ChildNCT05605561
The Effect of Digital Storytelling Applied to Children in Preoperative Period
A study testing Digital Story in people with Child and Preoperative Period, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Child, Preoperative Period
- What is being tested?
- Digital Story
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to hospital for day surgery Having internet Access Written informed consent from family and volunteers to participate in the study
Who cannot join
- Children with neurological development and learning problems Children with chronic illness who require special medical care No internet Access
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20100
About this study
Official title: The Effect of Digital Storytelling Applied to Children in the Preoperative Period on Anxiety and Negative Emotional Behaviours
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.
Read the detailed 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.
- Conditions
- Child, Preoperative Period
- Being tested
- Digital Story
- Keywords
- children, preoperative period, digital storytelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital StoryOther
Also called Standard Maintenance Group
It is the standard of care given according to the hospital's policies and procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Digital Story |
| Standard Maintenance Group | No intervention | It is the standard of care given according to the hospital's policies and procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Preoperative Clinic: 5-7 days before Day Surgery, Day Surgery Day: In the Surgery Waiting Room,At home: 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start15 Nov 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selver METE İZCİ, Pamukkale University
- Investigators
- Bengü ÇETİNKAYA, Phd,Prof., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605561
- Sponsor's protocol ID
- Pamukkale University HSI
- Other IDs
- 2022SABE007
- Status last verified
- Jun 2024
- First submitted
- 31 Oct 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Storytelling Applied to Children in the Preoperative Period on Anxiety and Negative Emotional Behaviours
- ClinicalTrials.gov ID
- NCT05605561
- Acronym / sponsor ID
- Pamukkale University HSI
- Conditions
- Child, Preoperative Period
- Keywords
- children, preoperative period, digital storytelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Digital Story) | Experimental | Other: Digital StoryThe 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). |
| Standard Maintenance Group | No intervention | –It is the standard of care given according to the hospital's policies and procedures. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Admission to hospital for day surgery Having internet Access Written informed consent from family and volunteers to participate in the study
Key exclusion criteria (1 listed)
- Children with neurological development and learning problems Children with chronic illness who require special medical care No internet Access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital StoryAlso: Standard Maintenance GroupIt is the standard of care given according to the hospital's policies and procedures. | Other | Intervention Group (Digital Story) |
Primary outcome
Children's Emotional Manifestation Scale
Time frame: Day Surgery Day: In the Surgery Waiting Room
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.
Physiological Measurement Form
Time frame: Day Surgery Day: In the Surgery Waiting Room
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).
State Anxiety Scale for Children (How Do I Feel Questionnaire)
Time frame: Preoperative Clinic: 5-7 days before Day Surgery, Day Surgery Day: In the Surgery Waiting Room,At home: 2 weeks postoperatively
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No. no.
Related trials for Child
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengü ÇETİNKAYA, Phd,Prof. study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Story in people with Child and Preoperative Period, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Emotional Manifestation Scale (time frame: Day Surgery Day: In the Surgery Waiting Room). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.