About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

Psychoeducational single-session intervention for families during the perioperative period
Behavioral
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.

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: Single-session psychoeducational interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

3-4 weeks after the surgery

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

3 to 4 weeks after surgery

Other outcomes

1

Use of the application of the single-session intervention

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.

Time frame

3-4 weeks after the surgery

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts