Anxiety StateNCT04728555
Intervention of a Game About Radiotherapy for Children With Cancer
A study testing Game about radiotherapy in people with Anxiety State, run by Uppsala University at 1 site in Sweden.
Trial summary
Background: Radiotherapy (RT) can be stressful and challenging for children exposed to a highly technical environment with large radiation equipment and immobilization devices. A pedagogical digital game about RT has been developed. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Anxiety State
- What is being tested?
- Game about radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 31 Aug 2022
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-14 years old who are going to have radiotherapy at the Skandion Clinic, Uppsala with or without sedation/anesthesia, understand and can speak Swedish and have access to a computer.
Who cannot join
- Severe cognitive impairment and too seriously ill to be able to answer questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Intervention by a Pedagogical Digital Game About Radiotherapy for Children With Cancer
Background: Radiotherapy (RT) can be stressful and challenging for children exposed to a highly technical environment with large radiation equipment and immobilization devices. A pedagogical digital game about RT has been developed. Children who have received RT participated in work-shops and contributed with their experiences and suggestions.
Aim: To explore whether the intervention with a pedagogical digital game facilitate understanding, choice of distraction, creation of a sense of calmness and self-efficacy prior to and during RT and to describe the children's and the parents experiences and use of the game as a pedagogical tool. Further, to investigate feasibility in terms of reach, usability and acceptability.
Read more
Method: A feasibility and prospective waiting list control design is planned by recruiting 60 children (5-14 years) and their parents, for randomization into two groups. The first group will receive the game five days before start of RT. All children will have standard information one day before RT. The second group will have access to the game three days after start of treatment. The effects of the game will be investigated before and during RT and between groups as they receive the game at different time. Children will answer questionnaires about self-assessed anxiety, understanding of the procedure, distraction strategies, self-efficacy to remain motionless. Statistical comparative and correlational analyses will be calculated. Interviews will be performed with 12 children and 24 parents. Changes and further development of the game will be implemented based on the results of the responses.
Significance: The game can support children to undergo RT and be used nationally to prepare for RT. Thus all children receive similar information regardless of where they live, and contribute to increased knowledge, autonomy, reduce fear and anxiety. In the long term, the use of anesthesia could decrease for children.
Read the detailed description
Data Collection and procedure:
Access to the game for children randomized to the first group: Four to six days before start of treatment.
Questionnaires to all children: Questions about state and trait anxiety, and radiotherapy before the information meeting with the oncology nurse, one day before the start of treatment, at baseline.
Questionnaire to parents: Questions about state and trait anxiety before the information meeting with the oncology nurse at baseline.
Information meeting with all children and their parents: Information about radiotherapy by oncology nurse at baseline Questionnaires to all children: Questions about state anxiety and radiotherapy on treatment day one and three.
Access to the game for children randomized to the second group: Day three after start of treatment.
Questionnaire to all children: Questions about state anxiety on treatment day six and 15.
Questionnaire to all children: Questions about the digital game one week after access to the game.
Game logs: Collection of game logs one week after the intervention.
Interview of 12 children and 24 parents: Within four weeks after end of treatment.
Power: A power of 0.80, an alpha value of 0.05 and a size-effect of 0.5 provided an estimation of 26 participants in each group. Thirty participants are planned in case of dropouts.
Data analysis: Comparative and correlational statistical analyses.
- Conditions
- Anxiety State
- Being tested
- Game about radiotherapy
- Keywords
- Children, cancer, psychosocial support, serious game
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game about radiotherapyProcedure or surgery
A digital pedagogical game about radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Game before RT start | Experimental | Intervention of a digital game five days before start of RadioTherapy Receives: Procedure: Game about radiotherapy |
| Game after RT start | Experimental | Intervention of a digital game three days after start of RadioTherapy Receives: Procedure: Game about radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's State anxiety, change is being assessed
From the questionnaire STAI-C1
Measured: Baseline and on treatment day three, six and 15
Secondary outcomes (3)
Children's Trait anxiety
From the questionnaire STAI-C2
Measured: Baseline
Children's self-efficacy to remain motionless, change is being assessed
From a questionnaire made for the study
Measured: Baseline and on treatment day three
Children's perception of the digital game about radiotherapy: usability and engagement
From the questionnaire PENS
Measured: One week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Mar 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by Uppsala 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
- Model description
- A non-blinded randomized waiting list control study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Principal investigator, Gunn Engvall, Uppsala University
- Investigators
- Gunn Engvall, Professor, Principal investigator, Women's and Children's Health, Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728555
- Sponsor's protocol ID
- Children's RT Game 21-22
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be reported in scientific journals
Publications
Cederved C, Back J, Angstrom-Brannstrom C, Ljungman G, Engvall G. Co-creation of a Serious Game About Radiotherapy: Participatory Action Research Study With Children Treated for Cancer. JMIR Hum Factors. 2022 May 31;9(2):e34476. doi: 10.2196/34476.
PubMed 35639467Cederved C, Angstrom-Brannstrom C, Ljungman G, Engvall G. Parents' experiences of having their children take part in participatory action research creating a serious game about radiotherapy. Radiography (Lond). 2023 Jan;29(1):95-100. doi: 10.1016/j.radi.2022.10.005. Epub 2022 Oct 29.
PubMed 36327521Cederved C, Ljungman G, Angstrom-Brannstrom C, Engvall G. Children's experiences of coping with proton radiotherapy: A mixed-method study at a Swedish nationwide clinic. Radiography (Lond). 2026 Feb;32(2):103286. doi: 10.1016/j.radi.2025.103286. Epub 2025 Dec 18.
PubMed 41418736
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention by a Pedagogical Digital Game About Radiotherapy for Children With Cancer
- ClinicalTrials.gov ID
- NCT04728555
- Acronym / sponsor ID
- Children's RT Game 21-22
- Conditions
- Anxiety State
- Keywords
- Children, cancer, psychosocial support, serious game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Jan 2021 (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.
Background: Radiotherapy (RT) can be stressful and challenging for children exposed to a highly technical environment with large radiation equipment and immobilization devices. A pedagogical digital game about RT has been developed. Children who have received RT participated in work-shops and contributed with their experiences and suggestions.
Aim: To explore whether the intervention with a pedagogical digital game facilitate understanding, choice of distraction, creation of a sense of calmness and self-efficacy prior to and during RT and to describe the children's and the parents experiences and use of the game as a pedagogical tool. Further, to investigate feasibility in terms of reach, usability and acceptability.
Method: A feasibility and prospective waiting list control design is planned by recruiting 60 children (5-14 years) and their parents, for randomization into two groups. The first group will receive the game five days before start of RT. All children will have standard information one day before RT. The second group will have access to the game three days after start of treatment. The effects of the game will be investigated before and during RT and between groups as they receive the game at different time. Children will answer questionnaires about self-assessed anxiety, understanding of the procedure, distraction strategies, self-efficacy to remain motionless. Statistical comparative and correlational analyses will be calculated. Interviews will be performed with 12 children and 24 parents. Changes and further development of the game will be implemented based on the results of the responses.
Significance: The game can support children to undergo RT and be used nationally to prepare for RT. Thus all children receive similar information regardless of where they live, and contribute to increased knowledge, autonomy, reduce fear and anxiety. In the long term, the use of anesthesia could decrease for children.
Detailed description
Data Collection and procedure:
Access to the game for children randomized to the first group: Four to six days before start of treatment.
Questionnaires to all children: Questions about state and trait anxiety, and radiotherapy before the information meeting with the oncology nurse, one day before the start of treatment, at baseline.
Questionnaire to parents: Questions about state and trait anxiety before the information meeting with the oncology nurse at baseline.
Information meeting with all children and their parents: Information about radiotherapy by oncology nurse at baseline Questionnaires to all children: Questions about state anxiety and radiotherapy on treatment day one and three.
Access to the game for children randomized to the second group: Day three after start of treatment.
Questionnaire to all children: Questions about state anxiety on treatment day six and 15.
Questionnaire to all children: Questions about the digital game one week after access to the game.
Game logs: Collection of game logs one week after the intervention.
Interview of 12 children and 24 parents: Within four weeks after end of treatment.
Power: A power of 0.80, an alpha value of 0.05 and a size-effect of 0.5 provided an estimation of 26 participants in each group. Thirty participants are planned in case of dropouts.
Data analysis: Comparative and correlational statistical analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A non-blinded randomized waiting list control study
| Arm | Type | Receives |
|---|---|---|
| Game before RT start | Experimental | Procedure: Game about radiotherapyIntervention of a digital game five days before start of RadioTherapy |
| Game after RT start | Experimental | Procedure: Game about radiotherapyIntervention of a digital game three days after start of RadioTherapy |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 5-14 years old who are going to have radiotherapy at the Skandion Clinic, Uppsala with or without sedation/anesthesia, understand and can speak Swedish and have access to a computer.
Key exclusion criteria (1 listed)
- Severe cognitive impairment and too seriously ill to be able to answer questions.
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 |
|---|---|---|
| Game about radiotherapyA digital pedagogical game about radiotherapy | Procedure or surgery | Game after RT start, Game before RT start |
Primary outcome
Children's State anxiety, change is being assessed
Time frame: Baseline and on treatment day three, six and 15
From the questionnaire STAI-C1
3 secondary outcomes
Children's Trait anxiety
Time frame: Baseline
Children's self-efficacy to remain motionless, change is being assessed
Time frame: Baseline and on treatment day three
Children's perception of the digital game about radiotherapy: usability and engagement
Time frame: One week after the intervention
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 9 Mar 2023.
- Background: PubMed 35639467Cederved C, Back J, Angstrom-Brannstrom C, Ljungman G, Engvall G. Co-creation of a Serious Game About Radiotherapy: Participatory Action Research Study With Children Treated for Cancer. JMIR Hum Factors. 2022 May 31;9(2):e34476. doi: 10.2196/34476.
- Background: PubMed 36327521Cederved C, Angstrom-Brannstrom C, Ljungman G, Engvall G. Parents' experiences of having their children take part in participatory action research creating a serious game about radiotherapy. Radiography (Lond). 2023 Jan;29(1):95-100. doi: 10.1016/j.radi.2022.10.005. Epub 2022 Oct 29.
- Derived from this study: PubMed 41418736Cederved C, Ljungman G, Angstrom-Brannstrom C, Engvall G. Children's experiences of coping with proton radiotherapy: A mixed-method study at a Swedish nationwide clinic. Radiography (Lond). 2026 Feb;32(2):103286. doi: 10.1016/j.radi.2025.103286. Epub 2025 Dec 18.
- Individual participant dataSharing planned: No. Results will be reported in scientific journals
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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.
Gunn Engvall, Professor principal investigator
Women's and Children's Health, Uppsala University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game about radiotherapy in people with Anxiety State, run by Uppsala University at 1 site in Sweden.
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 9 Mar 2023. 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 Sweden. 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 State anxiety, change is being assessed (time frame: Baseline and on treatment day three, six and 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728555, which also lists 3 linked publications.
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 9 Mar 2023.