Pain ManagementMSPSDNCT06959823
Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief
A study testing Multisensory Pediatric Support Device (MSPSD) in people with Pain Management and Anxiety, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Pain and anxiety are common responses in pediatric patients undergoing invasive procedures and can negatively affect both immediate care outcomes and future health-care experiences. Non-pharmacological interventions, especially those involving multisensory distraction, are increasingly used to alleviate distress. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pain Management, Anxiety
- What is being tested?
- Multisensory Pediatric Support Device (MSPSD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized in the pediatric surgery ward.
- Undergoing an invasive intervention (e.g., intravenous catheter insertion, intramuscular injection, wound care) for the first time during their hospital stay.
- Able to communicate and understand simple instructions.
- Written informed consent obtained from legal guardians and verbal assent from the child (as appropriate to developmental level).
Who cannot join
- Children with cognitive impairments or developmental delays that prevent communication or reliable self-reporting.
- Children with previous experience of invasive procedures during the current hospitalization.
- Children receiving sedation or pharmacological anxiolytics before the procedure.
- Children or legal guardians who refuse to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul
About this study
Official title: Evaluation of the Effect of the Integrated Innovative Bed Apparatus Developed for the Relief of Pain and Anxiety in Pediatric Patients
Pain and anxiety are common responses in pediatric patients undergoing invasive procedures and can negatively affect both immediate care outcomes and future health-care experiences. Non-pharmacological interventions, especially those involving multisensory distraction, are increasingly used to alleviate distress. This study aimed to evaluate the effectiveness of a novel, child-friendly, multisensory support device in reducing pain and anxiety in pediatric surgical patients.
Keywords: child, pain, anxiety, distraction, pediatrics, innovative device
Read the detailed description
This randomized controlled trial included 48 children aged 4-12 years who were hospitalized in the pediatric surgery unit of a tertiary hospital in Istanbul, Turkey, and who underwent an invasive procedure for the first time. Participants were randomly assigned to either the intervention (n=24) or control group (n=24) using block randomization based on age and sex. The intervention group received a Multisensory Pediatric Support Device that delivered combined audio (storybook narration), visual (lights), and animated stimuli during the procedure. The control group received standard preoperative and postoperative care. Pain and anxiety were measured using the Wong-Baker FACES Pain Rating Scale and the Children's Anxiety Meter State (CAM-S), respectively.
- Conditions
- Pain Management, Anxiety
- Being tested
- Multisensory Pediatric Support Device (MSPSD)
- Keywords
- child, pain, anxiety, distraction, innovative device
- Medical subject headings
- Agnosia, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory Pediatric Support Device (MSPSD)Device
Child-friendly multisensory device providing audio-visual distraction during invasive procedures.
| Study group | Role | What they receive |
|---|---|---|
| MSPSD Intervention Group | Experimental | Participants received multisensory pediatric support device (MSPSD) during invasive procedures. Receives: Device: Multisensory Pediatric Support Device (MSPSD) |
| Standard Care Group | No intervention | Participants received standard care without any multisensory device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score Change
Assessed by Wong-Baker FACES Pain Rating Scale (min: 0, max: 10)
Measured: Before and immediately after invasive procedure.
Anxiety Score Change
Assessed by Children's Anxiety Meter State (CAM-S) (min: 0, max: 30)
Measured: Before and immediately after invasive procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start2 Apr 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evin Korkmaz, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959823
- Sponsor's protocol ID
- MSPSD-2024-01
- Other IDs
- TUBITAK-2024-003625
- Acronym
- MSPSD
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results will be made available to qualified researchers upon reasonable request. Data requests should be directed to the principal investigator via email (dr.evinkorkmaz@gmail.com). Data will be shared after publication, with a data use agreement.
Publications
Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.
PubMed 24108531
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Integrated Innovative Bed Apparatus Developed for the Relief of Pain and Anxiety in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06959823
- Acronym / sponsor ID
- MSPSD / MSPSD-2024-01
- Conditions
- Pain Management, Anxiety
- Keywords
- child, pain, anxiety, distraction, innovative device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 7 May 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.
Pain and anxiety are common responses in pediatric patients undergoing invasive procedures and can negatively affect both immediate care outcomes and future health-care experiences. Non-pharmacological interventions, especially those involving multisensory distraction, are increasingly used to alleviate distress. This study aimed to evaluate the effectiveness of a novel, child-friendly, multisensory support device in reducing pain and anxiety in pediatric surgical patients.
Keywords: child, pain, anxiety, distraction, pediatrics, innovative device
Detailed description
This randomized controlled trial included 48 children aged 4-12 years who were hospitalized in the pediatric surgery unit of a tertiary hospital in Istanbul, Turkey, and who underwent an invasive procedure for the first time. Participants were randomly assigned to either the intervention (n=24) or control group (n=24) using block randomization based on age and sex. The intervention group received a Multisensory Pediatric Support Device that delivered combined audio (storybook narration), visual (lights), and animated stimuli during the procedure. The control group received standard preoperative and postoperative care. Pain and anxiety were measured using the Wong-Baker FACES Pain Rating Scale and the Children's Anxiety Meter State (CAM-S), respectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSPSD Intervention Group | Experimental | Device: Multisensory Pediatric Support Device (MSPSD)Participants received multisensory pediatric support device (MSPSD) during invasive procedures. |
| Standard Care Group | No intervention | –Participants received standard care without any multisensory device. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Hospitalized in the pediatric surgery ward.
- Undergoing an invasive intervention (e.g., intravenous catheter insertion, intramuscular injection, wound care) for the first time during their hospital stay.
- Able to communicate and understand simple instructions.
- Written informed consent obtained from legal guardians and verbal assent from the child (as appropriate to developmental level).
Key exclusion criteria (4 listed)
- Children with cognitive impairments or developmental delays that prevent communication or reliable self-reporting.
- Children with previous experience of invasive procedures during the current hospitalization.
- Children receiving sedation or pharmacological anxiolytics before the procedure.
- Children or legal guardians who refuse to provide 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 |
|---|---|---|
| Multisensory Pediatric Support Device (MSPSD)Child-friendly multisensory device providing audio-visual distraction during invasive procedures. | Device | MSPSD Intervention Group |
Primary outcome
Pain Score Change
Time frame: Before and immediately after invasive procedure.
Assessed by Wong-Baker FACES Pain Rating Scale (min: 0, max: 10)
Anxiety Score Change
Time frame: Before and immediately after invasive procedure.
Assessed by Children's Anxiety Meter State (CAM-S) (min: 0, max: 30)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Background: PubMed 24108531Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results will be made available to qualified researchers upon reasonable request. Data requests should be directed to the principal investigator via email (dr.evinkorkmaz@gmail.com). Data will be shared after publication, with a data use agreement.
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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 Multisensory Pediatric Support Device (MSPSD) in people with Pain Management and Anxiety, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 7 May 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Score Change (time frame: Before and immediately after invasive procedure.). The study lists 2 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 NCT06959823, 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 7 May 2025.