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

Organizational Data

DRKS-ID:
DRKS00033544
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2024-02-01
Last update in DRKS:
2024-03-15
Registration type:
Prospective

Acronym/abbreviation of the study

SweetDiveVR

URL of the study

https://sweetdivevr.ume.de

Brief summary in lay language

Needle punctures are painful and frightening for many patients. Children sometimes experience extreme anxiety and stress. This makes the treatment situation an additional psychological burden. They suffer and often react with strong defensive reactions and a reduced willingness to cooperate. This makes the treatment even more difficult and increases the risk of an unsuccessful puncture. But it is not only the children themselves who experience anxiety and stress during the treatment. It is also sometimes difficult for the caregivers (e.g. parents) to bear seeing their own child suffer. Especially with younger children, who are still unconcerned when they first enter such a situation, the anxiety and excitement of those accompanying them before and during the procedure is often transferred to the child. Our approach is based on the use of virtual reality. Patients wear a VR headset that shields them from the environment of the treatment room and immerses them in a colorful, peaceful underwater world. Our approach of involving the caregiver in the game is particularly innovative. Together, patients and caregivers have to keep exotic fish away from sweets that have fallen from a capsized candy delivery ship. As only the patients can see the underwater world, they have to give instructions to their caregiver to trigger actions in the game. The result is a dynamic, interactive and cooperative gameplay that engages both the patients and their caregiver and distracts them from the treatment. In this way, we hope to reduce patients' pain, create a relaxed atmosphere for everyone involved in the procedure and increase their well-being during the procedure.

Brief summary in scientific language

Attention is a limited cognitive resource. That is, the more we focus on a sensation or a thought, the fewer resources are available for other cognitive processes. The distraction therapy approach makes use of this fact. By exposing patients to cognitively absorbing, positive stimuli, the aim is to reduce the salience of negative stimuli and thoughts. The mental immersion effect characteristic to digital games is based on this very principle. VR technology works by blocking out real stimuli and replacing them with simulated stimuli. Games played with VR technology therefore combine mental and perceptual immersion effects, whereby maximum distraction is achieved. Given the many positive results reported in the literature, we believe that VR games are an effective way to distract pediatric patients from pain and anxiety during various medical procedures. To our knowledge, it has not yet been investigated whether the use of a multiplayer game as a distraction and relaxation intervention also influences anxiety, stress and worry in the accompanying persons and at the same time improves the patients' emotional experience and perception of pain. This question is to be answered in the present prospective, randomized clinical trial.

Health condition or problem studied

Free text:
Port puncturing
Free text:
Lumbar puncture
Free text:
Peripheral/central venous catheter insertion
Free text:
Kirschner-wire removal
Healthy volunteers:
No

Interventions, Observational Groups

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

Endpoints

Primary outcome:
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 outcome:
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.

Study Design

Purpose:
Other
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
Random allocation by study management software upon enrollment of the patient
Blinding:
No
Assignment:
Parallel
Sequence generation:
Stratification based on: 1. Trait anxiety (STAIK-T) 2. Age 3. Type of intervention 4. Previous experience 5. Sex
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Universitätsklinikum Essen Essen
  • University medical center Universitätsklinikum Hamburg-Eppendorf Hamburg
  • University medical center Universitätsklinikum Schleswig-Holstein Lübeck

Recruitment period and number of participants

Planned study start date:
2024-02-12
Actual study start date:
2024-03-14
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
75
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
6 Years
Maximum Age:
12 Years
Additional Inclusion Criteria:
- Procedure possible without sedation - Sufficient knowledge of the German language by patient and carergiver

Exclusion Criteria

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

Addresses

Primary Sponsor

Universitätsklinikum Essen
Dr. med. Oliver Basu
Hufelandstraße 55
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uk-essen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Essen
Dr. rer. nat. Stefan Liszio
Hufelandstraße 55
45147 Essen
Germany
Telephone:
02017231907
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uk-essen.de

Contact for Public Queries

Universitätsklinikum Essen
Dr. rer. nat. Stefan Liszio
Hufelandstraße 55
45147 Essen
Germany
Telephone:
02017231907
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uk-essen.de

Principal Investigator

Universitätsklinikum Essen
Dr. rer. nat. Stefan Liszio
Hufelandstraße 55
45147 Essen
Germany
Telephone:
02017231907
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uk-essen.de

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Essen AöR
Hufelandstraße 55
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uk-essen.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
Robert-Koch-Str. 9-11
45147 Essen
Germany
Telephone:
+49-201-7233637
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-due.de/ethikkommission/

Vote of leading Ethics Committee

Date of ethics committee application:
2022-08-15
Ethics committee number:
22-10873-BO
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-10-11

Other Address Ethics Committee

Ethik-Kommission der Ärztekammer Hamburg
Weidestraße 122 b
22083 Hamburg
Germany
Telephone:
+49-40-202299240
Fax:
No Entry
Contact per E-Mail
URL:
http://www.aerztekammer-hamburg.org/ethikkommission.html

Vote of the Ethics Committee

Vote of the Ethics Committee:
Approved
Date of the vote:
2023-05-02

Other Address Ethics Committee

Ethik-Kommission der Universität zu Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
+49-451-31011026
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-luebeck.de/forschung/kommissionen/ethikkommission.html

Vote of the Ethics Committee

Vote of the Ethics Committee:
Approved
Date of the vote:
2023-10-12

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry