Children With CancerNCT06524050
Puppet Show and Storytelling Effect Among Children With Cancer
A study of Children With Cancer, run by Abeer Abd Elwahed Almowafy at 1 site in Egypt.
Trial summary
Objective The objective of this study was to evaluate the effectiveness of puppet show and storytelling effect on oral medication adherence and negative emotions among children with cancer. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Children With Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 13 Dec 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 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with cancer who were diagnosed with the disease
- stay in the hospital for a minimum of three days in a row.
- The children were aged between three and twelve.
Who cannot join
- Children who were getting palliative care
- weren't enrolled in a comparable program
- those with recognized cognitive
- learning disabilities were not included in our sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Puppet Show and Storytelling Effect on Oral Medication Adherence and Negative Emotions Among Children With Cancer
Objective The objective of this study was to evaluate the effectiveness of puppet show and storytelling effect on oral medication adherence and negative emotions among children with cancer.
Methods A non-equivalent control group pre-test and post-test, between subjects design was conducted in the Maternity \& Children Hospital Bisha, Al-Namas General Hospital, Kingdom of Saudi Arabia and Suez Canal University Hospital at Egypt. A total of 100 children (ages 3-12) admitted for treatments in this hospital were invited to participate in the study. Of the 100 paediatric patients; 50 received puppet show and storytelling interventions and 50 received usual care.
Read the detailed description
Hospitalization is a stressful and threatening experience, which can be emotionally devastating to children with cancer. Pediatric nurses play interventions such as puppet show and storytelling have been used to promote oral medication adherence for children with cancer also to help them to overcome their negative emotions during hospitalization
.
- Conditions
- Children With Cancer
- Being tested
- standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard careBehavioural
standard care
| Study group | Role | What they receive |
|---|---|---|
| Puppet Show and Storytelling Effect among Children with Cancer | Experimental | puppet show and storytelling interventions Receives: Behavioral: standard care |
| standard care | No intervention | standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurment tool: Questionnaire Evaluate the effectiveness of puppet shows and storytelling effect on oral medication adherence and negative emotions among children with cancer
Puppet Show and Storytelling Effect on Oral Medication Adherence and Negative Emotions among Children with Cancer
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jun 2023
- Primary completion25 Aug 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abeer Abd Elwahed Almowafy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abeer Abd Elwahed Almowafy, Al-Azhar University
- Investigators
- Abeer Almowafy, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524050
- Sponsor's protocol ID
- UB-RELOC H-06-BH-087)/ 1205.24
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puppet Show and Storytelling Effect on Oral Medication Adherence and Negative Emotions Among Children With Cancer
- ClinicalTrials.gov ID
- NCT06524050
- Acronym / sponsor ID
- UB-RELOC H-06-BH-087)/ 1205.24
- Conditions
- Children With Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abeer Abd Elwahed AlmowafyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 29 Jul 2024 (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.
Objective The objective of this study was to evaluate the effectiveness of puppet show and storytelling effect on oral medication adherence and negative emotions among children with cancer.
Methods A non-equivalent control group pre-test and post-test, between subjects design was conducted in the Maternity \& Children Hospital Bisha, Al-Namas General Hospital, Kingdom of Saudi Arabia and Suez Canal University Hospital at Egypt. A total of 100 children (ages 3-12) admitted for treatments in this hospital were invited to participate in the study. Of the 100 paediatric patients; 50 received puppet show and storytelling interventions and 50 received usual care.
Detailed description
Hospitalization is a stressful and threatening experience, which can be emotionally devastating to children with cancer. Pediatric nurses play interventions such as puppet show and storytelling have been used to promote oral medication adherence for children with cancer also to help them to overcome their negative emotions during hospitalization
.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puppet Show and Storytelling Effect among Children with Cancer | Experimental | Behavioral: standard carepuppet show and storytelling interventions |
| standard care | No intervention | –standard care |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with cancer who were diagnosed with the disease
- stay in the hospital for a minimum of three days in a row.
- The children were aged between three and twelve.
Key exclusion criteria (4 listed)
- Children who were getting palliative care
- weren't enrolled in a comparable program
- those with recognized cognitive
- learning disabilities were not included in our sample
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 |
|---|---|---|
| standard carestandard care | Behavioural | Puppet Show and Storytelling Effect among Children with Cancer |
Primary outcome
Measurment tool: Questionnaire Evaluate the effectiveness of puppet shows and storytelling effect on oral medication adherence and negative emotions among children with cancer
Time frame: 12 weeks
Puppet Show and Storytelling Effect on Oral Medication Adherence and Negative Emotions among Children with Cancer
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 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Children With Cancer
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
RecruitingPhase 1/2
Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
Recurrent Ganglioneuroblastoma, Recurrent Neuroblastoma
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 3
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
RecruitingObservational study
Children and Adults With Chordoma
Chordoma
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.
Abeer Almowafy principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Children With Cancer, run by Abeer Abd Elwahed Almowafy at 1 site in Egypt.
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 3 inclusion and 4 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 29 Jul 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 Egypt. 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?
Measurment tool: Questionnaire Evaluate the effectiveness of puppet shows and storytelling effect on oral medication adherence and negative emotions among children with cancer (time frame: 12 weeks). 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 29 Jul 2024.