Reducing pain intensity in neonates by multisensory stimulation

ISRCTN ISRCTN85018057
DOI https://doi.org/10.1186/ISRCTN85018057
Secondary identifying numbers N/A
Submission date
10/01/2019
Registration date
24/01/2019
Last edited
13/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Siti Yuyun Rahayu Fitri
Scientific

Jl Tulip III No 8 Bumi Rancaekek Kencana, Rancaekek
Bandung
40394
Indonesia

ORCiD logoORCID ID 0000-0002-4816-9935

Study information

Study designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleMultisensory stimulation as an effort to reduce pain Intensity in neonates
Study objectives1. 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(s)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
Health condition(s) or problem(s) studied2 to 28 days old babies admitted to neonatal ward who underwent peripheral blood sampling procedure
InterventionRandomisation 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 typeOther
Primary outcome measurePain intensity measured using PIPP-R (Premature Infant Pain Profile-Revised) at a single timepoint
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/01/2017
Completion date30/12/2018

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants108
Total final enrolment108
Key inclusion criteria1. 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
Key exclusion criteriaNeonates who were given analgesic and sedative drug
Date of first enrolment12/04/2018
Date of final enrolment03/08/2018

Locations

Countries of recruitment

  • Indonesia

Study participating centre

Universitas Gadjah Mada
Doctoral program faculty of medicine, public health and nursing
Jl. Farmako, Senolowo, Sekip Utara, Sleman
Yogyakarta
55281
Indonesia

Sponsor information

Universitas Gadjah Mada
University/education

Faculty of medicine, public health and nursing
Jl. Farmako, Senolowo Sekip Utara
Yogyakarta
55281
Indonesia

ROR logo "ROR" https://ror.org/03ke6d638

Funders

Funder type

Government

Kementerian Riset Teknologi Dan Pendidikan Tinggi Republik Indonesia
Government organisation / National government
Alternative name(s)
Ministry of Research, Technology and Higher Education, Kementerian Ristek Dikti, Kementerian Riset dan Teknologi
Location
Indonesia

Results and Publications

Intention to publish date01/03/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in BMC Nursing
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Siti Yuyun Rahayu Fitri

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2020 13/01/2021 Yes No

Editorial Notes

13/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.