Plain English Summary
Background and study aims
During treatment in the neonatal ward, infants receive medical and non-medical care that can cause pain. Prevention and treatment of pain in newborns is very important, but in fact, of the many procedures that cause pain, management of pain carried out by health workers is still very limited. The use of glucose or sucrose (sugar) is more effective for pain relief when it is combined with other sensory stimulus (five senses), known as sensorial saturation (SS). SS includes stimulation of five senses: gustatory (taste), visual (sight), tactile (touch), auditory (sound) and olfactory (smell). It is performed by giving a sweet taste, looking at baby’s face, massaging gently, talking quietly, and giving perfume to the nurse’s hand. In this study glucose/sucrose is replaced with breast milk because it is safe and provides a calming effect from its aroma for a long period, making it useable as smell stimulation. The aim of this study is to compare the effects of different multisensory methods using sucrose and breast milk on babies’ pain when undergoing blood sampling.
Who can participate?
2 to 28 day old babies admitted to the neonatal ward and undergoing peripheral blood sampling procedure
What does the study involve?
The babies are randomly allocated into three groups to receive multisensory stimulation with sucrose, multisensory stimulation with breast milk, or sucrose without multisensory stimulation, and their pain is measured when undergoing the blood sampling procedure.
What are the possible benefits and risks of participating?
The benefit of participating is the baby undergoing blood sampling can get treatment for relieving pain. No risks are expected as the treatment is standard procedure in some hospitals.
Where is the study run from?
Two general hospitals in West Java province in Indonesia
When is the study starting and how long is it expected to run for?
January 2017 to December 2018
Who is funding the study?
Ministry of Research, Technology and Higher Education (Indonesia)
Who is the main contact?
Mrs Siti Yuyun Rahayu Fitri
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Siti Yuyun Rahayu Fitri
ORCID ID
http://orcid.org/0000-0002-4816-9935
Contact details
Jl Tulip III No 8 Bumi Rancaekek Kencana
Rancaekek
Bandung
40394
Indonesia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Multisensory stimulation as an effort to reduce pain Intensity in neonates
Acronym
Study hypothesis
1. Analgesia methods of multisensory stimulation using breast milk is no different to multisensory stimulation using sucrose in regard to its effect on pain intensity in neonates
2. Multisensory stimulation using breast milk is better than using sucrose as an analgesia method
3. Analgesia method of multisensory stimulation using sucrose is better than analgesia method using only sucrose regarding pain intensity in neonates
Ethics approval
Medical and health research ethics committee (MHREC) Faculty of Medicine Universitas Gadjah Mada Yogyakarta Indonesia, Gedung Radiopoetro Lt 2 Sayap Barat, Jl. Farmako, Sekip Utara, Yogyakarta, Indonesia 55128, Tel: 0274 588688 pswt 17225 , +62811-2666-869, Email: mhrec_fmugm@ugm.ac.id, No. KE/FK/1193/EC/2017
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
2 to 28 days old babies admitted to neonatal ward who underwent peripheral blood sampling procedure
Intervention
Randomisation with a block randomisation method to 3 interventions:
Multisensory stimulation (modification of sensorial saturation/SS):
1. SS analgesia methods of modified breast milk (test group):
- Prepare 1 cc syringe and 1 cc of breast milk
- Start talking to the baby 30 seconds before blood sample collection
- Gently massage baby’s face
- Bring the breast milk closer to baby’s nose
- Give breast milk until the baby sucks rhythmically
- Perform blood sample collection while doing those maneuvers
- Continue gentle massage and speak to the baby until the end of the procedure
- Measure pain intensity using PIPP-R instrument
2. Standard SS analgesia method (reference group):
- Prepare a vial of sucrose 24 %
- Start talking to the baby 30 seconds before blood sample collection
- Gently massage the baby’s face
- Give sucrose 24 % until he/she sucks rhythmically
- Perform blood sample collection while doing those maneuvers
- Continue gentle massage and talking to the baby until the end of the procedure
- Measure pain intensity using PIPP-R instrument
3. Sucrose 24% analgesia method (control group):
- Prepare the baby for blood sample collection
- Prepare a vial of sucrose 24%
- Give sucrose 24 % until he/she sucks rhythmically
- Perform blood sample collection while doing those maneuvers
- Measure pain intensity using PIPP-R instrument
Intervention type
Other
Phase
Drug names
Primary outcome measure
Pain intensity measured using PIPP-R (Premature Infant Pain Profile-Revised) at a single timepoint
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/01/2017
Overall trial end date
30/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Baby undergoing peripheral blood sampling procedure
2. Minimum APGAR Score of 9 at 5 minutes
3. Gestational age > 32 weeks
4. Postnatal age of 48 hours
5. Sucking and swallowing reflex (+)
6. On treatment for less than 7 days
7. Received breast milk from mother
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
108
Participant exclusion criteria
Neonates who were given analgesic and sedative drug
Recruitment start date
12/04/2018
Recruitment end date
03/08/2018
Locations
Countries of recruitment
Indonesia
Trial participating centre
Universitas Gadjah Mada
Doctoral program faculty of medicine, public health and nursing
Jl. Farmako, Senolowo, Sekip Utara, Sleman
Yogyakarta
55281
Indonesia
Funders
Funder type
Government
Funder name
Kementerian Riset Teknologi Dan Pendidikan Tinggi Republik Indonesia
Alternative name(s)
Kementerian Ristek Dikti, Kementerian Riset dan Teknologi, Ministry of Research, Technology and Higher Education
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Indonesia
Results and Publications
Publication and dissemination plan
Planned publication in BMC Nursing
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Siti Yuyun Rahayu Fitri
Intention to publish date
01/03/2019
Participant level data
Available on request
Basic results (scientific)
Publication list