Evaluation of a playful VR intervention for children and their caregivers to reduce pain, anxiety, and stress during painful procedures

Evaluation of a playful VR intervention for children and their caregivers to reduce pain, anxiety, and stress during painful procedures - SweetDiveVR

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033544

Enrollment

Registered

2024-02-01

Start date

2024-03-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Port puncturing Lumbar puncture Peripheral/central venous catheter insertion Kirschner-wire removal

Interventions

Group 1: Cooperative, asymmetric VR game played by the patient and a caregiver during the procedure (1 Session, ca 7 minutes, one-time) Group 2: Audio recording of crashing waves played during the pro

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: - Procedure possible without sedation - Sufficient knowledge of the German language by patient and carergiver

Exclusion criteria

Exclusion criteria: - Visual impairments (e.g., stereo vision disorders, color blindness, severe defective vision) - Severe cognitive impairments - Epilepsy

Design outcomes

Primary

Measure	Time frame
Subjective pain, anxiety, and stress experience of the patient measured with STAIK (State-Trait-Anxiety Inventory for Children), VAS Anxiety and VAS Pain (Visual Analog Scale), and PANAS-K (Positive Affect Negative Affect Schedule for Children) . Measurement directly before the procedure (pre) and directly after the procedure (post).	—

Secondary

Measure	Time frame
Subjective anxiety and stress experience of the caregiver, measured with STAI (State-Trait-Anxiety Inventory) and PANAS (Positive Affect Negative Affect Schedule). Measurement directly before (pre) and after (post) the procedure. Player experience of patient and caregiver, measured with PXI (Player Experience Inventory), directly after the procedure (post) Patient experience (i.e. feelings during the procedure) with self-formulated items after (post) the procedure. Interviewer assessment of the procedure, the patient's emotional experience, and cooperativeness as well as the gameplay using observation protocol with self-formulated items, VAS anxiety/pain and CHEOPS (Children's Hospital of Eastern Ontario Pain Scale). Measurement during the procedure.	—

Measure

Time frame

Subjective anxiety and stress experience of the caregiver, measured with STAI (State-Trait-Anxiety Inventory) and PANAS (Positive Affect Negative Affect Schedule). Measurement directly before (pre) and after (post) the procedure. Player experience of patient and caregiver, measured with PXI (Player Experience Inventory), directly after the procedure (post) Patient experience (i.e. feelings during the procedure) with self-formulated items after (post) the procedure. Interviewer assessment of the procedure, the patient's emotional experience, and cooperativeness as well as the gameplay using observation protocol with self-formulated items, VAS anxiety/pain and CHEOPS (Children's Hospital of Eastern Ontario Pain Scale). Measurement during the procedure.

—

Countries

Germany

Contacts

Public ContactStefan Liszio

Universitätsklinikum Essen

stefan.liszio@uk-essen.de02017231907

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026