The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children
The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Turkey
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Bilecik, Turkey, Turkey (Türkiye)
- Bilecik Seyh Edebali University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Presence of visual or hearing impairment
- Presence of intellectual/cognitive disability
- Absence or lack of signed Parental Informed Consent Form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children
A Randomized Controlled Trial
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Child's Pain Level
Time Frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
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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.
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Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Child's Anxiety Level
Time Frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
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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.
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Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Child's Fear Level
Time Frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
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The Child Fear Scale (CFS), the validity and reliability of which was conducted by Gerçeker et al. (2018), is used to measure the child's anxiety level.
The PSS is a 0-4 scale consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to scared face (4=severe anxiety).
It can be used by families and researchers to assess pain and anxiety in children before and during the procedure and is intended for children aged 5-10 years (McMurtry et al., 2011).
The CQS was created based on the Faces Anxiety Scale developed by McKinley et al. (2003) to measure the fear or anxiety of adults hospitalized in the intensive care unit.
It is a scale consisting of one item and five gender-neutral faces.
The facial muscle changes in fearful expressions were drawn by a graphic artist based on photographs of the faces.
For the ACS, the total size of the Faces Anxiety Scale was reduced to match the size of the Child Anxiety and Pain Scale, but the drawings were not changed.
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Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
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Collaborators and Investigators
Publications and helpful links
General Publications
- No publications resulting from this study are available at this time as the trial is currently ongoing.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bilecik-BSEU2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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