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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05605561
Other study ID # Pamukkale University HSI
Secondary ID 2022SABE007
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2022
Est. completion date September 15, 2023

Study information

Verified date December 2022
Source Pamukkale University
Contact Selver METE IZCI, Phd Candidate
Phone +90 0258 296 43 32
Email selvermete50@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date September 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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