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Multisensory StimulationNCT07769775

The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children

A study testing Multisensory stimulation in people with Multisensory Stimulation and Pain, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

Venipuncture is one of the most common and distressing needle-related procedures for children, often causing significant pain, fear, and anxiety. To minimize this procedural distress, effective non-pharmacological interventions are essential in pediatric nursing care. Read more about this study

Who is it for?
Ages 5 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Multisensory Stimulation, Pain, Venipuncture Pain
What is being tested?
Multisensory stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2025to 1 Sep 2026
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 5 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 5 to 10 years
  • Having passed at least 2 hours since the most recent painful procedure
  • Provision of parental/guardian informed consent for participation

Who cannot join

  • Presence of visual or hearing impairment
  • Presence of intellectual/cognitive disability
  • Absence or lack of signed Parental Informed Consent Form

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bilecik Seyh Edebali University

    Bilecik, Turkey

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children: A Randomized Controlled Trial

Venipuncture is one of the most common and distressing needle-related procedures for children, often causing significant pain, fear, and anxiety. To minimize this procedural distress, effective non-pharmacological interventions are essential in pediatric nursing care.

Read the detailed description

Children encounter many situations in the hospital environment that trigger pain, fear, and anxiety. The unfamiliarity of the physical environment, the appearance of medical devices, interventions by healthcare professionals, and the unpredictability of routine procedures are cited as important factors that increase children's levels of pain, fear, and anxiety. Children with chronic illnesses, in particular, face numerous painful procedures during diagnosis, treatment, and follow-up, while healthy children also experience pain due to reasons such as venipuncture and repeated invasive procedures. Venipuncture, one of the most commonly used and fundamental procedures in healthcare delivery, can be a traumatic experience, especially for children.This procedure can cause intense pain, anxiety, and fear in children, leading to negative psychological reactions in the short term and the development of negative attitudes toward healthcare services in the long term.The literature indicates that such negative attitudes not only adversely affect the success of the procedure but also manifest themselves in the child as physical resistance, crying, avoidance behavior, and increased physiological stress indicators.These behavioral and physiological responses can lead to problems for healthcare professionals, such as prolonged procedure times, multiple attempts, and increased procedural complexity; this situation can cause anxiety for both the child and the healthcare worker. Furthermore, it has been reported that negative experiences during painful procedures such as venipuncture can lead to psychosocial consequences in children, including long-term fear, avoidance of medical procedures, needle phobia, and the formation of traumatic memories. The high levels of anxiety and fear experienced by children during this process can reduce their compliance with healthcare services in later years and lead to mistrust of healthcare professionals. Numerous studies in the literature have determined that the anxiety and fear experienced by children during venipuncture are among the key factors that significantly affect the quality of the procedural process .Therefore, reducing pain, fear, and anxiety that may develop during venipuncture in children is critically important for both protecting the child's short- and long-term well-being and increasing the effectiveness of clinical practice. Although venipuncture is a painful medical procedure, it is one of the situations that causes significant anxiety and fear in children in a hospital setting.Research in the literature on non-pharmacological methods to control pain and reduce anxiety and fear suggests the use of multisensory stimulation to distract children and create a happy and motivating atmosphere.

Multisensory stimulation is a non-pharmacological method that aims to support a child's developmental stages using stimulating materials targeting the senses of sight, hearing, smell, and touch, with the goal of reducing behavioral problems, pain, and fear.The basic mechanism of multisensory stimulation is to provide multiple stimuli by continuously activating the tactile, thermal, and emotional systems. This simultaneous stimulation of various sensory systems leads to sensory saturation. This activates the gate control mechanism to close the gates, thereby weakening or suppressing nociceptive transmission. Thus, the gate control mechanism reduces or eliminates pain by closing the gates to prevent the entry of nociceptive signals. Multiple sensory stimulation practices include mother-infant communication, skin-to-skin contact, breastfeeding that activates skin sensory receptors and the sense of taste, and allowing the infant to smell familiar scents such as breast milk, amniotic fluid, or aromatic scents. Establishing eye contact with the infant, speaking in a soft tone of voice, massage, swaddling, and using the parent's scent are also among the multisensory stimulation practices.

Non-pharmacological methods are known to be effective in reducing pain in children and to increase the effectiveness of medications when used in combination with analgesics.Non-pharmacological methods are preferred because they are easy to apply and inexpensive, reducing the need for medication and thus the risk of side effects. Knowing the effects of pain and the associated fear and anxiety on children, developing appropriate pain control strategies is both a medical and ethical responsibility. A review of the literature reveals that there is very little scientific evidence that multisensory stimulation is an effective intervention for reducing pain, fear, and anxiety in children during venipuncture.Recent research in the literature on non-pharmacological methods for pain control and reducing anxiety and fear recommends the use of multisensory stimulation in children. Some studies have examined the effects of multisensory stimulation applications on children's health. These studies have mostly focused on the effects during the neonatal period.Although there are a limited number of studies aimed at reducing pain, fear, and anxiety during venipuncture in children, these studies are limited to methods that focus on only one sense or at most two sensory stimuli.Therefore, our study contributes to the limited literature evaluating the effect of multisensory stimulation by using Happy Senso Therapy foam, which simultaneously stimulates the senses of touch, sight, hearing, and smell. In this context, the aim of our study is to examine the effect of multisensory stimulation applied during venipuncture in children on pain, anxiety, and fear.

Being tested
Multisensory stimulation
Keywords
child, pain, fear, anxiety, venipuncture, multisensory stimülation
Medical subject headings
Pain, Anxiety Disorders

What participants receive

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

  • Multisensory stimulationOther

    Happy Senso Therapy foam is a gel with multisensory properties. It stimulates the senses of touch, sight, hearing, and smell simultaneously in a fun way. It is a material used for sensory stimulation. It provides a cooling and fun effect that feels like "popping candy" on your skin. It evaporates at the end of the ses-sion, leaving no residue. It does not require washing. It has been dermatologically tested. It is paraben-free and hypoallergenic. It is used in therapy applications, as a work, play, and educational material. It is noted to be useful for increasing the child's attention span to the ac-tivity, boosting motivation, and reducing pain and fear. It helps increase interaction between the nurse and the child.

Study groups in NCT07769775
Study groupRoleWhat they receive
The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in ChildrenExperimentalA Randomized Controlled Trial
Receives: Other: Multisensory stimulation

What is being measured

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

  1. Child's Pain Level

    Wong Baker Facial Pain Rating Scale The scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 2013. This scale is used to assess pain in children aged 3-18 years. The scale is rated from 0 to 10. 0 indicates no pain, while 10 indicates the most severe pain. Pain is assessed based on facial expression.

    Measured: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).

Secondary outcomes (1)
  1. Child's Anxiety Level

    It assesses children's anxiety in clinical settings and before medical procedures. The Child Anxiety Meter (CAM) is drawn like a thermometer with a bulb at the bottom and also contains horizontal lines spaced upward. Children are asked to mark how they feel "right now" to measure state anxiety (CAM-S).Scores range from 0 to 10. It has been validated in children aged 4-10 years during an intravenous procedure. CAM-S scores were significantly correlated with all parent measures and observed distress ratings. The psychometric properties of CAM in the Turkish population were examined by Özalp Gerçeker and colleagues (2018), who found a significant negative correlation between children's anxiety scores and their age.

    Measured: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).

Timeline

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

  1. First posted18 Aug 2026
  2. Study start1 Oct 2025
  3. Primary completion15 Aug 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Why it stopped: The study has been temporarily suspended due to a low volume of patient admissions and clinical encounters at the outpatient clinic during the summer period. Data collection is planned to resume once patient flow normalizes.

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07769775
Sponsor's protocol ID
Bilecik-BSEU2
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol. Specifically: Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories. Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity. De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.

Publications

  • No publications resulting from this study are available at this time as the trial is currently ongoing.

Questions about this trial

What is this clinical trial studying?

A study testing Multisensory stimulation in people with Multisensory Stimulation and Pain, run by Bilecik Seyh Edebali Universitesi 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 3 inclusion and 3 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: paused, as of the sponsor's last update on 19 Aug 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 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?

Results are not available in the source record.

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?

Child's Pain Level (time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).). 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 NCT07769775, 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 19 Aug 2026.

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