHER

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

Standard Maintenance Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Story

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Standard Maintenance Group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Selver METE İZCİ

Phd Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bengü ÇETİNKAYA, Phd,Prof.

Role: STUDY_DIRECTOR

Pamukkale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamukkale University

Denizli, Pamukkale, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022SABE007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pamukkale University HSI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Child in Hospital and Playing
NCT06052761 COMPLETED NA