Multisensory StimulationNCT06237894
Multisensory Stimulation on Postoperative Pain, Physiological Parameters and Fear in Children
A study testing Multisensory Stimulation in people with Multisensory Stimulation and Child, Only, run by Bilecik Seyh Edebali Universitesi.
Trial summary
It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the… 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, Child, Only, Postoperative Pain
- What is being tested?
- Multisensory Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Jun 2025
- 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
None listed.
Who cannot join
- Hearing and vision impaired
- Does not have a mental disability
- Children who do not have a parental consent form will not be included in the research.
About this study
Official title: Effect of Multisensory Stimulation on Postoperative Pain, Physiological Parameters and Fear in Children After Surgical Procedure: Randomized Controlled Study
It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the risk of side effects. Knowing the impact of pain and associated fear on children, developing appropriate pain control strategies is both a medical and ethical responsibility. Reviewing the literature, there is little scientific evidence that multisensory stimulation is an effective intervention in reducing pain and fear after surgery in children. When the studies on the effect of multisensory stimulation on pain and fear in childhood are examined, it is seen that the studies mostly aim to reduce pain and fear in the neonatal period or before surgery. It is thought that it is an important limitation that multisensory stimulation, which is an effective method for reducing pain and fear in childhood, does not examine its direct effects on postoperative pain, physiological parameters and fear after surgical procedures in children. In this context, the aim of the study is to examine the effect of multisensory stimulation on postoperative pain, physiological parameters and fear in children after the surgical procedure.
Read the detailed description
The causes of surgery seen in childhood vary according to age. Congenital anomalies are the most common in the neonatal period, and in other age periods, the most common are gastrointestinal system (appendicitis, intussusception, inguinal hernia, etc.) and urogenital system surgeries (circumcision, hydrocele, undescended testicle, testicular torsion, hypospadias, laparoscopic interventions, ovarian cyst and torsion, etc.). They may undergo surgical procedures due to reasons such as .). In a child undergoing a surgical procedure; Postoperative complications such as apnea, airway obstruction, aspiration, extubation, laryngospasm, bronchospasm may occur. One of the most common problems seen in children after surgical procedures is pain. Studies have shown that 24-80% of children who undergo surgery are accompanied by moderate to severe pain. If postoperative pain is not relieved effectively, it may cause negative physiological effects such as increased respiration and pulse, decreased saturation, crying, restlessness, nausea and vomiting, oliguria, impaired immune response, decreased wound healing, and anorexia.
One of the most common problems seen in children after surgical procedures is fear. Postoperative pain that occurs after surgery, different environment and change of routine, different sounds, lights and equipment, unfamiliar people, painful procedures, being away from family members and friends, general anesthesia complications such as nausea and vomiting, loss of control, activity limitation. Communication difficulties, dark environments and the presence of other crying children can create fear in children. This situation can be traumatic, especially for children who have difficulty understanding what is happening to them during surgical procedures and who have difficulty coping with such situations that create fear.
In order to provide benefits such as accelerating recovery and increasing nurse-child interaction in the postoperative period, interventions such as pain management and fear reduction should be prioritized. The main purpose of pain management is; Relieving pain is minimizing the resulting fear and side effects. Opioids are the cornerstone of treatment in the field of postoperative pain management in the pediatric population. Despite the benefits and widespread use of opioids in pain management, opioids; It may cause undesirable side effects such as postoperative nausea, vomiting, urinary retention, constipation, respiratory depression, cognitive impairment, addiction, and may prolong hospital stay in children. In studies, the use of multimodal treatment is recommended due to the side effects of opioid use. A combination of pharmacological and non-pharmacological treatments has been shown to reduce dependence on opioids and their side effects, reduce acute pain symptoms and fear in the postoperative period, and increase emotional well-being. In the literature, recent studies on non-pharmacological methods to control pain and reduce fear suggest the use of multi-sensory stimulation to distract children and create a happy and motivating atmosphere.
Multi-sensory stimulation; It is a non-pharmacological method that aims to support the child's developmental stages, reduce behavioral problems, and reduce pain and fear, especially with stimulating materials for the sense of sight, hearing, smell and touch. In its basic mechanism, multisensory stimulation provides multiple stimuli by continuously activating tactile, thermal and emotional systems. This simultaneous stimulation of various sensory systems causes sensory satiation. In this way, gate-control mechanism gates are activated to weaken or suppress nociceptive transmission. Thus, the gate-control mechanism reduces or eliminates the occurrence of pain by closing the gates to prevent nociceptive messages from entering. Multi-sensory stimulation applications include; These include mother-baby communication, skin-to-skin contact, breastfeeding, which activates the sensory receptors on the skin and the sense of taste, and making the baby smell breast milk, amniotic fluid or aromatic scents that it recognizes. Establishing eye contact with the baby, speaking in a soft voice, massaging, wrapping, and using the parent's scent are among the multi-sensory stimulation practices. It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the risk of side effects. Knowing the impact of pain and associated fear on children, developing appropriate pain control strategies is both a medical and ethical responsibility. Reviewing the literature, there is little scientific evidence that multisensory stimulation is an effective intervention in reducing pain and fear after surgery in children. When the studies on the effect of multisensory stimulation on pain and fear in childhood are examined, it is seen that the studies mostly aim to reduce pain and fear in the neonatal period or before surgery. It is thought that it is an important limitation that multisensory stimulation, which is an effective method for reducing pain and fear in childhood, does not examine its direct effects on postoperative pain, physiological parameters and fear after surgical procedures in children. In this context, the aim of the study is to examine the effect of multisensory stimulation on postoperative pain, physiological parameters and fear in children after the surgical procedure.
- Conditions
- Multisensory Stimulation, Child, Only, Postoperative Pain, Fear
- Being tested
- Multisensory Stimulation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory StimulationOther
Multisensory Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Multisensory Stimulation | Experimental | Not described Receives: Other: Multisensory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Information Form
The form prepared by the researchers in line with the literature consists of 19 questions including socio-demographic characteristics, information about the child's disease, and the parent's perception of pain and fear. This form will also record the child's physiological parameters (heart rate and oxygen saturation) during the painful procedure.
Measured: one year
Wong Baker Faces Pain Rating Scale
This scale is rated from 0 to 10. 0 indicates no pain and 10 indicates the most severe pain. Pain is requested to be evaluated according to facial expression. The scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. This scale is used to diagnose pain in children between the ages of 3-18. Wong Baker Pain Rating Scale The guideline recommends that clinicians use a validated pain rating scale when assessing postoperative pain and adjust treatment accordingly (strong recommendation, low-quality evidence), but there is insufficient evidence on the effect of different pain rating scales on postoperative pain outcomes. Therefore, when choosing a specific pain assessment tool, factors such as developmental status, cognitive status, level of consciousness, level of education, cultural and language differences should also be taken into consideration.
Measured: one year
Children's Fear Scale
Children's Fear Scale, the scale whose validity and reliability was established by Gerçeker et al. (2018), is used to measure the child's anxiety level. Children's Fear Scale is a scale that evaluates between 0 and 4, consisting of showing five drawn facial expressions ranging from neutral expression (0 = no fear) to scared face (4 = severe fear). Pain and anxiety before and during the procedure can be used by families and researchers to evaluate children and is intended for children between the ages of 5-10. Children's Fear Scale was created based on McKinley et al.'s (2003) Faces Anxiety Scale, which was developed to measure the fear or anxiety of adults in the intensive care unit. It is a scale consisting of one item and five gender-neutral facets. Facial muscle changes in fearful expressions were drawn by a graphic artist based on photographs of scared faces.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multisensory StimulationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Kos, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237894
- Sponsor's protocol ID
- BSEU
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No planning
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multisensory Stimulation on Postoperative Pain, Physiological Parameters and Fear in Children After Surgical Procedure: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06237894
- Acronym / sponsor ID
- BSEU
- Conditions
- Multisensory Stimulation, Child, Only, Postoperative Pain, Fear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 2 Feb 2024 (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.
It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the risk of side effects. Knowing the impact of pain and associated fear on children, developing appropriate pain control strategies is both a medical and ethical responsibility. Reviewing the literature, there is little scientific evidence that multisensory stimulation is an effective intervention in reducing pain and fear after surgery in children. When the studies on the effect of multisensory stimulation on pain and fear in childhood are examined, it is seen that the studies mostly aim to reduce pain and fear in the neonatal period or before surgery. It is thought that it is an important limitation that multisensory stimulation, which is an effective method for reducing pain and fear in childhood, does not examine its direct effects on postoperative pain, physiological parameters and fear after surgical procedures in children. In this context, the aim of the study is to examine the effect of multisensory stimulation on postoperative pain, physiological parameters and fear in children after the surgical procedure.
Detailed description
The causes of surgery seen in childhood vary according to age. Congenital anomalies are the most common in the neonatal period, and in other age periods, the most common are gastrointestinal system (appendicitis, intussusception, inguinal hernia, etc.) and urogenital system surgeries (circumcision, hydrocele, undescended testicle, testicular torsion, hypospadias, laparoscopic interventions, ovarian cyst and torsion, etc.). They may undergo surgical procedures due to reasons such as .). In a child undergoing a surgical procedure; Postoperative complications such as apnea, airway obstruction, aspiration, extubation, laryngospasm, bronchospasm may occur. One of the most common problems seen in children after surgical procedures is pain. Studies have shown that 24-80% of children who undergo surgery are accompanied by moderate to severe pain. If postoperative pain is not relieved effectively, it may cause negative physiological effects such as increased respiration and pulse, decreased saturation, crying, restlessness, nausea and vomiting, oliguria, impaired immune response, decreased wound healing, and anorexia.
One of the most common problems seen in children after surgical procedures is fear. Postoperative pain that occurs after surgery, different environment and change of routine, different sounds, lights and equipment, unfamiliar people, painful procedures, being away from family members and friends, general anesthesia complications such as nausea and vomiting, loss of control, activity limitation. Communication difficulties, dark environments and the presence of other crying children can create fear in children. This situation can be traumatic, especially for children who have difficulty understanding what is happening to them during surgical procedures and who have difficulty coping with such situations that create fear.
In order to provide benefits such as accelerating recovery and increasing nurse-child interaction in the postoperative period, interventions such as pain management and fear reduction should be prioritized. The main purpose of pain management is; Relieving pain is minimizing the resulting fear and side effects. Opioids are the cornerstone of treatment in the field of postoperative pain management in the pediatric population. Despite the benefits and widespread use of opioids in pain management, opioids; It may cause undesirable side effects such as postoperative nausea, vomiting, urinary retention, constipation, respiratory depression, cognitive impairment, addiction, and may prolong hospital stay in children. In studies, the use of multimodal treatment is recommended due to the side effects of opioid use. A combination of pharmacological and non-pharmacological treatments has been shown to reduce dependence on opioids and their side effects, reduce acute pain symptoms and fear in the postoperative period, and increase emotional well-being. In the literature, recent studies on non-pharmacological methods to control pain and reduce fear suggest the use of multi-sensory stimulation to distract children and create a happy and motivating atmosphere.
Multi-sensory stimulation; It is a non-pharmacological method that aims to support the child's developmental stages, reduce behavioral problems, and reduce pain and fear, especially with stimulating materials for the sense of sight, hearing, smell and touch. In its basic mechanism, multisensory stimulation provides multiple stimuli by continuously activating tactile, thermal and emotional systems. This simultaneous stimulation of various sensory systems causes sensory satiation. In this way, gate-control mechanism gates are activated to weaken or suppress nociceptive transmission. Thus, the gate-control mechanism reduces or eliminates the occurrence of pain by closing the gates to prevent nociceptive messages from entering. Multi-sensory stimulation applications include; These include mother-baby communication, skin-to-skin contact, breastfeeding, which activates the sensory receptors on the skin and the sense of taste, and making the baby smell breast milk, amniotic fluid or aromatic scents that it recognizes. Establishing eye contact with the baby, speaking in a soft voice, massaging, wrapping, and using the parent's scent are among the multi-sensory stimulation practices. It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the risk of side effects. Knowing the impact of pain and associated fear on children, developing appropriate pain control strategies is both a medical and ethical responsibility. Reviewing the literature, there is little scientific evidence that multisensory stimulation is an effective intervention in reducing pain and fear after surgery in children. When the studies on the effect of multisensory stimulation on pain and fear in childhood are examined, it is seen that the studies mostly aim to reduce pain and fear in the neonatal period or before surgery. It is thought that it is an important limitation that multisensory stimulation, which is an effective method for reducing pain and fear in childhood, does not examine its direct effects on postoperative pain, physiological parameters and fear after surgical procedures in children. In this context, the aim of the study is to examine the effect of multisensory stimulation on postoperative pain, physiological parameters and fear in children after the surgical procedure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multisensory Stimulation | Experimental | Other: Multisensory Stimulation |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Hearing and vision impaired
- Does not have a mental disability
- Children who do not have a parental consent form will not be included in the research.
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 StimulationMultisensory Stimulation | Other | Multisensory Stimulation |
Primary outcome
Descriptive Information Form
Time frame: one year
The form prepared by the researchers in line with the literature consists of 19 questions including socio-demographic characteristics, information about the child's disease, and the parent's perception of pain and fear. This form will also record the child's physiological parameters (heart rate and oxygen saturation) during the painful procedure.
Wong Baker Faces Pain Rating Scale
Time frame: one year
This scale is rated from 0 to 10. 0 indicates no pain and 10 indicates the most severe pain. Pain is requested to be evaluated according to facial expression. The scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. This scale is used to diagnose pain in children between the ages of 3-18. Wong Baker Pain Rating Scale The guideline recommends that clinicians use a validated pain rating scale when assessing postoperative pain and adjust treatment accordingly (strong recommendation, low-quality evidence), but there is insufficient evidence on the effect of different pain rating scales on postoperative pain outcomes. Therefore, when choosing a specific pain assessment tool, factors such as developmental status, cognitive status, level of consciousness, level of education, cultural and language differences should also be taken into consideration.
Children's Fear Scale
Time frame: one year
Children's Fear Scale, the scale whose validity and reliability was established by Gerçeker et al. (2018), is used to measure the child's anxiety level. Children's Fear Scale is a scale that evaluates between 0 and 4, consisting of showing five drawn facial expressions ranging from neutral expression (0 = no fear) to scared face (4 = severe fear). Pain and anxiety before and during the procedure can be used by families and researchers to evaluate children and is intended for children between the ages of 5-10. Children's Fear Scale was created based on McKinley et al.'s (2003) Faces Anxiety Scale, which was developed to measure the fear or anxiety of adults in the intensive care unit. It is a scale consisting of one item and five gender-neutral facets. Facial muscle changes in fearful expressions were drawn by a graphic artist based on photographs of scared faces.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No. No planning
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory Stimulation in people with Multisensory Stimulation and Child, Only, run by Bilecik Seyh Edebali Universitesi.
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 0 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Descriptive Information Form (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.