The Effect of Multisensory Stimulus Method on Pain and Physiological Parameters in Infants

NCT06291519 | Completed

• 1 other identifier: SHN50343434
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the impact of employing the multi-sensory stimulation technique by both the mother and the nurse on the pain and physiological responses of infants aged 2-6 months during vaccination. The significance of pain experienced during vaccination in children is emphasized, potentially leading to avoidance behaviors toward healthcare services. There is growing evidence supporting the efficacy of non-pharmacological interventions. Multi-sensory stimulation, which integrates various stimuli such as taste, touch, and speech, alleviates infant pain. However, there has been a lack of studies assessing the effectiveness of this approach during vaccination administered by different healthcare providers. Hence, this study sought to explore the effects of multi-sensory stimulation by both mother and nurse applied to pain and physiological parameters. It is anticipated that the findings of this study will contribute to both pain management strategies and healthcare practices.

Conditions

Multisensory Stimulation

Keywords

Infant baby; Multisensory stimulation; newborns; vaccine; pain; nursing

Outcome Measures

Primary Outcomes (1)

• The Effect of Multiple Sensory Stimulus Method

  The FLACC pain scale score decreased, the oxygen saturation value measured by pulse oximetry was measured higher, the heart rate measured by pulse oximetry was measured lower, and the crying time measured by stopwatch was measured lower in the infants who underwent multisensory stimulus method compared to the control group.

  Measured 5 minutes before, 2 minutes before, immediately before, immediately after, 2 minutes after and 5 minutes after vaccination in all groups

Secondary Outcomes (1)

• Comparison of the group in which the mother applied multiple sensory stimuli and the group in which the nurse applied multiple sensory stimuli

  Measured 5 minutes before, 2 minutes before, immediately before, immediately after, 2 minutes after and 5 minutes after vaccination in all groups

Study Arms (4)

Experimental Group 1

EXPERIMENTAL

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.

Other: Multi-sensory Stimulation Method-Mother Applying the Method to the Baby

Experimental Group 2

EXPERIMENTAL

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.

Other: Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby

Experimental Group 3

EXPERIMENTAL

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.

Other: Breastfeeding Applied Group

Control Group

NO INTERVENTION

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.

Interventions

Multi-sensory Stimulation Method-Mother Applying the Method to the Baby OTHER

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 1

Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby OTHER

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 2

Breastfeeding Applied Group OTHER

Multisensory stimulus method not applied: The baby was breastfed by its mother for 20 minutes. Breastfeeding was stopped just before the vaccination.

Experimental Group 3

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being healthy
• 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

You may not qualify if:

• \- Having taken analgesic, muscle relaxant or sedation within the last 4 hours

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, None Selected, 34381, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 30109720 RESULT

• 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.

  PMID: 32534408 RESULT

• 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.

  PMID: 30993840 RESULT

• 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.

  PMID: 27623411 RESULT

• 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.

  PMID: 22339420 RESULT

• 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.

  PMID: 28920044 RESULT

• Anand KJS, Berqvist L, Hall RW, Carbajal R. (2011). Acute pain management in newborn infants. Pain:Clin Updat.;19(6):1 -6. 11 .

  RESULT

• 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.

  PMID: 32402558 RESULT

• Sahin K, Yildiz S, Gur E. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial. J Pediatr Nurs. 2026 Jan 6;87:20-30. doi: 10.1016/j.pedn.2025.11.051. Online ahead of print.

  PMID: 41500000 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzan Yıldız, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant -( RN, MSc, PhDc)

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 4, 2024
• Study Start: January 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

TU (1)