The Effect of Multisensory Stimulus Method on Pain and Physiological Parameters in Infants
NCT ID: NCT06291519
Last Updated: 2024-03-04
Study Results
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Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2023-01-01
2023-12-30
Brief Summary
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Detailed Description
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One such auspicious non-pharmacological approach to pain management is multisensory stimulation, also recognized as sensory saturation. Multisensory stimulation constitutes a non-pharmacological strategy employed to diminish infant pain during acute procedures. Grounded in gate control theory, it postulates that administering both a sweet taste and a spectrum of stimuli to infants may yield heightened analgesic effects (Bellini et al., 2012). The amalgamation of various interventions such as massage, auditory stimuli, olfactory cues, and eye contact via multisensory stimulation engages broader cortical regions and saturates sensory pathways, thereby attenuating nociceptive inputs (Zeraati et al., 2017).
A review of the literature underscores the efficacy of multisensory stimulation as a non-pharmacological modality to alleviate painful procedures in preterm neonates (Anand et al., 2011). Moreover, it demonstrates superior efficacy compared to single pain relief modalities in mitigating pain during venipuncture in infants (Fitri et al., 2020). Despite the demonstrated efficacy of multisensory stimulation as a straightforward, effective, and safe analgesic method during painful neonatal examinations, studies evaluating its effectiveness during vaccine administration are notably absent. Furthermore, scant research has explored the influence of the practitioner (whether mother, nurse, or physician) on the efficacy of this method.
Hypotheses : Babies who underwent the multi-sensory stimulation method; the Pain scale score is lower than the control group, the crying duration is shorter than the control group, the heart rate is lower than the control group, and the saturation (SPO2) is higher than the control group. In the group where the mother is the practitioner of the Multi-sensory stimulation method, compared to the group where the nurse is the practitioner; the pain scale score is low, the crying duration is low, the heart rate is low, saturation level (SPO2) is high.
Aim:
Hence, this study aims to investigate the impact of multisensory stimulation administered by both mothers and nurses on pain perception and physiological parameters during vaccine administration.
Place and Time of the Research:
The data were collected at the Healthy Child Vaccination Unit of a university hospital by visiting the institution two days a week, on Thursdays and Fridays, between January 2023 and December 2023.
Universe and Sample After obtaining the necessary legal permissions (ethics committee approval and institutional permission), the population of the study consisted of infants between the ages of 2-6 months who were applied to the Istanbul University Cerrahpaşa Medical Faculty vaccination room by their mothers for routine vaccination on the dates of the study.
The research sample consisted of 96 infants between the ages of 2-6 months who were brought to the vaccination room between January 2023 and October 2023, met the inclusion criteria, and whose parents gave written informed consent. According to the power analysis, a total of 96 babies were kept safe, 24 babies per group.
Randomization Babies who met the research selection criteria were the group in which the multi-sensory stimulation method was applied, the approved group of the multi-sensory stimulation method, the experimental group, the breastfeeding group, and the control group according to age (2 months, 4 months, 6 months) in which the block randomization method was mostly applied.
Independent variables: Multi-sensory stimulation method Dependent variables: Duration of infant crying, FLACC pain scale score, peak heart rate, saturation (SPO2) level.
Data Collection Method The data were collected by the researcher in the unit where the research was conducted
Data Collection Tools
* Data Collection Form prepared by the researcher to determine the demographic characteristics of the baby. Some information (such as gestational week, gender, and anthropometric measurements at birth) was obtained from the child's personal records.
* FLACC scale to determine the pain score before, during, and after vaccination of infants,
* Pulse Oximetry Device to detect oxygen saturation (SPO2) and heart rate before, during and after immunization of infants,
* Weighing Instrument for determining the current weight of infants,
* Height Measuring Tape for determining the current height of babies,
* Multi-sensory stimulation method
Procedure The babies included in the study were divided into 4 groups by block randomization method after obtaining ethical and institutional permission. Multi-sensory stimulation method was applied by the mother to the 1st experimental group and by the nurse to the 2nd experimental group. In the breastfeeding group, the mother only breastfed, and no application was applied to the control group.
In all groups, FLACC pain scale, oxygen saturation, and pulse oximetry were evaluated and recorded 5 minutes and 2 minutes before the vaccination process, just before the vaccination, immediately after the vaccination (pain during the procedure), and at the 2nd and 5th minutes after the procedure. Post-vaccination crying duration was recorded in all groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Experimental Group 1
In this group, the mother applied multiple sensory stimuli. In this group, the mothers of the babies to be vaccinated applied multiple sensory stimuli such as breastfeeding, mother's voice, touch-light massage, and eye contact. The mother breastfed her baby for a total of 20 minutes. Breastfeeding was terminated before vaccination. Other applications were applied for 5 minutes before vaccination and 5 minutes after vaccination. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.
Multi-sensory Stimulation Method-Mother Applying the Method to the Baby
In the multisensory stimulus method;
1. st stimulus (sense of taste): The mother breastfed the baby for 20 minutes. Breastfeeding was terminated before vaccination.
2. nd stimulus (sense of touch),: The mother applied touch - a light massage for 5 min until the vaccination process. There was a break just before the vaccination. The application was continued for another 5 min after the vaccination.
3. rd stimulus: Speech-Sound (sense of hearing): The mother spoke to the baby in a soft tone for 5 minutes until the vaccination (words, lullabies, songs, etc.). There was a break just before the vaccination. The practice was continued for 5 minutes immediately after the vaccination.
4\. Stimulus Eye contact (sense of sight): The mother made eye contact with the baby in the mother's field of vision for 5 minutes until the vaccination. There was a break just before the vaccination. The application continued for another 5 minutes after the vaccination.
Experimental Group 2
In this group, the nurse applied multiple sensory stimuli. In this group, the mothers of the babies to be vaccinated breastfed the baby for 20 minutes. The mother stopped breastfeeding before the vaccination procedure. The nurse started to give multisensory stimuli. The nurse administered multisensory stimuli including soft tone of voice, touch-light massage, and eye contact 5 minutes before the vaccination. Other applications were applied 5 minutes before and 5 minutes after vaccination. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.
Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby
In the multisensory stimulus method;
1. st stimulus (sense of taste): The mother breastfed the baby for 20 minutes. Breastfeeding was terminated 5 min before vaccination.
2. nd stimulus (sense of touch),: The nurse applied touch - a light massage for 5 minutes until the vaccination. There was a break just before the vaccination. The application was continued for another 5 min after the vaccination.
3. rd stimulus: Speech-Sound (sense of hearing): The nurse spoke to the baby in a soft tone for 5 minutes until the vaccination (words, lullabies, songs, etc.). There was a break just before the vaccination. The practice was continued for 5 minutes immediately after the vaccination.
4\. Stimulus Eye contact (sense of sight): The nurse made eye contact with the baby in the mother's field of vision for 5 minutes until the vaccination. There was a break just before the vaccination. The application continued for another 5 minutes after the vaccination.
Experimental Group 3
In this group, the mother breastfed her baby for 20 minutes before vaccination. Breastfeeding was terminated before vaccination. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.
Breastfeeding Applied Group
Multisensory stimulus method not applied:
The baby was breastfed by its mother for 20 minutes. Breastfeeding was stopped just before the vaccination.
Control Group
Babies in this group did not receive any treatment. A light touch was applied for ethical reasons. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.
No interventions assigned to this group
Interventions
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Multi-sensory Stimulation Method-Mother Applying the Method to the Baby
In the multisensory stimulus method;
1. st stimulus (sense of taste): The mother breastfed the baby for 20 minutes. Breastfeeding was terminated before vaccination.
2. nd stimulus (sense of touch),: The mother applied touch - a light massage for 5 min until the vaccination process. There was a break just before the vaccination. The application was continued for another 5 min after the vaccination.
3. rd stimulus: Speech-Sound (sense of hearing): The mother spoke to the baby in a soft tone for 5 minutes until the vaccination (words, lullabies, songs, etc.). There was a break just before the vaccination. The practice was continued for 5 minutes immediately after the vaccination.
4\. Stimulus Eye contact (sense of sight): The mother made eye contact with the baby in the mother's field of vision for 5 minutes until the vaccination. There was a break just before the vaccination. The application continued for another 5 minutes after the vaccination.
Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby
In the multisensory stimulus method;
1. st stimulus (sense of taste): The mother breastfed the baby for 20 minutes. Breastfeeding was terminated 5 min before vaccination.
2. nd stimulus (sense of touch),: The nurse applied touch - a light massage for 5 minutes until the vaccination. There was a break just before the vaccination. The application was continued for another 5 min after the vaccination.
3. rd stimulus: Speech-Sound (sense of hearing): The nurse spoke to the baby in a soft tone for 5 minutes until the vaccination (words, lullabies, songs, etc.). There was a break just before the vaccination. The practice was continued for 5 minutes immediately after the vaccination.
4\. Stimulus Eye contact (sense of sight): The nurse made eye contact with the baby in the mother's field of vision for 5 minutes until the vaccination. There was a break just before the vaccination. The application continued for another 5 minutes after the vaccination.
Breastfeeding Applied Group
Multisensory stimulus method not applied:
The baby was breastfed by its mother for 20 minutes. Breastfeeding was stopped just before the vaccination.
Eligibility Criteria
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Inclusion Criteria
* Parental consent to participate in the study
* Born between 38-42 weeks of gestation
* To take part in the routine vaccination programme of the Ministry of Health
Exclusion Criteria
2 Months
6 Months
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Kadriye Sahin
Research Assistant -( RN, MSc, PhDc)
Principal Investigators
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Suzan Yıldız, PhD
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
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Istanbul University-Cerrahpasa
Istanbul, None Selected, Turkey (Türkiye)
Countries
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References
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McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.
Komaroff A, Forest S. Implementing a clinical protocol using breastfeeding to mitigate vaccination pain in infants. J Pediatr Nurs. 2020 Sep-Oct;54:50-57. doi: 10.1016/j.pedn.2020.05.017. Epub 2020 Jun 10.
Aydin D, Inal S. Effects of breastfeeding and heel warming on pain levels during heel stick in neonates. Int J Nurs Pract. 2019 Jun;25(3):e12734. doi: 10.1111/ijn.12734. Epub 2019 Apr 17.
Reece-Stremtan S, Gray L. ABM Clinical Protocol #23: Nonpharmacological Management of Procedure-Related Pain in the Breastfeeding Infant, Revised 2016. Breastfeed Med. 2016 Nov;11:425-429. doi: 10.1089/bfm.2016.29025.srs. Epub 2016 Sep 13.
Bellieni CV, Tei M, Coccina F, Buonocore G. Sensorial saturation for infants' pain. J Matern Fetal Neonatal Med. 2012 Apr;25 Suppl 1:79-81. doi: 10.3109/14767058.2012.663548. Epub 2012 Mar 7.
Zeraati H, Shahinfar J, Behnam Vashani H, Reyhani T. Effect of Multisensory Stimulation on Pain of Eye Examination in Preterm Infants. Anesth Pain Med. 2016 Dec 7;7(1):e42561. doi: 10.5812/aapm.42561. eCollection 2017 Feb.
Anand KJS, Berqvist L, Hall RW, Carbajal R. (2011). Acute pain management in newborn infants. Pain:Clin Updat.;19(6):1 -6. 11 .
Fitri SYR, Lusmilasari L, Juffrie M, Bellieni CV. Modified Sensory Stimulation Using Breastmilk for Reducing Pain Intensity in Neonates in Indonesia: A Randomized Controlled Trial. J Pediatr Nurs. 2020 Jul-Aug;53:e199-e203. doi: 10.1016/j.pedn.2020.04.004. Epub 2020 May 10.
Other Identifiers
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SHN50343434
Identifier Type: -
Identifier Source: org_study_id
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