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Pediatric Orthopedic SurgeryPOPINCT07812961

A Short Digital Intervention for Youth Undergoing Major Surgery and Their Parents

A study testing Psychoeducational single-session intervention for families during the perioperative period in people with Pediatric Orthopedic Surgery, run by Helen Koechlin at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The perioperative time, i.e., the time before, during, and directly after surgery, can be stressful for families whose child needs to undergo major orthopedic surgery. Families have expressed their need for more and easily accessible information on what to expect before and after surgery, and how to deal with… Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Pediatric Orthopedic Surgery
What is being tested?
Psychoeducational single-session intervention for families during the perioperative period
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSwitzerland
Study dates
Oct 2026to Jan 2027
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 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • the patient is between 8 and 18 years of age;
  • the patient has a scheduled orthopedic surgery requiring inpatient care for at least one night at one of the participating hospitals;
  • the patient and at least one parent/caregiver are able to read and understand German;
  • both the patient and the parent/caregiver agree to participate in the study and to test the digital single-session intervention.

Who cannot join

  • the patient has a serious comorbid medical condition that may substantially affect perioperative recovery or study participation (e.g., cancer, severe neurological impairment, chronic illness requiring daily medication);
  • the patient has undergone previous major orthopedic surgery (e.g., prior spine surgery);
  • the patient or caregiver is unable to follow study procedures due to cognitive, psychological, or language-related difficulties;
  • either the patient or one of the parents/caregivers declines participation in the study or declines testing of the intervention.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Helen Koechlin, PhD contact

+4144 249 63 08

helen.koechlin@uzh.ch

Patrizia Steiner, MD contact

patrizia.steiner@kispi.uzh.ch

Switzerland1 site

  • University Children's Hospital Zurich

    Zurich, 8008

    Helen Koechlin, PhD, +4144 249 63 08, helen.koechlin@uzh.ch

Other trials in Switzerland

About this study

Official title: Pediatric Perioperative Pain Intervention (POPI): A Pilot Feasibility Study of a Psychoeducational Digital Single-Session Intervention

The perioperative time, i.e., the time before, during, and directly after surgery, can be stressful for families whose child needs to undergo major orthopedic surgery. Families have expressed their need for more and easily accessible information on what to expect before and after surgery, and how to deal with postoperative pain.

Single-session interventions are short interventions, often digital, that are scalable and present as a low-threshold approach for psychoeducational purposes. Previous studies have demonstrated good feasibility and acceptability of single-session interventions for psychosocial problems such as perioperative anxiety among families.

Therefore, in this pilot study, the investigators will test a newly developed digital single-session intervention for youth undergoing major orthopedic surgery and their parents. The intervention will provide pain education, general and individual resources, and a special module for parents on how they can best support their children. In this study, the investigators will evaluate if participants use the digital intervention, if they perceive the content as useful and the format as engaging, and whether there are aspects that need to be added or changed.

Being tested
Psychoeducational single-session intervention for families during the perioperative period
Keywords
children and adolescents, parents, pain education, perioperative period, single-session intervention, pilot study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychoeducational single-session intervention for families during the perioperative periodBehavioural

    The intervention is digital, and there is a separate version for youth with a planned surgery and for their parents.

    The intervention contains four main components:

    1. Psychoeducation on pain and pain management, information concerning hospitalization, general information about anesthesia and surgery, and coping strategies.
    2. Peer testimonials in the form of brief supportive statements (written/audio) from former patients and caregivers describing strategies and experiences they found helpful during the perioperative period.
    3. Activity section for participants, where they select and rank coping strategies and supportive tips from a list.
    4. Action plan based on the activites selected (see step 3) that are automatically transferred into a personalized action plan section. Participants may also add more strategies and a preferred support contact person to contact in emotionally challenging situations.
Study groups in NCT07812961
Study groupRoleWhat they receive
Single-session psychoeducational interventionExperimentalParticipants will receive access to a digital single-session intervention that provides them with pain education, resources in the hospital, a personal action plan, and information for parents on how to best support their children.
Receives: Behavioral: Psychoeducational single-session intervention for families during the perioperative period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Qualitative assessment of feasibility of the single-session intervention

    Semi-structured interviews will be conducted with the patient and one of their caregivers after surgery via zoom. Interviews will be audio-recorded and transcribed for analysis. These qualitative interviews will allow for an in-depth exploration of user experiences, barriers, facilitators, and perceived usefulness of the intervention.

    Measured: 3-4 weeks after the surgery.

  2. Qualitative assessment of the usability of the single session intervention

    Semi-structured interviews will be conducted with the patient and one of their caregivers after surgery via zoom. Interviews will be audio-recorded and transcribed for analysis. These qualitative interviews will allow for an in-depth exploration of user experiences, barriers, facilitators, and perceived usefulness of the intervention.

    Measured: 3-4 weeks after the surgery

  3. Qualitative assessment of the acceptability of the single-session intervention

    Semi-structured interviews will be conducted with the patient and one of their caregivers after surgery via zoom. Interviews will be audio-recorded and transcribed for analysis. These qualitative interviews will allow for an in-depth exploration of user experiences, barriers, facilitators, and perceived usefulness of the intervention.

    Measured: 3-4 weeks after the surgery

Secondary outcomes (4)

  1. Quantitative assessment of feasibility of the single-session intervention

    Secondary endpoints include the quantitative assessment of feasibility using the German version of the Feasibility of Intervention Measure (FIM) This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. The FIM has demonstrated strong content validity, reliability, and responsiveness to change. All items are rated on a 5-point Likert scale ranging from "1 - completely disagree" to "5 - completely agree". For descriptive interpretation, responses of 4 ("agree") and 5 ("completely agree") will be considered indicative of a positive evaluation.

    Measured: 3 to 4 weeks after surgery

  2. Quantitative assessment of usability of the single-session intervention

    Secondary endpoints include the quantitative assessment of usability using the German version of the System Usability Scale (SUS). This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. All items are rated on a 5-point Likert scale ranging from "1 - completely disagree" to "5 - completely agree". For descriptive interpretation, responses of 4 ("agree") and 5 ("completely agree") will be considered indicative of a positive evaluation.

    Measured: 3 to 4 weeks after surgery

  3. Quantitative assessment of acceptability of the single-session intervention

    Secondary endpoints include the quantitative assessment of acceptability using the German version of the Acceptability of Intervention Measure (AIM). This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. The AIM has demonstrated strong content validity, reliability, and responsiveness to change. All items are rated on a 5-point Likert scale ranging from "1 - completely disagree" to "5 - completely agree". For descriptive interpretation, responses of 4 ("agree") and 5 ("completely agree") will be considered indicative of a positive evaluation.

    Measured: 3 to 4 weeks after surgery

  4. Quantitative assessment of appropriateness of the single-session intervention

    Secondary endpoints include the quantitative assessment of appropriateness using the German version of the Intervention Appropriateness Measure (IAM). This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. The IAM have demonstrated strong content validity, reliability, and responsiveness to change. All items are rated on a 5-point Likert scale ranging from "1 - completely disagree" to "5 - completely agree". For descriptive interpretation, responses of 4 ("agree") and 5 ("completely agree") will be considered indicative of a positive evaluation.

    Additional secondary endpoints include the proportion of participants with at least one use of the application before surgery and at least one use after surgery.

    Measured: 3 to 4 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
This is a pilot study assessing feasibility, usability, and acceptability of a new digital intervention.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07812961
Sponsor's protocol ID
208850 (Grant ID)
Other IDs
208850
Acronym
POPI
Status last verified
Sep 2026
First submitted
31 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Coding queries will be shared, as they offer greater anonymity compared with full transcripts. All data will be anonymized before sharing.

Publications

  • Hochreuter J, Nissen EK, Locher C, Schleider JL, Bhend S, Koechlin H. The true experts: codeveloping a preventive psychological intervention for postsurgical pain with patients and caregivers. Pain Rep. 2026 Apr 28;11(3):e1445. doi: 10.1097/PR9.0000000000001445. eCollection 2026 Jun.

    PubMed 42077593

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducational single-session intervention for families during the perioperative period in people with Pediatric Orthopedic Surgery, run by Helen Koechlin at 1 site in Switzerland.

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: opening soon, as of the sponsor's last update on 10 Sep 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 Switzerland. 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 Helen Koechlin, PhD (+4144 249 63 08, helen.koechlin@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative assessment of feasibility of the single-session intervention (time frame: 3-4 weeks after the surgery.). 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 NCT07812961, which also lists 1 linked publication.

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 Sep 2026.

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