EducationNCT06859632
45 Minutes Vs. Three Hours Educational Intervention on Communication and Play for Paediatric Healthcare Professionals
A study testing 3-hour educational intervention and 45-minute educational intervention in people with Education and Communication, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The goal for this trial is to test the effect of an educational programme on communication and play for healthcare professionals working with children and adolescents. The main questions to answer are: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Communication, Play
- What is being tested?
- 3-hour educational intervention and 45-minute educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Mar 2025to 30 Oct 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthcare professionals employed in the Department of Paediatrics and Adolescent Medicine at Rigshospitalet (nurses, doctors, physiotherapist, occupational therapists, dieticians, medical secretaries, and social workers)
- Provide signed informed consent before randomisation
Who cannot join
- Staff taking part in planning of the intervention
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Healthcare Professionals' Self-efficacy of a 45-minute vs Three-hour Educational Intervention on Communication and Play in Paediatric Clinical Practice: A Randomised Controlled Trial Study Protocol
The goal for this trial is to test the effect of an educational programme on communication and play for healthcare professionals working with children and adolescents. The main questions to answer are:
- Does a 45-minute educational intervention on communication and play have the same effect on healthcare professionals' self-efficacy in patient-centredness compared with a three-hour intervention?
- What is the effect of the intervention on participants' motivation to engage in the educational activity, cognitive load, knowledge, satisfaction, and the impact on their individual practice ?
Participants will be randomly assigned to either a 45-minute or a three-hour educational intervention. They will complete a questionnaire at three time points: before the intervention, immediately after, and at a 12-week follow-up.
Read the detailed description
BACKGROUND: Communication is an essential skill for all healthcare professionals working with children and adolescents in hospitals. There is growing focus on child-centred communication, which emphasize communicating directly with children and adolescents in healthcare rather than focusing on the parents. However, educational programmes for this remain limited while those that exist are heterogenous and often assessed without comparison groups or validated tools.
OBJECTIVE: To investigate the effect on healthcare professionals' self-efficacy of a 45-minute vs three-hour educational intervention on communication and the use of play in clinical paediatric practice
INTERVENTION: This trial evaluates the educational programme "Communication and Play with Children and Adolescents in Healthcare", which focuses on age-appropriate communication with paediatric patients, including the deliberate use of play. The trial compares two educational interventions that differ in duration (45 minutes vs. three hours) and learning methods. While both interventions include didactic learning, reflection, and discussions, the three-hour session adds role-play activities, whereas the 45-minute session delivers a condensed version without role-play.
DESIGN: Single-centre, randomized, controlled, two-arm, noninferiority trial. A noninferiority design is used to assess whether there is a difference between the two educational interventions or if the 45-minute educational intervention is comparable to the three-hour educational intervention.
SETTING: The University Hospital of Copenhagen - Rigshospitalet, Denmark.
RECRUITMENT: All healthcare professionals working in the Department of Paediatrics and Adolescent Medicine at Rigshospitalet will be eligible to participate. Potential participants will be contacted by their leaders and be informed of the study. A written consent will then be obtained.
SAMPLE SIZE: The sample size calculation assumes that the 45-minute intervention is as effective as the three-hour intervention for the primary outcome (self-efficacy). A non-inferiority margin of 0.25 points is set, meaning the mean self-efficacy score for the 45-minute intervention can be up to 0.25 points lower than that of the three-hour intervention without being considered inferior. Based on a one-sided two-sample t-test with a margin of 0.25, an alpha of 0.025, a power of 80%, and a standard deviation of 0.45 derived from the pilot study, the required sample size is 52 participants per group. Since the intervention is conducted in clusters of 25 participants, the sample size calculation is adjusted for cluster randomization by multiplying by the design effect, calculated as 1 + (cluster size - 1) × ICC. Assuming an ICC of 0.01 results in a design effect of 1.24 and an adjusted sample size of 65 per group. Accounting for a 10% dropout rate, the final required sample size is 72 per group. It is planned to include a total of 150 participants.
RANDOMIZATION: Eligible participants will be randomly assigned in a 1:1 ratio to either a 45-minute educational intervention or a three-hour educational intervention using computer-generated block randomization through REDCap. The randomization process will ensure an interprofessional distribution of participants in each intervention group. Both the statistician and the researchers conducting the analysis will be blinded to participant allocation.
ETHICS: This trial complies with the principles outlined in the Declaration of Helsinki for biomedical research. Approval has been obtained from the Danish Data Protection Agency (P-2021-426). The study was approved but deemed exempt from requiring ethical approval by The Scientific Ethical Committees for the Capital Region of Denmark (Journal-nr.: H-21028050). Participation is entirely voluntary, and both educational interventions will take place during working hours at no cost to the participants. Participants may withdraw from the study at any time without any repercussions. To ensure confidentiality, all data will be securely stored in a protected database.
- Conditions
- Education, Communication, Play, Pediatrics
- Being tested
- 3-hour educational intervention, 45-minute educational intervention
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-hour educational interventionOther
A 3-hour educational intervention on communication and the use of play in paediatric clinical practice.
Participants in both arms will have access to written learning material and an app that has been developed.
45-minute educational interventionOther
A 45-minute educational intervention on communication and the use of play in paediatric clinical practice.
Participants in both arms will have access to written learning material and an app that has been developed.
| Study group | Role | What they receive |
|---|---|---|
| 45-minute educational intervention | Active comparator | Participants will receive a 45-minute educational intervention on communication and the use of play in paediatric clinical practice Receives: Other: 45-minute educational intervention |
| 3-hour educational intervention | Experimental | Participants will receive a 3-hour educational intervention on communication and the use of play in paediatric clinical practice Receives: Other: 3-hour educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
Self-efficacy measured using a 10-item questionnaire on a 5-point likert scale (1 = very low degree, 5 = very high degree). Questions are adapted from the Danish version of the validated Self-Efficacy in Patient-Centeredness Questionnaire (SEPCQ-27).This questionnaire evaluates participants' confidence in their ability to build relationships and communicate with children and adolescents in hospital settings.
Measured: From enrollment to 12-week follow-up
Secondary outcomes (5)
Motivation
Motivation measured by using the validated Intrinsic Motivation Inventory (IMI). The IMI is a self-report questionnaire that measures a person's subjective experience related to a specific activity on a Likert scale ranging from 1 (Not at all true) to 7 (Very true). The standard IMI includes 22 items. For this study, the 7-item Interest/Enjoyment subscale is used, which is considered to directly measure intrinsic motivation related to a recently completed activity.
Measured: Immediately after intervention
Self-evaluated knowledge about paediatric communication
The participants self-perceived knowledge about paediatric communication will be assessed using a single item. The question is "What is your knowledge about age-appropriate communication with children and adolescents?" (5 point Likert scale from "no knowledge" to "very high knowledge").
Measured: From enrollment to 12 week follow-up
Cognitive load
Measured using the Mental effort rating scale by Paas (1992). This validated, single item measure asks participants to rate their perceived mental effort ranging from "very, very low mental effort" to "very, very high mental effort" on a 9-point Likert scale.
Measured: Immediately after intervention
Satisfaction with intervention
Participant satisfaction will be measured using a pre-designed questionnaire to assess participants' perceptions and satisfaction with the interventions. It will include five items covering relevance to clinical practice, overall quality, and whether they would recommend it to other healthcare professionals. One open-ended questions will invite participants to share general feedback and any additional comments about their experience.
Measured: Immediately after intervention
Impact on individual practice and training need
Impact on individual practice and training needs will be evaluated through five items that examine whether participants changed their own practice, engaged with further reading, or identified a need for more training. Possible scores range from 1 (not at all) to 5 (to a very high degree).
Measured: 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start5 Mar 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Thestrup Hansen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859632
- Sponsor's protocol ID
- P-2021-426
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data to replicate the analysis will be available from the corresponding author (ORCID: 0000-0002-0093-8555) on reasonable request until five years after completion of the study, according to Danish law.
Publications
Krebs CL, Thestrup J, Hybschmann J, Graber K, Gjaerde LK, Topperzer MK, Nielsen ET, Larsen A, Ramchandani P, Frandsen TL, Sorensen JL. A BEME review of educational programmes on the use of play in paediatric practice: BEME Guide No. 82. Med Teach. 2024 Nov;46(11):1393-1403. doi: 10.1080/0142159X.2023.2287983. Epub 2023 Dec 14.
PubMed 38098168Thestrup J, Sorensen JL, Esbjorn BH, Hybschmann J, Frandsen TL, DeCosta P, Gjaerde LK. Paediatric patient perceptions of healthcare professionals: contributions to a communication curriculum. Eur J Pediatr. 2024 Dec 12;184(1):75. doi: 10.1007/s00431-024-05911-x.
PubMed 39663230Jeppesen E, Schmidt AA, Skjodt CK, Hybschmann J, Gjaerde LK, Thestrup J, Hansson H, Sorensen JL. Educational programmes for paediatric healthcare professionals in patient- and family-centred care. A scoping review. Eur J Pediatr. 2024 May;183(5):2015-2028. doi: 10.1007/s00431-024-05455-0. Epub 2024 Mar 2.
PubMed 38430279Thestrup J, Sorensen JL, Hybschmann J, Topperzer MK, Graber K, O'Farrelly C, Gibson J, Ramchandani P, Frandsen TL, Gjaerde LK. Establishing consensus on principles and competencies for the use of play in clinical practice in hospitals: An international Delphi study. Eur J Pediatr. 2024 Apr;183(4):1595-1605. doi: 10.1007/s00431-023-05411-4. Epub 2024 Jan 6.
PubMed 38183437Gjaerde LK, Hybschmann J, Dybdal D, Topperzer MK, Schroder MA, Gibson JL, Ramchandani P, Ginsberg EI, Ottesen B, Frandsen TL, Sorensen JL. Play interventions for paediatric patients in hospital: a scoping review. BMJ Open. 2021 Jul 26;11(7):e051957. doi: 10.1136/bmjopen-2021-051957.
PubMed 34312210Davison G, Conn R, Kelly MA, Thompson A, Dornan T. Fifteen-minute consultation: Guide to communicating with children and young people. Arch Dis Child Educ Pract Ed. 2023 Apr;108(2):91-95. doi: 10.1136/archdischild-2021-323302. Epub 2021 Dec 2.
PubMed 34857651Hoeg BL, Sevillano PB, Enesco I, Wakefield CE, Larsen HB, Bidstrup PE. Child-centered communication interventions in pediatric oncology: A scoping review and proposed new communication model. Pediatr Blood Cancer. 2023 Jul 4:e30533. doi: 10.1002/pbc.30533. Online ahead of print.
PubMed 37401446Thestrup J, Sorensen JL, Bidstrup PE, Rosthoj S, Hybschmann J, Esbjorn BH, Dybdal D, Barslund K, Topperzer MK, Frandsen TL, Gjaerde LK. Effect on healthcare professionals' self-efficacy of a 45-min versus 3-hour educational intervention on communication and play in paediatric clinical practice in Denmark: a randomised controlled trial study protocol. BMJ Open. 2025 Sep 14;15(9):e101703. doi: 10.1136/bmjopen-2025-101703.
PubMed 40953883
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Healthcare Professionals' Self-efficacy of a 45-minute vs Three-hour Educational Intervention on Communication and Play in Paediatric Clinical Practice: A Randomised Controlled Trial Study Protocol
- ClinicalTrials.gov ID
- NCT06859632
- Acronym / sponsor ID
- P-2021-426
- Conditions
- Education, Communication, Play, Pediatrics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 5 Mar 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.
The goal for this trial is to test the effect of an educational programme on communication and play for healthcare professionals working with children and adolescents. The main questions to answer are:
- Does a 45-minute educational intervention on communication and play have the same effect on healthcare professionals' self-efficacy in patient-centredness compared with a three-hour intervention?
- What is the effect of the intervention on participants' motivation to engage in the educational activity, cognitive load, knowledge, satisfaction, and the impact on their individual practice ?
Participants will be randomly assigned to either a 45-minute or a three-hour educational intervention. They will complete a questionnaire at three time points: before the intervention, immediately after, and at a 12-week follow-up.
Detailed description
BACKGROUND: Communication is an essential skill for all healthcare professionals working with children and adolescents in hospitals. There is growing focus on child-centred communication, which emphasize communicating directly with children and adolescents in healthcare rather than focusing on the parents. However, educational programmes for this remain limited while those that exist are heterogenous and often assessed without comparison groups or validated tools.
OBJECTIVE: To investigate the effect on healthcare professionals' self-efficacy of a 45-minute vs three-hour educational intervention on communication and the use of play in clinical paediatric practice
INTERVENTION: This trial evaluates the educational programme "Communication and Play with Children and Adolescents in Healthcare", which focuses on age-appropriate communication with paediatric patients, including the deliberate use of play. The trial compares two educational interventions that differ in duration (45 minutes vs. three hours) and learning methods. While both interventions include didactic learning, reflection, and discussions, the three-hour session adds role-play activities, whereas the 45-minute session delivers a condensed version without role-play.
DESIGN: Single-centre, randomized, controlled, two-arm, noninferiority trial. A noninferiority design is used to assess whether there is a difference between the two educational interventions or if the 45-minute educational intervention is comparable to the three-hour educational intervention.
SETTING: The University Hospital of Copenhagen - Rigshospitalet, Denmark.
RECRUITMENT: All healthcare professionals working in the Department of Paediatrics and Adolescent Medicine at Rigshospitalet will be eligible to participate. Potential participants will be contacted by their leaders and be informed of the study. A written consent will then be obtained.
SAMPLE SIZE: The sample size calculation assumes that the 45-minute intervention is as effective as the three-hour intervention for the primary outcome (self-efficacy). A non-inferiority margin of 0.25 points is set, meaning the mean self-efficacy score for the 45-minute intervention can be up to 0.25 points lower than that of the three-hour intervention without being considered inferior. Based on a one-sided two-sample t-test with a margin of 0.25, an alpha of 0.025, a power of 80%, and a standard deviation of 0.45 derived from the pilot study, the required sample size is 52 participants per group. Since the intervention is conducted in clusters of 25 participants, the sample size calculation is adjusted for cluster randomization by multiplying by the design effect, calculated as 1 + (cluster size - 1) × ICC. Assuming an ICC of 0.01 results in a design effect of 1.24 and an adjusted sample size of 65 per group. Accounting for a 10% dropout rate, the final required sample size is 72 per group. It is planned to include a total of 150 participants.
RANDOMIZATION: Eligible participants will be randomly assigned in a 1:1 ratio to either a 45-minute educational intervention or a three-hour educational intervention using computer-generated block randomization through REDCap. The randomization process will ensure an interprofessional distribution of participants in each intervention group. Both the statistician and the researchers conducting the analysis will be blinded to participant allocation.
ETHICS: This trial complies with the principles outlined in the Declaration of Helsinki for biomedical research. Approval has been obtained from the Danish Data Protection Agency (P-2021-426). The study was approved but deemed exempt from requiring ethical approval by The Scientific Ethical Committees for the Capital Region of Denmark (Journal-nr.: H-21028050). Participation is entirely voluntary, and both educational interventions will take place during working hours at no cost to the participants. Participants may withdraw from the study at any time without any repercussions. To ensure confidentiality, all data will be securely stored in a protected database.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 45-minute educational intervention | Active comparator | Other: 45-minute educational interventionParticipants will receive a 45-minute educational intervention on communication and the use of play in paediatric clinical practice |
| 3-hour educational intervention | Experimental | Other: 3-hour educational interventionParticipants will receive a 3-hour educational intervention on communication and the use of play in paediatric clinical practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare professionals employed in the Department of Paediatrics and Adolescent Medicine at Rigshospitalet (nurses, doctors, physiotherapist, occupational therapists, dieticians, medical secretaries, and social workers)
- Provide signed informed consent before randomisation
Key exclusion criteria (2 listed)
- Staff taking part in planning of the intervention
- Lack of informed consent
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 |
|---|---|---|
| 3-hour educational interventionA 3-hour educational intervention on communication and the use of play in paediatric clinical practice. Participants in both arms will have access to written learning material and an app that has been developed. | Other | 3-hour educational intervention |
| 45-minute educational interventionA 45-minute educational intervention on communication and the use of play in paediatric clinical practice. Participants in both arms will have access to written learning material and an app that has been developed. | Other | 45-minute educational intervention |
Primary outcome
Self-efficacy
Time frame: From enrollment to 12-week follow-up
Self-efficacy measured using a 10-item questionnaire on a 5-point likert scale (1 = very low degree, 5 = very high degree). Questions are adapted from the Danish version of the validated Self-Efficacy in Patient-Centeredness Questionnaire (SEPCQ-27).This questionnaire evaluates participants' confidence in their ability to build relationships and communicate with children and adolescents in hospital settings.
5 secondary outcomes
Motivation
Time frame: Immediately after intervention
Self-evaluated knowledge about paediatric communication
Time frame: From enrollment to 12 week follow-up
Cognitive load
Time frame: Immediately after intervention
Satisfaction with intervention
Time frame: Immediately after intervention
Impact on individual practice and training need
Time frame: 12 week follow-up
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 10 Jul 2025.
- Background: PubMed 38098168Krebs CL, Thestrup J, Hybschmann J, Graber K, Gjaerde LK, Topperzer MK, Nielsen ET, Larsen A, Ramchandani P, Frandsen TL, Sorensen JL. A BEME review of educational programmes on the use of play in paediatric practice: BEME Guide No. 82. Med Teach. 2024 Nov;46(11):1393-1403. doi: 10.1080/0142159X.2023.2287983. Epub 2023 Dec 14.
- Background: PubMed 39663230Thestrup J, Sorensen JL, Esbjorn BH, Hybschmann J, Frandsen TL, DeCosta P, Gjaerde LK. Paediatric patient perceptions of healthcare professionals: contributions to a communication curriculum. Eur J Pediatr. 2024 Dec 12;184(1):75. doi: 10.1007/s00431-024-05911-x.
- Background: PubMed 38430279Jeppesen E, Schmidt AA, Skjodt CK, Hybschmann J, Gjaerde LK, Thestrup J, Hansson H, Sorensen JL. Educational programmes for paediatric healthcare professionals in patient- and family-centred care. A scoping review. Eur J Pediatr. 2024 May;183(5):2015-2028. doi: 10.1007/s00431-024-05455-0. Epub 2024 Mar 2.
- Background: PubMed 38183437Thestrup J, Sorensen JL, Hybschmann J, Topperzer MK, Graber K, O'Farrelly C, Gibson J, Ramchandani P, Frandsen TL, Gjaerde LK. Establishing consensus on principles and competencies for the use of play in clinical practice in hospitals: An international Delphi study. Eur J Pediatr. 2024 Apr;183(4):1595-1605. doi: 10.1007/s00431-023-05411-4. Epub 2024 Jan 6.
- Background: PubMed 34312210Gjaerde LK, Hybschmann J, Dybdal D, Topperzer MK, Schroder MA, Gibson JL, Ramchandani P, Ginsberg EI, Ottesen B, Frandsen TL, Sorensen JL. Play interventions for paediatric patients in hospital: a scoping review. BMJ Open. 2021 Jul 26;11(7):e051957. doi: 10.1136/bmjopen-2021-051957.
- Background: PubMed 34857651Davison G, Conn R, Kelly MA, Thompson A, Dornan T. Fifteen-minute consultation: Guide to communicating with children and young people. Arch Dis Child Educ Pract Ed. 2023 Apr;108(2):91-95. doi: 10.1136/archdischild-2021-323302. Epub 2021 Dec 2.
- Background: PubMed 37401446Hoeg BL, Sevillano PB, Enesco I, Wakefield CE, Larsen HB, Bidstrup PE. Child-centered communication interventions in pediatric oncology: A scoping review and proposed new communication model. Pediatr Blood Cancer. 2023 Jul 4:e30533. doi: 10.1002/pbc.30533. Online ahead of print.
- Derived from this study: PubMed 40953883Thestrup J, Sorensen JL, Bidstrup PE, Rosthoj S, Hybschmann J, Esbjorn BH, Dybdal D, Barslund K, Topperzer MK, Frandsen TL, Gjaerde LK. Effect on healthcare professionals' self-efficacy of a 45-min versus 3-hour educational intervention on communication and play in paediatric clinical practice in Denmark: a randomised controlled trial study protocol. BMJ Open. 2025 Sep 14;15(9):e101703. doi: 10.1136/bmjopen-2025-101703.
- Individual participant dataSharing planned: No. De-identified individual participant data to replicate the analysis will be available from the corresponding author (ORCID: 0000-0002-0093-8555) on reasonable request until five years after completion of the study, according to Danish law.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-hour educational intervention and 45-minute educational intervention in people with Education and Communication, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2025. 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 Denmark. 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?
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?
Self-efficacy (time frame: From enrollment to 12-week follow-up). 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 NCT06859632, which also lists 8 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 10 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.