Targeted Temperature ManagementNCT07239206
Serious Game for Improving Targeted Temperature Management Knowledge and Situational Awareness in Critical Care Nurses
A study testing Serious Game Intervention and Lecture-based Education in people with Targeted Temperature Management and Nursing Education, run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of a serious game in improving targeted temperature management (TTM) knowledge and situational awareness among critical care nurses. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Targeted Temperature Management, Nursing Education, Serious Game
- What is being tested?
- Serious Game Intervention and Lecture-based Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered nurses currently working in adult intensive care units (medical, surgical, or mixed ICUs).
- Able to read and understand Chinese.
- Willing to participate and provide informed consent.
- Available to complete pre-test, post-test, and follow-up assessments.
Who cannot join
- Nurses working in pediatric or neonatal ICUs.
- Nurses holding administrative or supervisory positions (non-clinical).
- Nurses currently participating in other TTM-related educational or research programs.
- Individuals unable to complete the intervention or evaluation schedule.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Hui Yi Li, RN, 886-920-868-591, bicky05@ntuh.gov.tw
About this study
Official title: Effectiveness of Serious Game on Facilitating Targeted Temperature Management Knowledge and Situational Awareness Among Critical Care Nurses
This randomized controlled trial aims to evaluate the effectiveness of a serious game in improving targeted temperature management (TTM) knowledge and situational awareness among critical care nurses. A total of 120 nurses from adult intensive care units will be randomly assigned to either a control group receiving traditional lecture-based teaching or an experimental group receiving lecture-based teaching combined with a digital serious game. Outcomes will be measured using a TTM knowledge test, a situational awareness scale, and a system usability scale. The findings will provide evidence for the use of serious games as an innovative educational strategy to enhance post-resuscitation care quality and patient safety.
Read the detailed description
Targeted temperature management (TTM) is an evidence-based neuroprotective strategy recommended for patients resuscitated after cardiac arrest. Despite its clinical importance, critical care nurses often lack sufficient knowledge and situational awareness to effectively implement TTM, due to limited exposure to relevant cases and time constraints in training. Conventional teaching methods, while beneficial, face challenges such as limited resources, time, and opportunities for repeated practice.
Serious games, which integrate educational content with interactive digital game elements, offer a flexible and engaging learning tool that enables repeated practice in a safe, simulated environment. Previous studies have shown that serious games can enhance learners' motivation, knowledge retention, and decision-making skills.
This study will develop and implement a serious game specifically designed for TTM education. The randomized controlled trial will enroll 120 intensive care unit nurses, randomly allocated into two groups: the control group will receive lecture-based teaching with case discussion, while the experimental group will receive the same content supplemented with the serious game for additional practice. All participants will complete a pre-test, a post-test one week after the intervention, and a follow-up test at six weeks.
The primary outcome will be the improvement in TTM knowledge, and secondary outcomes will include situational awareness and system usability (experimental group only). The study is expected to provide evidence that serious games are an effective and scalable strategy for enhancing TTM-related knowledge and situational awareness, thereby supporting better quality of post-resuscitation care and patient safety.
- Being tested
- Serious Game Intervention, Lecture-based Education
- Keywords
- Targeted temperature management, Serious game
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious Game InterventionBehavioural
A digital serious game designed to train critical care nurses in targeted temperature management (TTM). The game features case-based simulations, interactive decision-making, and real-time feedback to improve clinical reasoning and situational awareness.
Lecture-based EducationBehavioural
Standard lecture-based teaching covering the principles, procedures, and nursing care of targeted temperature management (TTM). Participants in this group do not receive the serious game component.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Serious Game + Lecture | Experimental | Participants in this arm will receive lecture-based teaching combined with a digital serious game designed to enhance targeted temperature management (TTM) knowledge and situational awareness. The serious game includes interactive case scenarios, decision-making tasks, and real-time feedback to simulate ICU situations and reinforce learning. Receives: Behavioral: Serious Game Intervention; Behavioral: Lecture-based Education |
| Active Comparator: Lecture Only | Active comparator | Participants in this arm will receive lecture-based teaching with case discussion only, covering the same targeted temperature management (TTM) content as the experimental group. No serious game intervention will be provided. Receives: Behavioral: Lecture-based Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Targeted Temperature Management (TTM) Knowledge Score
TTM knowledge will be assessed using a validated 16-item multiple-choice questionnaire developed based on current clinical guidelines. Scores range from 0 to 100, with higher scores indicating greater knowledge of targeted temperature management principles and nursing care.
Measured: Baseline (pre-test), 1 week after intervention, and 6 weeks after intervention
Change in Situational Awareness (SA) Score
Situational awareness will be measured using a 11-item Likert scale (1-5) questionnaire assessing perception, comprehension, and projection dimensions. Total scores range from 12 to 60, with higher scores indicating greater situational awareness in clinical TTM scenarios.
Measured: Baseline, 1 week after intervention, and 6 weeks after intervention
System Usability Scale (SUS) Score
The usability of the serious game will be evaluated using the 10-item System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating better system usability and learner satisfaction.
Measured: 1 week after intervention (experimental group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start19 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Targeted Temperature ManagementStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into two parallel groups. The experimental group will receive lecture-based teaching combined with a digital serious game intervention, while the control group will receive lecture-based teaching with case discussion only. Randomization will be performed at the beginning of each class session to ensure balanced group allocation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Clinical Trial Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239206
- Sponsor's protocol ID
- 202507084RINA
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.
PubMed 12847056Gorbanev I, Agudelo-Londono S, Gonzalez RA, Cortes A, Pomares A, Delgadillo V, Yepes FJ, Munoz O. A systematic review of serious games in medical education: quality of evidence and pedagogical strategy. Med Educ Online. 2018 Dec;23(1):1438718. doi: 10.1080/10872981.2018.1438718.
PubMed 29457760Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25.
PubMed 33765189
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Serious Game on Facilitating Targeted Temperature Management Knowledge and Situational Awareness Among Critical Care Nurses
- ClinicalTrials.gov ID
- NCT07239206
- Acronym / sponsor ID
- 202507084RINA
- Keywords
- Targeted temperature management, Serious game
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University Clinical Trial CenterUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2025 (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.
This randomized controlled trial aims to evaluate the effectiveness of a serious game in improving targeted temperature management (TTM) knowledge and situational awareness among critical care nurses. A total of 120 nurses from adult intensive care units will be randomly assigned to either a control group receiving traditional lecture-based teaching or an experimental group receiving lecture-based teaching combined with a digital serious game. Outcomes will be measured using a TTM knowledge test, a situational awareness scale, and a system usability scale. The findings will provide evidence for the use of serious games as an innovative educational strategy to enhance post-resuscitation care quality and patient safety.
Detailed description
Targeted temperature management (TTM) is an evidence-based neuroprotective strategy recommended for patients resuscitated after cardiac arrest. Despite its clinical importance, critical care nurses often lack sufficient knowledge and situational awareness to effectively implement TTM, due to limited exposure to relevant cases and time constraints in training. Conventional teaching methods, while beneficial, face challenges such as limited resources, time, and opportunities for repeated practice.
Serious games, which integrate educational content with interactive digital game elements, offer a flexible and engaging learning tool that enables repeated practice in a safe, simulated environment. Previous studies have shown that serious games can enhance learners' motivation, knowledge retention, and decision-making skills.
This study will develop and implement a serious game specifically designed for TTM education. The randomized controlled trial will enroll 120 intensive care unit nurses, randomly allocated into two groups: the control group will receive lecture-based teaching with case discussion, while the experimental group will receive the same content supplemented with the serious game for additional practice. All participants will complete a pre-test, a post-test one week after the intervention, and a follow-up test at six weeks.
The primary outcome will be the improvement in TTM knowledge, and secondary outcomes will include situational awareness and system usability (experimental group only). The study is expected to provide evidence that serious games are an effective and scalable strategy for enhancing TTM-related knowledge and situational awareness, thereby supporting better quality of post-resuscitation care and patient safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups. The experimental group will receive lecture-based teaching combined with a digital serious game intervention, while the control group will receive lecture-based teaching with case discussion only. Randomization will be performed at the beginning of each class session to ensure balanced group allocation.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Serious Game + Lecture | Experimental | Behavioral: Serious Game Intervention, Behavioral: Lecture-based EducationParticipants in this arm will receive lecture-based teaching combined with a digital serious game designed to enhance targeted temperature management (TTM) knowledge and situational awareness. The serious game includes interactive case scenarios, decision-making tasks, and real-time feedback to simulate ICU situations and reinforce learning. |
| Active Comparator: Lecture Only | Active comparator | Behavioral: Lecture-based EducationParticipants in this arm will receive lecture-based teaching with case discussion only, covering the same targeted temperature management (TTM) content as the experimental group. No serious game intervention will be provided. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Registered nurses currently working in adult intensive care units (medical, surgical, or mixed ICUs).
- Able to read and understand Chinese.
- Willing to participate and provide informed consent.
- Available to complete pre-test, post-test, and follow-up assessments.
Key exclusion criteria (4 listed)
- Nurses working in pediatric or neonatal ICUs.
- Nurses holding administrative or supervisory positions (non-clinical).
- Nurses currently participating in other TTM-related educational or research programs.
- Individuals unable to complete the intervention or evaluation schedule.
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 |
|---|---|---|
| Serious Game InterventionA digital serious game designed to train critical care nurses in targeted temperature management (TTM). The game features case-based simulations, interactive decision-making, and real-time feedback to improve clinical reasoning and situational awareness. | Behavioural | Experimental: Serious Game + Lecture |
| Lecture-based EducationStandard lecture-based teaching covering the principles, procedures, and nursing care of targeted temperature management (TTM). Participants in this group do not receive the serious game component. | Behavioural | Active Comparator: Lecture Only, Experimental: Serious Game + Lecture |
Primary outcome
Change in Targeted Temperature Management (TTM) Knowledge Score
Time frame: Baseline (pre-test), 1 week after intervention, and 6 weeks after intervention
TTM knowledge will be assessed using a validated 16-item multiple-choice questionnaire developed based on current clinical guidelines. Scores range from 0 to 100, with higher scores indicating greater knowledge of targeted temperature management principles and nursing care.
Change in Situational Awareness (SA) Score
Time frame: Baseline, 1 week after intervention, and 6 weeks after intervention
Situational awareness will be measured using a 11-item Likert scale (1-5) questionnaire assessing perception, comprehension, and projection dimensions. Total scores range from 12 to 60, with higher scores indicating greater situational awareness in clinical TTM scenarios.
System Usability Scale (SUS) Score
Time frame: 1 week after intervention (experimental group only)
The usability of the serious game will be evaluated using the 10-item System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating better system usability and learner satisfaction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 12847056Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.
- Background: PubMed 29457760Gorbanev I, Agudelo-Londono S, Gonzalez RA, Cortes A, Pomares A, Delgadillo V, Yepes FJ, Munoz O. A systematic review of serious games in medical education: quality of evidence and pedagogical strategy. Med Educ Online. 2018 Dec;23(1):1438718. doi: 10.1080/10872981.2018.1438718.
- Background: PubMed 33765189Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious Game Intervention and Lecture-based Education in people with Targeted Temperature Management and Nursing Education, run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
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 4 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUI-YI LI (0920867591, bicky05@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Targeted Temperature Management (TTM) Knowledge Score (time frame: Baseline (pre-test), 1 week after intervention, and 6 weeks after intervention). 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?
On the ClinicalTrials.gov record for NCT07239206, 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 22 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.